Accepted Manuscript

Title: Interventions to support people with dementia and their

caregivers during the transition from home care to nursing
home care: a systematic review

Authors: Christian Müller, Sindy Lautenschläger, Gabriele

Meyer, Astrid Stephan

PII: S0020-7489(17)30086-X
DOI: http://dx.doi.org/doi:10.1016/j.ijnurstu.2017.03.013
Reference: NS 2928

To appear in:

Received date: 30-7-2016

Revised date: 26-3-2017
Accepted date: 31-3-2017

Please cite this article as: Müller, Christian, Lautenschläger, Sindy, Meyer,
Gabriele, Stephan, Astrid, Interventions to support people with dementia
and their caregivers during the transition from home care to nursing
home care: a systematic review.International Journal of Nursing Studies
http://dx.doi.org/10.1016/j.ijnurstu.2017.03.013

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REVIEW PAPER

Title:

Interventions to support people with dementia and their caregivers during the transition from
home care to nursing home care: a systematic review

Authors

Christian MÜLLER ¹ ², Sindy LAUTENSCHLÄGER ³, Gabriele MEYER ¹, Astrid STEPHAN ¹

Job titles and qualifications

Christian MÜLLER ¹ ², B.A., Email: chri.mueller@bagss.de

MScN Student

Sindy LAUTENSCHLÄGER ³, Dr. rer. medic., MScN, Email: s.lautenschlaeger@htwsaar.de

Senior Researcher

Gabriele MEYER ¹, Dr. phil., RN, Email: gabriele.meyer@medizin.uni-halle.de

Professor

Astrid STEPHAN ¹, Dr. rer. medic. MScN, RN, Email: astrid.stephan@medizin.uni-halle.de

Research Fellow

Affiliations

¹ Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-
Wittenberg, Germany

² University of Cooperative Education in Health Care and Welfare Saarland, Saarbrücken,

Germany

³ University of Applied Sciences Saarbrücken, School of Social Sciences, Germany

Complete address for the corresponding author:

Adress: Christian Müller, Bergstrasse 50, 66115 Saarbrücken, Germany

Email: chri.mueller@bagss.de

1
Abstract

Background: During the transition of people with dementia from home to nursing home
family caregivers often feel burdened.

Objectives: We aimed to 1) identify interventions which support people with dementia and
their caregivers in the transition from home care to nursing home care, 2) synthesize the
evidence for efficacy of these interventions, and 3) examine whether the identified
interventions have been systematically developed, evaluated and implemented according to
the Medical Research Council guidance on complex interventions.

Design: A systematic review of randomised controlled trials was conducted according to the
recommendations specified in the Cochrane Handbook for Intervention Reviews. The review
protocol was registered in PROSPERO (2015: CRD42015019839). Reporting follows the
Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA
statement.

Data sources: MEDLINE, CENTRAL, PsycINFO, CINAHL, OTseeker, and PEDro, were
searched. Other sources included Google Scholar, and ALOIS.

Review methods: Two reviewers independently assessed the eligibility of the articles. Data
extraction was performed by one reviewer and verified independently by another. The
Cochrane Risk of Bias tool was used for critical appraisal. Development and evaluation of the
identified interventions were assessed, taking the Medical Research Council guidance into
account. Review findings were synthesized narratively.

Results: The search yielded 1,278 records. Five studies were included, all conducted in the
United States (4 RCTs and 1 cRCT with a total of 695 participants). The psychosocial
interventions were individual and family counseling via telephone or ad hoc all of which
addressed only informal caregivers. The intervention components, content and mode of
delivery differed widely with inconsistent results. Significant intervention effects were found
for the reduction of caregivers’ depressive symptoms, burden, feeling of guilt, emotional
distress, overload, and interactions with staff. Other outcomes, i.e. stress, placement
adaptation, role overload, and role captivity, were not statistically significantly affected. The
assessment for bias risk across studies varied from moderate to low. Only two studies tested
the feasibility of the intervention before full scale evaluation, none evaluated the
implementation process according to the Medical Research Council framework.

2
Conclusions: We identified only a few studies with heterogeneous outcomes; evidence
regarding the effectiveness of psychosocial interventions is thus insufficient. Further research
is needed focusing on the development and evaluation of complex psychosocial
interventions and more well-designed RCTs with larger sample sizes based on a rigorous
methodology. Reporting on feasibility and implementation processes of interventions should
be guaranteed, since it is crucial to evaluate transferability across care settings.

Keywords: dementia; home care; informal caregivers; interventions; nursing; nursing home;
support; systematic review; transition

3
What is already known about the topic?

 The transition from home care to nursing home care is a decisive moment in the life
of persons with dementia and their informal caregivers.
 Informal caregivers suffer from stress, burden, anxiety and often feel unprepared for
the transition period with little information and support.
 Most people with dementia show behavioral and neuropsychiatric symptoms during
the transition period, associated with a lower quality of life, lower general well-being,
anxiety and/or depression.
 Although numerous systematic reviews of non-pharmacological interventions, either
for people with dementia or for informal caregivers, have been published, not one is
dedicated to the transition from home care to nursing home care.

What this paper adds

 This systematic review provides evidence on the effects of psychosocial interventions

supporting informal caregivers during the transition from home care to nursing home
care. None of the included studies targeted people with dementia during this
transition period.
 Psychosocial intervention comprising individual and family counseling, telephone
counseling or ad hoc counseling was found to be the sole strategy used to support
informal caregivers.
 Psychosocial interventions have the potential to improve specific caregivers´
outcome, but the methodological quality of the included studies varied, as did the
intervention characteristics (e.g. components, content, and mode of delivery).
 The review highlights the need for greater attention to the development and
evaluation of complex psychosocial interventions in a stepwise approach according to
the MRC framework and also for more well-designed studies with larger sample sizes
and rigorous methods.

4
Main file:

1. Introduction
The majority of people with dementia live in their own homes and most are cared for by at
least one caregiver, usually a spouse, a partner or a relative (Brodaty and Donkin, 2009;
Boots et al., 2014). These caregivers take care of their loved ones in their homes for months
or years and, during the course of the disease, they provide extensive care and support that
may be physically, emotionally and socially demanding (Brodaty and Donkin, 2009). Recent
studies indicate that caregivers' physical and emotional health often suffers and they are at
increased risk of becoming burdened, stressed, having sleep disturbances, depression and
other health complications (Rose and Lopez, 2012; Li et al., 2012). As dementia progresses
over time and the burden of care exceeds the informal caregiver’s resources, at a certain
point the decision about nursing home placement becomes inevitable (Nikzad-Terhune et al.,
2010). This transition is characterized by different stages, milestones, changes and turning
points prior to, during and after nursing home placement, and this can be a difficult period for
most informal caregivers and people with dementia (Meleis 2010; Afram et al., 2015). From
the caregivers’ point of view, problems become apparent prior to and during admission due
to being unprepared for the transition period, having limited support, being uninformed about
care alternatives or financial options, lacking knowledge about dementia, and having
insufficient exchange of information with healthcare professions (Bramble et al., 2009;
Givens et al., 2012). Dementia caregiving does not end with nursing home placement. After
admission, informal caregivers suffer from emotional concerns, such as self-doubt, feeling
guilty and regretting the placement decision as well as dissatisfaction with staff
communication (Bramble et al., 2009; Afram et al., 2015). Not only informal caregivers, but
also people with dementia are affected. The transition from their home into a nursing home is
a decisive experience for them, representing loss of their home, neighborhood and time with
family and friends compared with previous periods (Sury et al., 2013). Moreover, for most of
those admitted to a nursing home, anxiety, depression and behavioral disturbances occur,
which may have a negative impact on quality of life and general well-being, leading also to
poorer physical health (Brodaty et al., 2001; Scocco et al., 2006). Accordingly, influencing
these circumstances and improving health-related quality of life of people with dementia and
their informal caregivers is imperative. There is a growing need for the provision of
appropriate support for both sides.

Existing systematic reviews of interventions have analyzed trials dealing with a specific type
of intervention either for people with dementia or for informal caregivers, for example 1)
psychosocial interventions to improve behavioral and psychological symptoms in people with
dementia (Testad et al., 2014), 2) social support group interventions for people with dementia
5
(Leung et al., 2015), 3) psychosocial interventions for caregivers (Pusey and Richards 2001;
Brodaty et al., 2003), 4) information and support interventions for caregivers (Thompson et
al., 2007), 5) psychological interventions for caregivers (Selwood et al., 2007) and 6)
internet-based interventions for caregivers dealing with assistive technologies (Boots et al.,
2014). None of these systematic reviews focused on interventions to support people with
dementia and their informal caregivers during the transition from home care to nursing home
care.

2. Objectives and rationale

We carried out this systematic review in order to identify interventions that could effectively
support people with dementia and their informal caregivers during transition from home care
to nursing home care. We described the intervention characteristics carefully (e.g.
components, content, and mode of delivery), and investigated whether the interventions were
systematically developed, evaluated and implemented through a gradual approach as
recommended in the UK Medical Research Council Framework (Craig et al., 2008; Craig et
al., 2013) and the Criteria for Reporting the Development and Evaluation of Complex
Interventions (CReDECI) (Möhler et al., 2015).

The systematic review aimed at answering the following three research questions:

1) What are the characteristics of interventions to support people with dementia and their
informal caregivers during the transition period from home care to nursing home care?

2) Which interventions might work or fail to be effective in supporting people with dementia
and their informal caregivers during the transition period from home care to nursing home
care?

3) In what way do studies follow a systematic approach for development, evaluation and
implementation of interventions?

3. Methods

3. 1 Design

This systematic review was carried out according to a review protocol (Müller et al. 2016)
which has also been published in the Prospective Register of Systematic Reviews
(PROSPERO 2015: Registration number: CRD42015019839). The recommendations
specified in the Cochrane Handbook for Intervention Reviews V.5.1.0 (Higgins and Green,
6
2011) have been followed and reporting follows the Preferred Reporting Items for Systematic
Reviews and Meta-Analyses (PRISMA) statement (Moher et al., 2009).

3.2 Inclusion and exclusion criteria

3.2.1 Study types

Randomised controlled trials (RCTs), cluster-randomised controlled trials (cRCTs) and
clinical controlled trials (CCTs) published in German or English were eligible for inclusion.
Studies without a control group, prospective cohort studies, mixed methods studies, cross-
sectional surveys, case reports or review articles were excluded.

3.2.2 Types of participants

People with dementia

People with mild to severe dementia, who lived at home and were at risk of being admitted to
a nursing home, or who were on a waiting list or who had recently been institutionalized
(nursing home admission ≤ 12 months) were eligible for inclusion. These people received
professional nursing care, a therapeutic treatment program or any other support, regardless
of the type of intervention, from healthcare professionals in their own home or in a nursing
home. Any type of dementia was included.

Informal caregivers of people with dementia

Eligible were informal caregivers, such as spouses, partners, relatives or friends who
provided care for people with dementia on a voluntary basis and who were involved in the
decision-making processes concerning the person they cared for.

3.2.3 Types of settings

Only studies that aimed at supporting people with dementia and their informal caregivers
during the transition from home care to nursing home care were included. Studies conducted
in acute or rehabilitation hospitals, rehabilitation facilities or during respite care were
excluded.

3.2.4 Types of interventions

Interventions were included if they targeted people with dementia or their informal caregivers
with the objective of offering support during the transition from home care to nursing home
care. This transition period refers to the time prior to admission when admission is
contemplated and includes an adjustment period after admission into a nursing home. The
following intervention support components, either alone or in combination, were included:
training in activities of daily living, training in instrumental activities of daily living, education
and counseling, physical or mental treatment, skills training, aid and support for technical
7
equipment, assistive technology, telecare, environmental modification, psychosocial support,
stress management or psycho-educative components. Pharmacological interventions were
excluded.

3.2.5 Types of comparator(s) / control

Studies were eligible if they compared interventions to support people with dementia or their
informal caregivers with standard care or treatment as usual.

3.2.6 Types of outcome measures

Studies were eligible that considered all types of outcomes for people with dementia and/or
their informal caregivers.

3.3 Search strategy

We developed the search strategy according to the Cochrane Handbook of Systematic

Reviews of Interventions (Higgins and Green, 2011) and the standards for literature searches
(Papaioannou et al., 2010; Wu et al., 2012; Sinclair et al., 2013). The following six electronic
databases were searched from their inception until July 15, 2015: MEDLINE (via PubMed),
CENTRAL, PsycINFO, CINAH, OTseeker, and PEDro. Only studies in English or German
were included in the search. The complete search strategy for included databases and
registers has also been published by Müller et al. (2016). Additionally, we searched the
Specialised Register of the Cochrane Dementia and Cognitive Improvement Group (ALOIS)
and we also searched Google Scholar to identify potentially relevant studies not indexed in
electronic databases (full search strategy, see web appendix 1). Finally, backward citation
tracking was applied to identify articles not retrieved by electronic searches.

3.4 Study selection

Studies were selected in two steps. First, pre-defined inclusion criteria were applied to titles
and abstracts of studies identified from the literature search. Studies were screened and
reviewed by two independent reviewers (CM, SL). If title and/or abstract provided insufficient
information to assess the relevance or if a final decision could not be made, we assessed the
full article. Second, full texts of articles selected in the first stage were independently
reviewed manually for final inclusion by the two reviewers. Any discrepancies and/or
disagreement in study selection were resolved by discussion or by consultation with a third
reviewer (AS or GM), if indicated. The PRISMA flow diagram (Figure 1) provides detailed
information regarding the selection process of studies.

8
3.5 Quality appraisal

3.5.1 Risk of bias in individual studies

The Cochrane ‘Risk of Bias (RoB)’ tool (Higgins et al., 2011) was used to evaluate the
potential risk of bias in RCTs. For cRCTs, additional design-related criteria were included in
the quality assessment (e.g. recruitment, baseline imbalance, loss of clusters, statistical
methods) as described by the Cochrane Handbook (Higgins et al., 2011). The following
seven types of bias were evaluated in each included study: a) selection bias (random
sequence generation and allocation concealment), b) performance bias (blinding of
participants and personnel), c) detection bias (blinding of outcome assessment), d) attrition
bias (incomplete outcome data), e) reporting bias (selective reporting), and f) other bias.
Each item was judged independently by two reviewers (CM, SL) as being at ‘low risk’ of bias,
‘high risk’ of bias or an ‘unclear risk’ of bias. If disagreements occurred, these were resolved
through discussion with a third reviewer (AS or GM). The data were imported into Review
Manager ‘RevMan 5’ version 5.3.5, and data analysis was supported by this software. The
results are presented as 'risk of bias' tables for each RCT or cRCT included (Figure 2).
Finally, a narrative description of the risk of bias assessment was used to interpret the
results.

3.5.2 Assessment of individual studies according to the MRC framework

We applied the UK MRC framework (Craig et al., 2008) to assess whether the identified
interventions have been systematically developed, evaluated and implemented through a
gradual approach. According to the MRC framework, complex interventions should be
developed systematically and in an iterative process, starting with a series of pilot studies
and moving on to an exploratory study, followed by a definitive evaluation and finally by
dissemination and long-term implementation (Craig et al., 2013). In this regard, we assessed
whether:

 the development of the identified interventions were grounded on a theoretical basis,

 a clear description of the intervention was provided to enable replication of the study,
 a study registration was performed or a study protocol was published before the study
was conducted,
 the rationale for choosing the intervention components were mentioned,
 information was available about discrepancies between expected and observed
outcomes,
 any information was presented about the feasibility, acceptability and practicability of the
intervention as part of a pilot study,

9
 information about cost-effectiveness was available, and
 whether any information about process evaluation was reported.

The first author searched for supplementary information in eligible studies about trial
protocols, trial registration, feasibility studies, implementation studies, economic evaluation
studies or ongoing studies. This included searching in MEDLINE (via PubMed), trial registries
(WHO International Clinical Trials Registry, International Standard Randomised Controlled
Trial Number (ISRCTN), and ClinicalTrials.gov), and performing a Google search using the
name of the corresponding author, title and key words to identify further information.

3.6 Data Extraction

The Cochrane data extraction sheet for intervention reviews (Cochrane, 2014) was pilot-
tested prior to data extraction. Data were extracted by one reviewer (CM) and checked for
accuracy and completeness by a second reviewer (SL). The following information was
extracted from each included study: a) publication (author(s), year, country of origin), b)
characteristics of participants (e.g. sample size, age, gender, ethnicity, dementia stage), c)
characteristics of intervention(s) and control intervention(s) (enrollment and attrition of
participants, target group (informal caregivers or people with dementia)), healthcare
professionals involved, content and component(s) of intervention(s), theoretical
underpinnings, mode of delivery (frequency, duration, treatment fidelity), d) study setting,
design and methods (aims, recruitment, inclusion/exclusion criteria, ethical approval), e)
information about intervention development, economic evaluation and implementation
strategies, f) outcome measures of interest (primary and secondary measures, methods of
follow-up), and g) main findings.

3.7 Data synthesis

A narrative approach was used to synthesize the findings because the studies were
heterogeneous in terms of design, methods, interventions and outcome measures (Table 1).
The synthesis of the findings contains text and tables to provide a descriptive summary and
explanation of the interventions’ characteristics. Furthermore, this synthesis covered the
main findings of the included studies according to the MRC framework.

4. Results
4.1 Study Selection
The electronic database search and the search in the specialized register ALOIS identified
1366 records of interest: five additional records were identified through our search in Google
Scholar. After duplicates were removed, 1278 records remained, which were screened for
relevance. Screening of titles and abstracts led to exclusion of 1256 studies which did not
10
meet the inclusion criteria and, finally, 22 full text articles were assessed for eligibility. Further
15 studies were excluded (see web appendix 2, reasons for exclusion of full-text articles)
because the interventions did not focus on the transition phase from home care to nursing
home care (n=13) or participants did not fulfill the inclusion criteria (n=1) or the studies had
no control group (n=1). Seven publications were included. Of these, three publications
reported different aspects of the same study investigating the same intervention (Mittelman
et al., 2004; Gaugler et al., 2008 and 2011). Thus, these three publications were handled as
one source for assessing risk of bias and for evaluating study findings. Finally, five studies
were analyzed (Figure 1).

Records identified through Additional records identified

database search through other sources: electronic
Identification

(n =1366) search engine (n = 5)

Records after duplicates removed

(n = 1278)
Screening

Records screened for Records excluded based

titles and abstracts on titles and abstracts
(n = 1278) (n =1256)
Eligibility

Full-text articles assessed Full-text articles excluded,

for eligibility with reasons according to
(n = 22) inclusion/exclusion criteria
(n = 15 )
Included

Studies included (n = 5)

Figure 1 PRISMA flow diagram of the study selection process.

4.2 Characteristics of included studies

All five studies were conducted in the United States and evaluated interventions for
supporting informal caregivers during the transition from home care to nursing home care,

11
but none of the included studies specifically targeted people with dementia during this
transition period (Table 1; Mittelman et al., 2004; Gaugler et al., 2015a; Gaugler et al.,
2015b; Davis et al., 2011; Paun et al., 2015). Four studies were RCTs with parallel group
design and one study was a cRCT (Paun et al., 2015) which allocated long-term care
facilities as units of randomization (Table 1). The studies reviewed included a total of 695
participants (informal caregivers) within their first year following placement of a family
member in a nursing home. The sample size of participants in included studies ranged from
36 to 406. The mean age of informal caregivers varied from 49 to 71 years. In two studies
(Mittelman et al., 2004; Gaugler et al., 2015a), all the patients lived at home with their
spouses or family members at the time of study enrollment. The characteristics of the study
populations varied across the studies. Specific baseline characteristics for people with
dementia were stage of dementia diagnosis (Mittelman et al., 2004), cognitive status
(Gaugler et al., 2015a), length of time since dementia diagnosis (Davis et al., 2011), time
since placement (Davis et al., 2011). For caregivers, the specific characteristics were
relationship with the patient (Davis et al., 2011; Paun et al., 2015), duration of caregiving
(Davis et al., 2011), psychological well-being (Mittelman et al., 2004), caregivers’ stress
(Gaugler et al., 2015a), caregivers’ household annual income (Gaugler et al., 2015a; Gaugler
et al., 2015b), support resources, i.e. social network, assistance or services (Gaugler et al.,
2015a), level of education (Gaugler et al., 2015b), and caregivers’ race/ethnicity (Mittelman
et al., 2004; Gaugler et al., 2015b; Paun et al., 2015).

4.3 Length of follow-up

In all the studies a baseline measurement was carried out. One study (Davis et al., 2011)
had no follow-up. Therefore, this RCT could not show whether the effect persisted over time.
In four studies with follow-up, the time varied from 6 months to 7 years post-completion of the
intervention. Two studies encompassed two follow-up intervals (4- and 8-month follow-up,
Gaugler et al., 2015b; 3- and 6-month follow-up, Paun et al., 2015), one study followed up
participants at 8, 12 and 18 months (Gaugler et al., 2015a) and in one study participants
were observed for up to 7 years (quarterly during the 1 year and twice a year in the
subsequent years) (Mittelman et al., 2004).

4.4 Outcome Measures

One study had one primary outcome (Paun et al., 2015), two studies had two primary
outcomes (Mittelman et al., 2004; Gaugler et al., 2015a), and two studies had three or more
primary outcomes (Davis et al., 2011; Gaugler et al., 2015b). Furthermore, two studies also
used secondary outcomes (Davis et al., 2011; Paun et al., 2015). In total, we found ten
different primary and six secondary outcomes across all the studies. The outcome variable

12
‘caregivers’ depression’ was evaluated most frequently as primary or secondary outcome.
There were inconsistencies between studies with regard to the measures used to assess
depression (Table 1: Mittelman et al., 2004; Davis et al., 2011; Gaugler et al., 2015b; Paun
et al., 2015) and caregiver stress (Table 1: Gaugler et al., 2015a; Gaugler et al., 2015b).
Levels of depression were assessed using two different measures (CES-DS and GDS) and
the outcome ‘caregiver stress’ was assessed using five measures (RMBPC, CRS, FEPFS,
ZBI and PSS) across the studies. Overall, the studies used different measures and
measurement methods to evaluate impact of intervention. A full list of reported primary or
secondary outcomes as well as the questionnaires and self-constructed scales used are
listed in Table 1.

13
Table 1 Characteristics of included studies (n = 5)

Author(s) Country Study Sample Setting Intervention Comparison Outcome(s) Instruments Length of follow-
and year design up
Mittelman USA RCT a n=406 Participants were spouses of IGd: counseling and CGe: usual care* Primary outcomes: 84 months
et al., 2004* (age: mean =71.3 persons with a diagnosis of support intervention 1) caregivers´ depression GDS f (7 years)
years, SD=9.0) ADRDc living at home in the program* *Services provided to 2) depressive symptoms mZBI g
. New York City metropolitan all families of patients: (in the first year 4-
area at the time of study *Consisted of 3 information about Secondary outcome(s): month, 8-month
enrollment components: resources and advice not investigated and 12-month
individual and family upon request, in crises follow-ups) and
counseling, support free to participate in every 6 months
group participation, ad hoc counseling thereafter)
and ad hoc counseling
*The three publications by Mittelman et al., 2004; Gaugler et al., 2008 and 2011 were handled as one source for reporting study findings.

Gaugler et USA RCT n=107 Participants were child IG: multicomponent CG: usual care* Primary outcomes: 18 months
al., 2015a (age: mean caregivers of parents with psychosocial 1) support resources SSNLh
=50.46 years, SD ADRD in the Minneapolis/St. counseling and *In crises counselors 2) caregiver stress RMBPC I, CRS j, (over 8, 12 and 18
= 8.24) Paul region support intervention were instructed to FEPFS k months)
offer brief consultation Secondary outcome(s):
not investigated
Gaugler et USA RCT n=36 Participants were family IG; psychosocial CG: usual care Primary outcomes: 8 months
al., 2015b (age: mean caregivers of relatives in intervention program* 1) caregiver stress ZBI l, PSS m
=62.67, SD = a nursing home in the 2) depressive symptoms CES-DS n, GDS (over 4- and 8-
7.43) *Family counseling as 3) caregiver adaptation to month follow-ups)
region of Minnesota FCPRQ o, RRQ p
well as support for placement
other family members
or decision- makers Secondary outcome(s):
not investigated
Davis et al., USA RCT n=53 Participants were family IG: telephone- CG: usual care* Primary outcomes: Post-intervention
2011 (age: mean caregivers of relatives in a delivered psychosocial 1) caregiver guilt CGQNHP q measurement
=59.28 years, SD nursing home in the greater support program *Current standard of 2) depression CES-DS
= 10.56) Providence, Rhode Island care for caregivers; ZBI
3) burden
area community-based 4) hassles with staff NHHS r
mental health and 5) facility satisfaction ODAFSI s
support resources
6) resource use RUQ t

Secondary outcomes:
1) visitation frequency
2) quality of life
3) social support
4) negative reactions to care

14
Paun et al., USA cRCT b n=93 16 long-term care facilities IG: group-based CG: usual care Primary outcomes: 6 months
2015 (age: mean (non-profit and profit-making psychosocial 1) chronic grief MM-CGI w
=60.69 years, SD nursing homes) spread over intervention program (over 3- and 6-
= 10.64) three counties in urban and Secondary outcomes: month follow-ups)
suburban areas. 1) depression CES-DS
2) knowledge and skill KAT u, FPCR v

a Randomised Controlled Trials (RCT).

b Cluster-Randomised Controlled Trial (cRCT).
c Alzheimer's Disease and Related Dementia (ADRD).
d Intervention group (IG).
e Control group (CG).
f Geriatric Depression Scale (GDS): A 30-item self-report questionnaire to measure spouse caregivers’ mood and psychological well-being.
g Modified Zarit Burden Interview (mZBI): A15-item questionnaire to measure stress (e.g., emotional distress, financial strain, guilt, and overall burden).
h Stokes Social Network List (SSNL): Questionnaire to measure the size and composition (i.e., number of close friends/relatives) of the caregiver’s social network as well as service utilization.
i Revised Memory and Behavior Problems Checklist (RMBPC).
j Caregiving Role Scale (CRS): A three-item scale assessed the involuntary aspects of the caregiving role (i.e., role captivity).
k Feelings of Emotional and Physical Fatigue Scale (FEPFS): A four-item scale measured caregivers’ feelings of emotional and physical fatigue (i.e., role overload).
l Zarit Burden Interview (ZBI): A 7-item questionnaire to measure caregivers’ stress.
m Perceived Stress Scale (PSS): A 10-item scale to measure caregivers’ stress.
n Center for Epidemiologic Studies-Depression Scale (CES-DS): A 20-item scale to assess caregivers´ depressive symptoms.
o Family Caregiver Perception Role Questionnaire (FCPRQ): A 25-item questionnaire to measure family members’ degree of satisfaction with residential care staff.
p Relationship Relative Questionnaire (RRQ): A questionnaire to measure the closeness of relationship with the relative.
q Caregiver Guilt Questionnaire for Nursing Home Placement (CGQNHP): A 46-item scale to assess feelings of guilt related to placing a family member in nursing home care.
r Nursing Home Hassles Scale (NHHS): A 29 item scale to assess the degree of the caregiver’s experience of hassles with the nursing home staff.
s Ohio Department of Aging Family Satisfaction Instrument (ODAFSI): A 62 item scale assessing family members’ satisfaction with the nursing home placement.
t Resource Use Questionnaire (RUQ): A questionnaire to assess the use of services such as support groups, mental health services, educational resources, community transportation, and

spiritual guidance.
u Knowledge of Alzheimer’s Test (KAT): A 22-item questionnaire to measure caregivers’ knowledge about the disease process, resident behaviors, and care of the resident with ADRD in long-

term care facilities.

v Family Perception of Caregiving Role (FPCR): A questionnaire to measure caregiver conflict with nursing home staff related to caregiving.
w Marwit-Meuser Caregiver Grief Inventory (MM-CGI): A 50-item questionnaire to assess grief in caregivers of persons with AD.

15
4.5 Risk of bias in individual studies

The assessment of risk of bias in all included studies indicated variations in the internal
validity of studies (Figure 2). Four studies reported adequate random sequence generation
(Mittelman et al., 2004; Davis et al., 2011; Gaugler et al., 2015a; Gaugler et al., 2015b), but
in one study (Paun et al., 2015) insufficient reporting resulted in an ‘unclear’ judgment. All
included studies were rated as ‘unclear’ risk of bias regarding allocation concealment due to
insufficient information. Two studies (Mittelman et al., 2004; Gaugler et al., 2015b) were
stated as non-blinded. However, three studies (Davis et al., 2011; Gaugler et al., 2015a;
Paun et al., 2015) did not provide any information on whether blinding of participants and
personnel took place. High risk for detection bias was assessed in two studies (Mittelman et
al., 2004; Gaugler et al., 2015b) due to the outcome assessors’ knowledge of the allocated
interventions, and in one study (Paun et al., 2015) the trial report contained insufficient
information. Regarding attrition bias, three studies (Davis et al., 2011; Gaugler et al., 2015a;
Gaugler et al., 2015b) were rated as high risk of bias. Two studies (Gaugler et al., 2015a;
Davis et al., 2011) were judged to be at high risk of bias for selective outcome reporting, due
to deviation from pre-specified analysis of outcomes. Furthermore, three studies (Mittelman
et al., 2004; Gaugler et al., 2015b; Paun et al., 2015) were rated as ‘unclear’ risk for potential
selective reporting due to insufficient information.

16
Figure 2 Risk of bias summary
Note: The studies by Mittelman, 2004; Gaugler et al., 2008 and Gaugler et al., 2011 were handled as one source
for the Risk of Bias assessment

4.6 Summary of studies and findings

The characteristics of interventions and their effects are described below. Additional
information and an overview of the five studies are displayed in Table 1.

4.6.1 Question 1: Description of interventions

The New York University Caregiver Intervention (NYUCI) by Mittelman et al. (2004) and
Gaugler et al. (2008 and 2011) comprised psychosocial counseling and support to reduce
the burden and depressive symptoms of caregivers before and after nursing home
admission. The New York University Caregiver Intervention for Adult Children (NYUCI-AC)
by Gaugler et al. (2015a) especially addressed adult child dementia caregivers with the
objective of helping adult children cope with disruptive behaviors of people with dementia,
and of helping caregivers communicate their needs to family members and others. The

17
Residential Care Transition Module (RCTM) intervention by Gaugler et al. (2015b) supported
family members in identifying potential stressors arising from the transition and assisted them
in using coping strategies for these stressors. The Family Intervention Telephone Tracking
Nursing Home (FITT-NH) by Davis et al. (2011) was designed to help caregivers adjust to
the burden and stress of nursing home placement in the first few months after placement.
The intervention focused on issues associated with acute placement stressors like family–
staff interaction, satisfaction with the facility, and guilt about the placement decision. The
Chronic Grief Management Intervention (CGMI) by Paun et al. (2015) focused on caregivers’
chronic grief (e.g. recognizing losses, processing reactions to separation, re-experiencing the
relationship with the care receiver) within their first year following placement of a family
member in a nursing home.

Distinct intervention characteristics were evaluated in relation to psychosocial support

interventions, i.e. method of delivery (amount of time per support session, number of
sessions per week, duration of intervention period), contents and components of
interventions. All the studies investigated multi-component psychosocial interventions with a
combination of various forms of counseling and support treatment components. The
interventions comprised individual and family counseling (Mittelman et al., 2004; Gaugler et
al., 2015a), telephone counseling (Davis et al., 2011) or ad hoc counseling either in-person,
over the phone, or via e-mail (Mittelman et al., 2004; Gaugler et al., 2015a; Gaugler et al.,
2015b). All of the studies reported in-person, individual and family counseling, except the
study by Davis et al. (2011) where counseling and support to caregivers were entirely by
telephone. A variety of different treatment content modalities encompassed the psychosocial
interventions as displayed in Figure 3. The mode of delivery also varied across studies. In
three studies, the intervention was provided by counselors with advanced degrees in social
work or allied professions (Mittelman et al., 2004; Gaugler et al., 2015a; Gaugler et al.,
2015b), in one study psychosocial interventions were carried out by therapists without
specifying which professional discipline was involved (Davis et al., 2011), and in another
study the intervention was provided by advanced practice psychiatric nurses (Paun et al.,
2015).

Description of control interventions

In two studies, caregivers were allowed to use the current standard of care, such as
community-based mental health and/or support resources, but they did not receive any
support sessions (Mittelman et al., 2004; Davis et al., 2011). Three studies used contact
control groups (Gaugler et al., 2015a; Gaugler et al., 2015b; Paun et al., 2015). In one study,
caregivers received a biannual project newsletter, quarterly check-in calls and, if a critical

18
need arose, a brief consultation with counselors (Gaugler et al., 2015a). In two other studies,
caregivers received brief phone calls to maintain contact, but they did not receive any
psychosocial consultation (Gaugler et al., 2015b; Paun et al., 2015).

4.6.2 Question 2: Evaluation effects of interventions

Four studies measured the outcomes beyond completion of the intervention up to the seven-
year follow-up (Mittelman et al., 2004; Gaugler et al., 2008 and 2011; Gaugler et al., 2015a;
Gaugler et al., 2015b; Paun et al., 2015), and one study reported post-intervention
measurement (Davis et al., 2011). The evaluation indicated that there was heterogeneity
between the studies based on long- and short-term effects of interventions and outcome
measures used. Therefore, these studies are described in detail hereafter.

Primary outcomes
The NYUCI-study by Mittelman et al. (2004) evaluated long-term effects of intervention on
caregivers’ depressive symptoms from the end of year one through year five after baseline.
At the one-year follow-up, the difference in the change on depression scores between the
intervention group (M=–1.1, SD=5.0) and the usual care group (M=0.3, SD=6.0) was
statistically significant (F=6.40, df=1, p=0.02). At baseline, differences between groups were
found with regard to gender composition (p=0.03) and depressive symptoms (p=0.01). After
baseline differences were checked, caregivers in the intervention group had significantly
lower depression scores (p<0.05) than caregivers in the control group at the 3-year follow-up.
Regarding the five-year follow-up, the proportion of subjects above the threshold for clinically
significant depression remained higher in the control group (corresponding rates were
45.1%, 31.9%, and 30.0% for 1, 3, and 5 years after baseline) throughout the five years of
the analysis than for the intervention group (corresponding rates were 29.8%, 26.2% and
27.0% for 1, 3, and 5 years after baseline). The findings reported by Gaugler et al. (2008)
indicated that the burden of the intervention group was significantly lower than the burden of
the usual care group at the time of and after nursing home admission (difference in estimates
E=-1.15, SE=0.30, p<0.03), and the difference at 3 years before placement closely
approached statistical significance (E=-1.56, SE=0.39, p=0.06). Moreover, significant
intervention effects were found for reduction of depressive symptoms after nursing home
admission (E=-0.49, SE=0.18, p=0.009). Baseline data indicated a gender imbalance in the
NYUCI -study, with more women in the usual care group (65.0%) than in the intervention
group (53.9%). Baseline depression scores also varied between intervention and control
groups. Furthermore, the NYUCI-study evaluated the effects of psychosocial support on
spouse caregivers’ burden and depressive symptoms in relation to gender differences during
the nursing home placement. The study report by Gaugler et al. (2011) showed that women
in the control group revealed an increase of burden (approximately 2 points on the ZBI) prior
19
to nursing home admission in comparison to husbands. Immediately after nursing home
admission, wives reported greater decreases in depressive symptoms (approximately 2 or
more points on the GDS) when compared to husbands (approximately 1 point or less on the
GDS).

The NYUCI-AC study by Gaugler et al. (2015a) found that adult child caregivers in the
intervention group indicated statistically significant decreases in overall negative reactions to
behavior problems over a 12-months' period (B=−2.16, SE=0.67, p<0.01, −2LL [log likelihood
ratio]=1,286.98) compared with the control group. Furthermore, caregivers in the NYUCI-AC
also indicated greater decreases in negative reactions to disruptive behavior problems when
compared with checks after eight months (B=−3.23, SE=1.00, p<0.01, −2LL [log likelihood
ratio]=936.76), 12-months (B=−2.27, SE=0.71, p<0.01, −2LL= 1,161.62), and 18 months
(B=−1.34, SE=0.43, p<0.01, −2LL=1,528.15) . The intervention had no effect on frequency of
behavior problems, role overload or role captivity.

The RCTM intervention by Gaugler et al. (2015b) showed that caregivers in the intervention
group had significantly less emotional distress (F=6.13, p=0.02) at the 4-month follow-up
(M=7.84, SD=6.27) than those in the control group (M=14.50, SD=7.87). Furthermore,
caregivers in the RCTM intervention group reported less overload (F=5.00, p=0.04) at the 8-
month follow-up (M=2.97, SD=0.92) compared to the control group (M=3.71, SD=0.77). The
intervention group and control group did not differ significantly on any baseline variables.
Due to the small sample, a number of findings according to the primary outcomes stress,
depressive symptoms and caregiver adaptation to placement did not achieve statistical
significance below the p<0.05 threshold, but tended towards the expected clinical direction
(p≤0.10).

The FITT-NH study by Davis et al. (2011) evaluated burden and stress due to nursing home
placement. At baseline, groups did not differ in caregiver age, education, gender, duration of
caregiving, length of time since dementia diagnosis or since placement. The study reported
that the intervention led to significant reduction in caregivers’ feelings of guilt (F=5.00,
p=0.03) related to placement (M=36.96, SD=31.40) compared to standard care (M=29.14,
SD=25.91), and significantly less bother with staff in the intervention group (F=6.20, p=0.02),
i.e. the degree of the caregiver’s experience of trouble with the nursing home staff (M=6.71,
SD=9.77) compared to standard care (M=4.90, SD=6.20). No effect of the intervention was
found regarding the primary outcomes depression, burden, facility satisfaction, resource use.

20
The chronic grief management intervention by Paun et al. (2015) showed significant
improvement in caregivers’ sadness and longing at the 3-month follow-up (F=5.04,
ES=0.494, p=0.027) in the intervention group (M=−3.03, SD=9.58) in comparison with the
control group (M=0.8, SD=5.93) and a significant drop in their feeling of guilt at the 6-month
follow-up (F=4.93, ES=0.492, p=0.29) for the intervention group (M=−1.65, SD=4.95) and the
control group (M=0.67, SD=4.49), whereas at the 6-month follow-up no significant effects
were found on caregivers’ burden, genuine sadness and longing, as well as worry and
isolation. At baseline, the overall levels of chronic grief and guilt were not significantly
different between the groups, but baseline comparisons of study outcomes indicated that
caregivers in the intervention group differed significantly from participants in the control group
in relation to two components of grief, i.e. they experienced a higher sense of loss of
relationship (p=0.007) and a higher level of sadness and longing (p=0.017).

Secondary outcomes

Only two studies reported results on secondary outcomes (Davis et al., 2011; Paun et al.,
2015). In the study by Davis et al. (2011), visitation frequency, health-related quality of life,
social support and negative reactions to care were the measures used. No significant post-
intervention improvements in the intervention group were found for any secondary outcome.
In the study by Paun et al. (2015), at 3- and 6-month follow-up, no significant intervention
effects on caregivers’ depression, knowledge and skills were observed.

21
Figure 3 Overview of intervention content and mode of delivery

Intervention content modalities Mittelman et al., Gaugler et al., Gaugler et al., Davis et al., Paun et al.,
2004 2015a 2015b 2011 2015
Development of coping strategies
X X
Problem solving
X X
Development of communication skills
X X X
Conflict resolution skills
X
Chronic grief management
X
Education and knowledge about ADRD
X X
Emotional support
X X
Development of skills to cope with and adapt to disruptive behaviors of people
X X
with dementia

Treatment period

1 Month 2 Months 3 Months 4 Months 5 Months 6 Months

Mode of delivery of interventions

Six sessions of individual and/or family counseling during 4

months 6 Sessions
Mittelman et al., 2004; Gaugler et al., 2015a; Gaugler et al., 2015b

10 individual telephone contacts over 3 months

Davis et al., 2011 10 Contacts

12 group-based sessions during 3 months:

Paun et al., 2015 12 Sessions

22
The duration of sessions

Time / Minutes (Minimum to Maximum) 10 20 30 40 50 60 70 80 90 100 110 120

12 to 60 minute sessions; initial contact lasting 90 minutes:

Paun et al., 2015 12 to 60 minutes

35 to 45 minute sessions; initial contact lasting 60 minutes:

Davis et al.,2011

60 to 120 minutes:
Gaugler et al., 2015b 60 to 120 minutes

The studies by Mittelman et al. (2004) and Gaugler et al. (2015a) provided
insufficient information about duration of sessions.

23
4.6.3 Question 3: Appraisal of study findings according to the MRC framework

Phase 1: Developing a complex intervention

In all five studies, the background was evidence-based. In none of the studies had interviews
or focus groups been conducted with people with dementia, informal caregivers or healthcare
providers in order to explore the interventions’ components (content, strategy or delivery of
intervention). In all the studies referred to theoretical frameworks had been published to
support the grounds for the interventions or to locate interventions within a theoretical model.
All of them are related to the psychological grounding concerning the stress process model
by Pearlin et al. (1990) or by Lazarus and Folkman (1984). Two of the five studies (Mittelman
et al., 2004; Gaugler et al., 2015b) referred to the transition theory by Meleis (Chick and
Meleis, 1986; Meleis et al., 2000). For supplemental material, see web appendix 3.
Regarding modeling of process and outcomes, a modeling approach was used in the
NYUCI-study (Mittelman et al., 2004), in the NYUCI-AC-study (Gaugler et al., 2015a) and in
the FITT-NH-study (Davis et al., 2011) to design the intervention, to identify suitable
measures, and to predict long-term outcomes based on the authors’ previously reported
findings. A range of different published standardized scales, or non-standardized author-
developed scales were used (Table 1). Most studies used multiple measures to evaluate
intervention impact. None of the included studies were registered, and no study protocols
had been published (Table 2).

Phase II: Feasibility Study by Piloting Intervention

Only two studies conducted a feasibility study before the main trial (Gaugler et al., 2015b;
Paun et al., 2015). Gaugler et al. (2015b) tested procedures to ensure that the intervention
was acceptable and feasible. Questions raised concerned whether the psychosocial support
was perceived as helpful, which other services would have been helpful, or what kind of
support and resource information had been necessary. The study included estimating the
rates of recruitment and retention of subjects, calculating an appropriate sample size as well
as the evaluation of the caregivers’ satisfaction with the program (Table 2). Paun et al.
(2015) tested the recruitment and evaluated the retention, tested procedures for staff
acceptability, measured treatment fidelity by staff, calculated the effect size, and evaluated
the caregivers’ satisfaction with the program (Table 2).

Phase III: Evaluating the complex intervention

None of the included studies reported on process evaluation strategies alongside the full trial
to obtain information about factors that potentially influenced the effectiveness of the
intervention and to identify factors that would facilitate the future implementation of the

24
intervention (e.g. performance of the intervention according to protocol, adherence of
participants and fidelity of intervention delivery). None of the studies evaluated the cost-
effectiveness or reported any information regarding adaption of interventions, i.e. whether the
interventions underwent tailoring when delivered in the specific context during the transition
from home care to nursing home care (for supplemental information, see web appendix 4).
No adverse events appeared in the study by Davis et al. (2011) whereas the other studies
supplied no further information about adverse events mentioned.

Phase IV: Implementation of Interventions

With regard to dissemination, most of the published study reports did not describe the
interventions in enough detail to enable replication. Neither the study protocols nor the
training materials nor the intervention manuals nor the fidelity checklists were available in the
public domain via websites for other researchers. Only the CGMI-study by Paun et al. (2015)
offered some additional information about the intervention development and the
implementation strategy published in a scientific journal (Paun and Farran, 2011); further
information about the NYUCI-study was published in a scientific book to bring these
experiences to the attention of a wider public (Mittelman et al., 2002). None of the studies
evaluated the implementation process (surveillance, monitoring), or the implementation of
long-term follow-ups according to the MRC-framework. However, the studies did not give any
indication of whether a national dissemination and implementation study is planned in the
future.

25
Table 2 Findings of included studies mapped to the phases of the MRC framework (MRC 2006) and the CReDECI criteria (Möhler et al. 2015)

Developing a complex Assessing feasibility of Evaluating a complex Implementating a complex

intervention the intervention intervention intervention

Mittelman et Gaugler et al., Gaugler et al., Davis et al., Paun et al.,

al., 2004 2015a 2015b 2011 2015

Developing a complex intervention

1. Identifying the evidence base ¹     X

2. Identifying/ developing theory ¹     

3. Modeling process and outcomes ¹     

4. Study registration X X X X X

5. Study protocol X X X X X

6. Developing of a intervention manual X  X  

7. Description of all components of the intervention ²     

8. Rationale for the selection of the intervention’s components ²     

9. Illustration of any intended interactions between different components ² X X X X X

10. Consideration of contextual factors and determinants of the setting in the ? ? ? ? ?
modeling of the intervention ²

Feasibility

1. Estimating recruitment and retention ¹ X X  X 

2. Testing procedures for patient acceptability ¹ X X  X X

3. Testing procedures for staff acceptability ¹ X X X X 

4. Measuring treatment adherence¹ / staff X X X X 

26
5. Evaluation of program satisfaction / caregivers X X  X 

6. Determining sample size¹ X X  X 

7. Information on pilot-testing ² X X  X 

8. Description of facilitators or barriers revealed by the process evaluation ² X X  X X

Evaluation

1. Assessing effectiveness ¹     

2. Understanding change process ¹: Process evaluation a (e.g. assessment of X X X X X

fidelity and quality of intervention delivery)

3. Assessing cost-effectiveness¹ b X X X X
4. Accessibility of all materials or tools used to allow a replication of the study ² ≈ X X X ≈

5. Description of unexpected interactions between components and the context X X X X X

in which the intervention was delivered ²

Implementation

1. Dissemination strategy described ¹ X X X X X

2. Surveillance and monitoring ¹ X X X X X

3. Long term follow -up ¹ X X X X X

Criterion fulfilled; X: criterion not fulfilled; ?: data not provided from the study report or unclear; ≈: criterion partially fulfilled or rather limited availability.
¹ Criteria of the Medical Research Council (MRC) Framework, a framework for the development and evaluation of complex interventions.
² Criteria for Reporting the Development and Evaluation of Complex Interventions (CReDECI), a criteria list comprising 16 items for improvement of the quality of reporting of
studies on complex interventions’ development and evaluation before long-term implementation.
a In phase III evaluating effectiveness, the emphasis of process evaluation shifts towards providing greater confidence in study results about effectiveness by assessing what was

delivered, and assessing the generalisability of its effectiveness by understanding the role of context.
b An ongoing study of NYUCI was conducted beginning in the year 2010. The trial estimated the potential savings to Minnesota from offering the NYUCI Intervention (Long et al.,

2014).

27
5. Discussion
5.1 Summary of evidence
This systematic review evaluated the components, content, mode of delivery and effects of
interventions supporting informal caregivers of people with dementia during the transition
from home care to nursing home care, as well as the research steps in the process of
developing and evaluating these complex interventions. The review was also intended to
identify interventions to support people with dementia during the transition, but all the
included studies focused only on interventions supporting caregivers during the transition
from home care to nursing home care. Five studies (four RCTs and one cRCT) were
included with methodological qualities ranging from moderate to low. The main problems
were lack of blinding of participants and outcome assessors, inadequate outcome reporting,
as well as not following intention to treat. Furthermore, several studies had a small number of
participants and, consequently, low statistical power to show differences between the groups.
The Cochrane 'Risk of Bias' assessment tool showed that the vast majority of studies had
either high risk of bias or unclear risk of bias and such factors would be expected to have the
potential to overestimate intervention effects. Significant intervention effects were found:
caregivers’ depressive symptoms were reduced up to the 3-year follow-up (Mittelman et al.,
2004; Gaugler et al., 2008; Gaugler et al., 2011), as were caregivers’ burden (Gaugler et al.,
2008, 2011 and 2015b), emotional distress, role overload, and negative reactions to behavior
problems up to the 8-months and 18-months follow-ups (Gaugler et al., 2015a; Gaugler et
al., 2015b). Caregivers’ chronic grief and guilt were reduced up to the 6-months follow-up
(Paun et al., 2015), and there was also a decrease in feelings of guilt and positive
interactions with staff post-intervention (Davis et al., 2011). Moreover, non-significant effects
of interventions were found on the outcomes: stress, depressive symptoms, caregivers’
adaptation to placement, role overload, role captivity, and frequency of behavior problems,
i.e. behaviour changes observed in the family members suffering from dementia (Gaugler et
al., 2015a and 2015b). The current evidence is too limited to be confident about the effects of
interventions, thus making it difficult to draw robust conclusions from the findings. Most of the
studies used several measures to evaluate impact of intervention. This may be explained by
the fact that studies grounded their interventions on different theoretical models, or used
different types of intervention in different settings (e.g. prior to, during or after the transition
from home to nursing home) or had different understandings about their level of action
mechanisms.

5.2 Main findings according to intervention components, content and delivery

There was considerable heterogeneity concerning components, content, and delivery of
interventions. Our review showed that the mode of delivery differed between the included
studies. The duration of sessions ranged from a minimum of 12 minutes to 120 minutes per
28
session, and a variation in the length of the interventions was observed, ranging from three
to four months. In the light of the main findings, we can state that psychosocial intervention
components, i.e. in-person or group counseling for individuals or families, telephone
counseling, or ad hoc counseling are essential components, whereas the best mode of
delivery could not be specified. Few studies contained detailed information on the
professional who dispensed the intervention. In those studies that contained this information,
only social workers and advanced psychiatric nurses were specified as professionals. The
optimal mode of delivery as well as adequate competences and the level of professional
education are, however, yet to be established, these being factors that could potentially
influence the intervention effects. Existing literature indicates that other healthcare
professionals, e.g. occupational therapists, physiotherapists, speech therapists,
psychologists as well as volunteers also play an important role supporting people with
dementia, on the one hand by training activities of daily living (ADL) and cognitive and
physical functions and, on the other hand, by supporting caregivers through teaching skills,
helping with conflict resolution, training in the use of communication strategies, care
planning, organizing services, as well as providing advice for physical environmental
modifications (NICE and SCIE, 2007; Kaur et al., 2012; Kim et al., 2012; Elvisha et al., 2013).
This should be taken into account when designing complex interventions for future studies.
The comparison of theoretical frameworks showed that four of the five studies used the
stress process model by Pearlin (1990) to underpin the counseling and education approach,
but only two of the five based their intervention on the theory of transition by Meleis
(Mittelman et al., 2004; Gaugler et al., 2015b). Across all the studies, further theoretical
frameworks were used, e.g. care transitions by Parry and colleagues (2003), psychosocial
transition by Tyhurst (1958), or the system view of family functioning by Ryan and colleagues
(2005). Remarkably, most studies provided an unfortunately incomplete description of the
intervention, and in those studies that used an intervention manual, this was not available in
the public domain via websites. As a consequence, clinicians cannot reliably implement
interventions that are shown to be effective, and for other researchers it is difficult to replicate
the research findings. Future publications on psychosocial interventions are urgently
requested to respect the ‘Template for Intervention Description and Replication’ (TIDieR)
checklist (Hoffmann et al., 2014). In addition, reporting in relation to fidelity of intervention
delivery was often poor. It should be noted that the evaluation of participants’ program
satisfaction as well as the treatment fidelity might contribute to better understanding the
interpretations of intervention effects.

29
5.3 Main findings according to the MRC-Framework:
All the included studies could be considered as complex interventions according to the MRC-
Framework (Craig et al., 2008). Our results indicate that a more gradual development of
complex interventions is warranted, including modeling of components, pilot testing of
feasibility (e.g. recruitment and retention, treatment fidelity or determining sample size) and
testing of acceptability (e.g. participants acceptability, staff acceptability), because three of
the five studies did not follow this gradual approach (Mittelman et al., 2004; Davis et al.,
2011; Gaugler et al., 2015a). Only the studies by Gaugler et al. (2015b) and Paun et al.
(2015) took up these MRC-Framework issues in their study designs. None of the studies
evaluated the implementation process, or the implementation of long-term follow-up or the
cost-effectiveness. Overall, applying process evaluation and assessing cost-effectiveness is
warranted in order to evaluate the degree to which the interventions were implemented and
to ensure that resources are being used as wisely as possible.

5.4 Strengths and limitations

We included studies which comprised interventions delivered by all kind of healthcare
professionals and we did not place restrictions on the outcomes or the intervention
components in advance. The strengths of our review is the detailed analysis of data relating
to intervention content, components, mode of delivery, and the analysis of the interventions
according to the MRC-framework. There are limitations that should be considered when
interpreting the results of this systematic review. At study level, the quality of the studies
varied. Overall, we found only a small number of relevant studies (n=5). Our findings are
limited due to methodological heterogeneity, small sample sizes of the included studies, lack
of homogeneous group characteristics, differences in intervention components and
outcomes, as well as a variety of instruments used to measure the outcomes. These factors
could have affected the statistical power of the included studies, thus generating inconsistent
results. Another limitation is the insufficient description of all control groups, potentially
preventing an accurate comparison of the intervention and control groups. This indicates the
need for further efforts to close this gap. At review level, we only included English and
German language studies, which may have limited the number of available studies and we
were unable to synthesize study effect sizes due to the range of outcomes reported and
instruments used to determine them. Furthermore, we conducted a comprehensive literature
search including various sources for supplemental study information (trial registries and
Google Scholar), but it is possible that unpublished studies exist and, therefore, we cannot
be certain that we identified all the relevant studies. Finally, we did not employ a health
sciences’ librarian to develop the search strategy for retrieving literature, which might be a
limitation.

30
5.5 Implications for research and practice
Further research is needed to examine which components and content of intervention as well
as which mode of delivery are most effective in providing support to people with dementia
and their informal caregivers during the transition from home care to nursing home care.
Given the fact that no intervention was identified to support people with dementia during the
transition from home care to nursing home care, developing and designing interventions
should be done while taking into account the needs of people with dementia during the
transition period. A current systematic review of qualitative studies by Afram et al. (2015)
focused specifically on the needs of informal caregivers during transition from home towards
institutional care in dementia (Afram et al., 2015). If we are dealing with the question whether
the identified intervention components and contents fit the individual caregivers’ needs and
concerns, the present findings show that specific needs of caregivers - being informed about
available care alternatives, or being informed about financial options or a need for skills in
self-care, such as caring for their own mental and physical health - were not covered by the
interventions. Furthermore, it should be investigated which intervention components are most
effective in which transition period, i.e. prior to, during, and after nursing home placement.
This should also be complemented by qualitative research which helps to develop, test and
refine intervention development iteratively, getting a better understanding of what makes
interventions work. One finding of this review was that counseling and support had been
delivered in several ways by different healthcare professionals across these studies. This
raises the research question about prerequisite competences and professional education. In
general, all interventions included were conducted in the United States. Considering the
generalisability to other countries, it should be taken into account that the transferability of
research results varies across healthcare settings and healthcare cultures.

5.6 Authors' conclusions

We identified a small number of studies (n=5) with differences in the methodological quality
of the studies and heterogeneous outcomes. Evidence exists that psychosocial interventions
improve interactions with staff, and reduce informal caregivers’ depressive symptoms,
burden, emotional distress, overload, chronic grief and feelings of guilt. The studies showed
differences in terms of components, content, mode of delivery as well as long-term and
short-term intervention effects. What is common to all of the studies is that the interventions
were designed to help caregivers cope with the stress and burden. More research is needed
that refers to the MRC guidance for development and evaluation of complex interventions as
well as more well-designed RCTs with larger sample sizes based on a rigorous methodology
to confirm the intervention effects of the trials. There is still not enough evidence for issuing

31
recommendations to implement psychosocial counseling and support interventions in clinical
practice.

Authors’ contributions
All of the authors meet the criteria recommended by the Recommendations for the Conduct,
Reporting, Editing and Publication of Scholarly Work in Medical Journals by the “International
Committee of Medical Journal Editors (ICMJE)” and have agreed on the 2015 version. All of
the authors (CM, SL, AS, and GM) conceptualized, read and approved the final draft of the
manuscript. In detail: CM conducted the literature searches, screened all references in titles,
abstracts and full-texts for relevant studies, conducted quality assessment, data-extraction
and synthesis of the included studies; SL participated in the literature searches, screened all
references in titles, abstracts and full-texts, checked quality assessment and was involved in
interpretation of data; AS was involved in conception and design, particularly in the
development of the analytic strategy, acted to solve any conflict related to the studies’
selection, edited and revised the manuscript for important intellectual content; GM was
involved in conception and study design, acted to solve any conflict related to the studies’
selection, contributed to the analytic strategy, read and approved the first draft of the
manuscript and edited and revised subsequent drafts.

Funding: No external funding.

Conflict of interest: None.

Supplemental data and materials: Appendix 1 to 4

Supplementary data and materials about the search strategy in full detail, the reasons for
exclusion of full-text articles, the theoretical grounding of interventions and quality criteria
fulfillment of included studies associated with this article can be found online at http://XXXXX

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