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JAN

JOURNAL OF ADVANCED NURSING

ORIGINAL RESEARCH

Nurse-led self-management group programme for patients with


congestive heart failure: randomized controlled trial
Esther S.T.F. Smeulders, Jolanda C.M. van Haastregt, Ton Ambergen, Nicole H.K.M. Uszko-Lencer,
Josiane J.J. Janssen-Boyne, Anton P.M. Gorgels, Henri E.J.H. Stoffers,
Cara L.B. Lodewijks-van der Bolt, Jacques Th.M. van Eijk & Gertrudis I.J.M. Kempen
Accepted for publication 5 February 2010

Correspondence to E.S.T.F. Smeulders:


e-mail: g.kempen@zw.unimaas.nl
Esther S.T.F. Smeulders PhD
Policy Maker
Department of Health Care and Nursing
Science, CAPHRI, Maastricht University,
The Netherlands
Jolanda C.M. van Haastregt PhD
Researcher
Department of Health Care and Nursing
Science, CAPHRI, Maastricht University,
The Netherlands
Ton Ambergen PhD
Researcher
Department of Methodology and Statistics,
CAPHRI, Maastricht University,
The Netherlands
Nicole H.K.M. Uszko-Lencer MD
Cardiologist
Department of Cardiology, University
Hospital Maastricht, The Netherlands
Josiane J.J. Janssen-Boyne MA RN
Research Nurse, PhD Student
Department of Cardiology, Integrated Care,
University Hospital Maastricht,
The Netherlands
Anton P.M. Gorgels MD PhD
Cardiologist, Professor of Integrated Care
Department of Cardiology, University
Hospital Maastricht, The Netherlands

continued on page 1488

SMEULDERS E.S.T.F., VAN HAASTREGT J.C.M., AMBERGEN T., USZKO-LENCER N.H.K.M., JANSSEN-BOYNE J.J.J., GORGELS A.P.M., STOFFERS H.E.J.H.,
LODEWIJKS-VAN DER BOLT C.L.B., VAN EIJK J.TH.M. & KEMPEN G.I.J.M.
( 2 0 1 0 ) Nurse-led self-management group programme for patients with congestive
heart failure: randomized controlled trial. Journal of Advanced Nursing 66(7),
14871499.
doi: 10.1111/j.1365-2648.2010.05318.x

Abstract
Title. Nurse-led self-management group programme for patients with congestive
heart failure: randomized controlled trial.
Aim. This paper reports on of the effects of the Chronic Disease Self-Management Programme on psychosocial attributes, self-care behaviour and quality of life among congestive heart failure patients who experienced slight to marked limitation of physical activity.

Background. Most self-management programmes for congestive heart failure patients


emphasize the medical aspects of this chronic condition, without incorporating psychosocial aspects of self-management. The programme has been used with various patient
groups, but its effectiveness with congestive heart failure patients when led by pairs of
cardiac nurse specialists and peer leaders is unknown.

Method. A randomized controlled trial with 12 months of follow-up from start of the
programme was conducted with 317 patients. Control group patients (n = 131) received
usual care, consisting of regular outpatient checkups. Intervention group patients (n = 186)
received usual care and participated in the six-week self-management programme. The
programme teaches patients medical, social and emotional self-management skills.
Twenty-one classes were conducted in six hospitals in the Netherlands, and data were
collected between August 2004 and January 2007.

Results. Directly after the programme, statistically significant effects were found for
cognitive symptom management (P < 0001), self-care behaviour (P = 0008) and cardiacspecific quality of life (P = 0005). No effects were found at 6- and 12-month follow-up.
Conclusion. Further research is necessary to study how long-term effectiveness of the
programme with patients with congestive heart failure can be achieved, and how successful
adaptations of the programme can be integrated into standard care.

Keywords: congestive heart failure, group, nurse-led programme, patients, quality of


life, randomized controlled trial, self-management

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Henri E.J.H. Stoffers MD PhD


General Practitioner, Researcher
Department of General Practice, CAPHRI,
Maastricht University, The Netherlands
Cara L.B. Lodewijks-van der Bolt MD
Cardiologist Department of Cardiology,
Atrium Medical Centre, Heerlen,
The Netherlands
Jacques Th.M. van Eijk PhD
Professor of Social Medicine
Department of Social Medicine, CAPHRI,
Maastricht University, The Netherlands
Gertrudis I.J.M. Kempen PhD
Professor of Social Gerontology
Department of Health Care and Nursing
Science, CAPHRI, Maastricht University,
The Netherlands

Introduction
Ageing of the population in combination with improved
treatment options are fuelling the congestive heart failure
(CHF) epidemic, imposing a significant burden on society
(Mosterd & Hoes 2007, Thomas & Rich 2007). At the
patient level, CHF seriously affects quality of life in terms of
physical, social and emotional functioning and reduces life
expectancy considerably (van Jaarsveld et al. 2001, 2006,
Yu et al. 2008). As CHF touches nearly every important
aspect of daily life, patients are encouraged to take
responsibility for their day-to-day disease management.
Unfortunately, many patients with CHF fail to adhere to
the complex regimen (Riegel & Carlson 2002, van der Wal
& Jaarsma 2008). Furthermore, in addition to dealing with
the medical aspects of CHF, patients face equal difficulties
in dealing with its emotional and social consequences
(Martensson et al. 1997, 1998, Moser 2002, Konstam et al.
2005). Psychosocial factors, however, are infrequently
treated in CHF care, as patients management of the
medical aspects of CHF is mainly emphasized without
addressing social and emotional problems (Moser 2002).
Nurse support for CHF also focuses mainly on these
medical aspects (Jaarsma et al. 2004, 2008, Bruggink-Andre
de la Porte et al. 2005).

Background
In the Chronic Disease Self-Management Programme
(CDSMP) patients are taught to deal with the medical (i.e.
1488

physical), social and emotional consequences of being chronically ill and their responsibility in managing their chronic
condition at all three levels is emphasized (Lorig & Holman
2003). It enables nurses trained with the programme both to
support patients self-management behaviour and to provide
psychosocial care related to managing CHF in daily life. The
CDSMP is a generic cognitive-behavioural group programme
and is underpinned by the assumption that patients with
different chronic diseases can learn from each other as they face
similar adaptive tasks (Lorig et al. 1999). The programme is
based on Banduras self-efficacy theory, in which self-efficacy
refers to the confidence to achieve certain behaviours or
physiological states under specific conditions (Bandura 1997).
Self-efficacy is considered a powerful determinant of behavioural change, as self-efficacy beliefs influence how much effort is
put into changing behaviour and how long people will
persevere in the face of obstacles and failures (Sherer et al.
1982, Bandura 1997). In addition, there are indications that
low levels of self-efficacy predict functional decline among
patients with CHF (Kempen et al. 2000). Previous studies in
the USA have identified statistically significant short- and longterm effects of the CDSMP on outcomes such as self-rated
health, self-efficacy and use of cognitive symptom management
techniques in groups of patients with different chronic conditions (Lorig et al. 1999, 2001a, 2001b). The CDSMP is a
widely disseminated programme within and outside the USA,
and has been used with both heterogeneous and homogeneous
patient groups (Fu et al. 2003, Lorig et al. 2003, 2005a,
2005b, Wright et al. 2003, Farrell et al. 2004, Barlow et al.
2005, Chan et al. 2005, Griffiths et al. 2005, Swerissen
et al. 2006, Elzen et al. 2007, Goeppinger et al. 2007, Kendall
et al. 2007, Kennedy et al. 2007, Siu et al. 2007). However, its
effectiveness and feasibility with patients with CHF in particular have not been assessed.
We expected that patients with CHF would benefit from
this self-management programme as, regarding the medical
(i.e. more physical) consequences of the disease, they face
many challenges in daily physical functioning, in adhering to
a complex regimen and in dealing with end-of-life issues
(Stewart et al. 2001, Willems et al. 2004). In addition, the
CDSMP not only emphasizes the medical aspects of selfmanagement, but also gives patients tools to improve their
social and emotional self-management abilities (Lorig et al.
2001b, Lorig & Holman 2003). Increasing self-management
skills among patients with CHF might positively influence
their self-care behaviour, psychosocial attributes related to
managing their chronic condition (i.e. self-efficacy expectancies, perceived control, and cognitive symptom management)
and health-related quality of life. The CDSMP, led by pairs of
cardiac nurse specialists and peer leaders, was considered

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JAN: ORIGINAL RESEARCH

feasible for patients with CHF in a feasibility study which


was conducted alongside the trial (Smeulders et al. 2009b).

The study
Aim
The aim of the study was to assess the effects of the CDSMP
on psychosocial attributes, self-care behaviour and quality of
life among patients with CHF who experienced slight to
marked limitation of physical activity.

Design
A two-group randomized controlled trial with 12 months of
follow-up from baseline was conducted in six hospitals in the
Netherlands (Smeulders et al. 2006). The hospitals were
comparable in clinical and outpatient care facilities (i.e.
regular checkups with the cardiologist and/or nurse specialist)
for patients with CHF.
Twenty-one CDSMP classes (with parallel control groups)
were conducted in the period from October 2004 to January
2006 in 11 consecutive cycles, with at least one CDSMP class
in each cycle. In each cycle, after completion of baseline
measurements, patients were randomly allocated (per hospital) to the intervention or control group using a computerized
allocation procedure in SPSS 12.0 (SPSS Inc., Chicago, IL,
USA) for Windows by an independent researcher blinded for
patients characteristics. Control patients received usual care,
consisting of regular checkups with the cardiologist and/or
the CHF nurse specialist at an outpatient clinic. Patients
allocated to the intervention group received the 6-week selfmanagement group programme in addition to usual care.
Patients were not blinded to group allocation. For practical
reasons, an unequal randomization ratio was applied during
the recruitment period as in each cycle the time to recruit
patients for the study was limited. As the group process is
very important in the CDSMP, at least eight participants are
required to participate in the classes (Lorig et al. 2001b).
Therefore, based on the total number of recruited patients per
cycle, 59% were allocated to the intervention group and 41%
to the control group through the full recruitment period to
ensure sufficiently large CDSMP classes, taking possible
attrition into account (Dumville et al. 2006).

Participants
Patients who visited the heart failure and/or cardiology
outpatient clinics of the participating hospitals between July
2004 and November 2005 were eligible for the study if they:

Self-management of heart failure

(1) had been diagnosed with CHF based on a systolic


dysfunction (left ventricular ejection fraction (LVEF) <40%,
New York Heart Association (NYHA) Class IIIII) or a
diastolic dysfunction (NYHA Class IIIII), as diagnosed by
the primary cardiologist according to CHF guidelines (Swedberg et al. 2005). Patients with a diastolic dysfunction were
eligible after being admitted at least once to the hospital
based on cardiac decompensation after CHF diagnosis. In
addition, patients were eligible if they: (2) had had an
established CHF diagnosis for at least 6 months at the start of
the intervention period; (3) were able to understand, write
and speak Dutch; and (4) were willing to give informed
consent to participate in the study. Eligible patients received
written information about the study and underwent baseline
assessment after signing the informed consent form. Patients
were excluded if they were participating in other studies.
Sample size estimation was based on figures derived from a
Dutch study with newly diagnosed older patients with CHF
(Kempen et al. 2000) on general self-efficacy expectancies
(Sherer et al. 1982), one of the primary outcome variables in
the present study. To detect a mean difference of at least 40
points in general self-efficacy expectancies scores between the
intervention and control groups (SD = 118; equivalent to an
effect size of 034), a net number of 274 patients needed to be
available for longitudinal analyses to achieve a power of 80%
at an alpha of 005. As we assumed a drop-out rate of 25%
during the trial, a total of approximately 360 patients needed
to be included in the study (Smeulders et al. 2006).

Intervention
The CDSMP is a structured self-management programme
which consists of six weekly group sessions of two and a half
hours each. The programme incorporates four strategies to
enhance self-efficacy expectancies: skills mastery, reinterpretation of symptoms, modelling and social persuasion (Lorig
et al. 1999, 2001a, 2001b, Lorig & Holman 2003). Skills
mastery includes goal-setting and action-planning, which can
be considered as core activities of the CDSMP since they take
up 2535% of each session. Reinterpreting symptoms comprises cognitive symptom management techniques and deals
with relieving symptom problems. By modelling and social
persuasion, either through group participants or leaders,
patients in the class are expected to become motivated to
change their behaviours and beliefs. During the first session,
patients received the reference book Living a healthy life with
chronic conditions (Lorig et al. 2000).
In our study, all CDSMP classes were led by a cardiac nurse
specialist (professional leader) and a patient with CHF
(peer leader), both trained in the CDSMP protocol, instead

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of two trained lay volunteers (who might or who might not


be chronically ill) (Lorig et al. 1999, 2001a). The peer leaders
acted as role models for the other patients in the class.
Cardiac nurse specialists were included to decrease the
potential physical and emotional burden on the peer leaders,
to ensure continuity of the programme and to facilitate
implementation of the CDSMP in standard Dutch health
care. All leaders (n = 18) were trained according to the
CDSMP protocol prior to the intervention period (Smeulders
et al. 2006).

telephone interviews at baseline, directly after the intervention, and 6 and 12 months after the start of the intervention.
Sociodemographics (sex, age, education level, job situation
and living arrangements), NYHA classification, number of
active diseases (CHF and co-morbidities) (Kempen et al.
2000) and cognitive status (Brandt et al. 1988) were
collected at baseline by telephone as background characteristics. Patients who intended to withdraw during the study
were asked to complete at least the last follow-up assessment. Data were collected between August 2004 and January
2007.

Data collection
We assessed effectiveness of the CDSMP on psychosocial
attributes, self-care behaviour and quality of life. Psychosocial attributes measured were general and cardiac-specific
self-efficacy expectancies, perceived control, and cognitive
symptom management. General self-efficacy expectancies
were measured by the General Self-efficacy Scale (GSES)
(Sherer et al. 1982), and cardiac-specific self-efficacy was
measured by the two sub-scales of the Cardiac Self-Efficacy
Questionnaire (Sullivan et al. 1998). Perceived control was
measured by a mastery scale developed by Pearlin and
Schooler (1978). The Coping with Symptoms Scale (Lorig
et al. 1996) was used to measure cognitive symptom
management. This scale was modified by omission of the
first two items and addition of one extra item about the use of
breathing techniques (Elzen et al. 2007). Psychosocial attributes were assumed to be directly influenced by the
intervention (primary outcomes).
Self-care behaviour and quality of life were considered to
be indirectly influenced by the programme (secondary
outcomes). Self-care behaviour was measured with the
European Heart Failure Self-Care Behaviour Scale (EHFScBS)
(Jaarsma et al. 2003). Regarding quality of life, three aspects
were assessed: general and cardiac-specific quality of life,
perceived autonomy, and symptoms of anxiety and feelings of
depression. General quality of life was assessed with the
RAND 36-item Health Survey (RAND-36) (Hays et al.
1993), and cardiac-specific quality of life was measured with
the Kansas City Cardiomyopathy Questionnaire (KCCQ)
(Green et al. 2000). Overall summary scores were obtained
from both scales. Perceived autonomy was assessed by a
visual analogue scale (range 0100) assessing to what extent
the patients were able to arrange their lives in the way they
would like to. Symptoms of anxiety and feelings of depression were measured by the Hospital Anxiety and Depression
Scale (HADS) (Zigmond & Snaith 1983).
Data on the outcome variables were collected confidentially by means of self-administered questionnaires and
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Ethical considerations
Ethics committee approval for conducting this trial was
obtained from a university hospital.

Data analysis
Background characteristics and outcomes at baseline were
compared between the intervention and control groups by
means of chi-square tests, MannWhitney U-tests and t-tests
for independent samples. Differences in outcome variables
were analysed with mixed-effects linear regression models
with the covariance structure unstructured. We examined
between-group differences at the three follow-up assessments
using a mixed-model in which group x time interaction was
included. We adjusted for the baseline score on the outcome
variable and for background characteristics which differed
significantly (P 005) between the intervention and control
groups at baseline. Data were analysed according to the
intention-to-treat principle. If appropriate, effect sizes were
calculated by dividing the difference in mean group scores by
the pooled standard deviation. Effect sizes of 020 were
considered small, 050 medium and 080 large (Cohen 1992).
In addition, pre-planned per-protocol analyses were performed among control and intervention group patients who
attended at least four of the six programme sessions (Smeulders et al. 2006). Missing data were handled according to
scale requirements, except for cardiac-specific self-efficacy
(Sullivan et al. 1998), where we excluded four items owing to
missing values over 25% at baseline measurement. We
therefore computed one overall score for cardiac-specific
self-efficacy. All analyses were based on two-sided tests
(alpha = 005) using SPSS version 12.0.1.

Validity and reliability


To enhance validity and reliability of the data, measures with
good psychometric properties were used. The psychometric

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Self-management of heart failure

trained interviewers blinded to group allocation to enhance


quality of measurement.

properties of the Dutch versions of the GSES, perceived


control scale, HADS and RAND-36 have been shown to be
satisfactory in previous studies (Kempen 1992, van der Zee
& Sanderman 1993, Bosscher et al. 1997, Spinhoven et al.
1997, Kempen et al. 2000, Jaarsma et al. 2003). In addition,
the Cardiac Self-Efficacy Questionnaire and Coping with
Symptoms Scale were previously used in Dutch studies with
older patients with CHF (Arnold et al. 2005a, Elzen et al.
2007). Finally, the telephone interviews were conducted by

Results
Participants and baseline characteristics
A total of 717 patients were eligible for the study, of whom
339 (473%) signed informed consent forms (Figure 1). After

Eligible patients, n = 717

Informed consent, n = 339 (473%)

Not allocated (n = 22)


Incomplete baseline assessment (n = 20)
(health problems, questions too personal)
Died before allocation (n = 1)
Not meeting inclusion criteria (n = 1)

Randomization, n = 317

Allocated to intervention group, n = 186

Refused participation (n = 378)


Physical problems (n = 84)
No interest (n = 74)
No time/opportunity (n = 74)
Psychosocial problems (n = 39)
Problems attending group programme (n = 22)
Cognitive problems (n = 12)
Reason unknown (n = 48)
Other reasons (n = 25)

Allocated to control group, n = 131

6-week group program


Received < 4 sessions (n = 46)
Received 4 sessions (n = 140)

Follow-up
Directly after intervention (n = 175)
6 months after start intervention (n = 164)
12 months after start intervention (n = 156)

Follow-up
Directly after intervention (n = 124)
6 months after start intervention (n = 110)
12 months after start intervention (n = 109)

Lost to follow-up (n = 30)


Death (n = 18)
Health problems (n = 5)
Lost interest (n = 1)
Too challenging (n = 1)
Cognitive problems (n = 2)
Other reasons (n = 3)

Lost to follow-up (n = 22)


Death (n = 12)
Health problems (n = 4)
Lost interest (n = 1)
Too challenging (n = 1)
Other reasons (n = 4)

Completed trial, n = 156

Completed trial, n = 109

Figure 1 Flow of participants through the study.


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completion of the baseline assessment, 186 patients were


allocated to the intervention group and 131 to the control
group. In total, 265 patients (836%) completed the trial
(baseline assessment plus at least the 12-month follow-up
measurement), and these were 156 intervention group
patients (839%) and 109 control patients (832%). As the
recruitment period was limited, the target of 274 patients was
not completely reached (n = 265; 97%). However, the dropout rate was less than expected (Smeulders et al. 2006).
Death was the main reason for lost to follow-up in the
intervention (n = 18) and control groups (n = 12). No
adverse events or side effects were reported during the trial.
The background characteristics were comparable for
intervention and control groups (Table 1). Regarding the
outcome measures, patients in the intervention group scored
significantly lower on cardiac-specific quality of life at
baseline than control patients (Table 3). No other significant
differences were found at baseline.

Outcomes
Regarding psychosocial attributes, a significant short-term
effect of the CDSMP was found for cognitive symptom
management (Table 2). No significant effects were found at 6
and 12 months of follow-up, nor did the CDSMP significantly improve self-efficacy expectancies and perceived control over time. A significant short-term effect of the CDSMP
was found for self-care behaviour, but did not extend to 6
and 12 months of follow-up.
Regarding quality of life, a significant positive short-term
effect was found for cardiac-specific quality of life, which
came close to statistical significance at 6-month follow-up
(Table 3). All (significant) effect sizes were small to

medium (Tables 2 and 3). The CDSMP did not affect


general quality of life, perceived autonomy and symptoms
of anxiety and feelings of depression over time. The
programme outcomes were not affected by hospital effects.
Clustering effects regarding hospital or CDSMP class were
not studied.
The per-protocol analysis (n = 271) showed largely comparable results. We found significant short-term effects of the
CDSMP on cognitive symptom management (means: 76 and
98 respectively; mean difference: 290; 95% CI: 388 to
192; P < 0001; d = 045), self-care behaviour (means:
487 and 499 respectively; mean difference: 147; 95% CI:
259 to 034; P = 0011; d = 018) and cardiac-specific
quality of life (means: 671 and 663 respectively; mean
difference: 431; 95% CI: 724 to 138; P = 0004;
d = 004). The significant effect of the intervention on
cognitive symptom management continued at 6 months
(means: 81 and 91 respectively; mean difference: 017;
95% CI:
245 to
033; P = 0010; d = 018) and
12 months (means: 77 and 87 respectively; mean difference:
096; 95% CI: 243 to 001; P = 0031; d = 019) of
follow-up (not tabulated).

Discussion
Study limitations
To the best of our knowledge, this is the first randomized
controlled trial of the effectiveness of the CDSMP among
patients with CHF. We used a follow-up period of 12 months
from baseline in order to study long-term effectiveness of the
CDSMP among these patients. In addition, data were
analysed with mixed-effects linear regression models using

Table 1 Background characteristics at baseline (n = 317)

Background characteristics
Number male (%)
Mean age in years at time of inclusion (SD )
Number middle educational level (%)*
Number not employed (%)
Number not living alone (%)
Number NYHA-Class II CHF (%)
Mean number of active diseases (SD )
Mean cognitive status (041) (SD )

Control
group (n = 131)

Intervention
group (n = 186)

P value

89
668
90
113
89
91
30
324

141
666
119
169
124
120
30
327

0122
0882
0207
0198
0812
0358
100
0407

(679)
(101)
(687)
(863)
(679)
(695)
(15)
(31)

(758)
(110)
(643)
(909)
(667)
(645)
(16)
(33)

*Middle educational level; attended secondary (vocational) education.


NYHA-Class II CHF; New York Heart Association Class II symptom severity of congestive heart failure.

Underlined scores indicate most favourable scores.


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Self-management of heart failure

Table 2 Effects of the CDSMP on psychosocial attributes and self-care behaviour (n = 317)
Intervention
group, mean (SD )

Adjusted mixed-effects,
mean difference (95% CI)

(113)
(118)
(130)
(116)

552
570
563
579

(117)
(123)
(125)
(129)

(81)
(76)
(68)
(76)

346
368
356
369

(78)
(75)
(85)
(76)

(55)
(49)
(53)
(55)

228
242
239
239

(51)
(57)
(58)
(56)

(45)
(49)
(51)
(51)

72
93
86
83

(47)
(50)
(55)
(55)

(67)
(65)
(65)
(66)

477
498
483
492

(60)
(58)
(65)
(63)

Control group,
mean (SD )
Psychosocial attributes
General self-efficacy (1680)*
Baseline
574
Direct follow-up
576
6-month follow-up
584
12-month follow-up
584
Cardiac self-efficacy (0 to 36)*
Baseline
350
Direct follow-up
371
6-month follow-up
373
12-month follow-up
364
Perceived control (7 to 35)*
Baseline
233
Direct follow-up
242
6-month follow-up
248
12-month follow-up
244
CSM (0 to 25)*
Baseline
78
Direct follow-up
76
6-month follow-up
81
12-month follow-up
77
Self-care behaviour
Self-care behaviour (1260)*
Baseline
483
Direct follow-up
487
6-month follow-up
489
12-month follow-up
492

P value

Effect
size, d

132 ( 305 to 042)


022 ( 210 to 166)
159 ( 359 to 040)

0087
0136
0817
0116

001 ( 142 to 145)


113 ( 048 to 273)
093 ( 250 to 063)

0631
0986
0170
0241

053 ( 152 to 046)


041 ( 067 to 149)
033 ( 073 to 139)

0448
0296
0455
0544

228 ( 323 to 132)


084 ( 186 to 018)
073 ( 189 to 043)

0288
<00001
0106
0215

034

147 ( 255 to 039)


011 ( 128 to 106)
094 ( 223 to 035)

0412
0008
0856
0152

018

*Underlined scores indicate most favourable scores.



CSM: cognitive symptom management.

Mixed-effects linear regression models adjusted for baseline values of each outcome and baseline cardiac-specific quality of life; P values for
baseline stand for comparison of the two study groups at baseline (not analysed with mixed-effects linear regression models); all mean scores are
unadjusted mean scores.

all available data for each patient. However, the study also
had some limitations.
First, the target of 274 patients was not completely reached
(n = 265; 97%) (Figure 1), which slightly decreases the
power of our trial to find long-term effects. It is, however,
unlikely that a sample size of 274 patients would have
substantially changed the outcomes. Furthermore, we lost 52
patients (16%) to follow-up. Although this may threaten the
generalizability of our results, the proportions and reasons
for dropout were similar in the intervention and control
groups.
A second limitation is that we used solely self-report
measures for physical functioning rather than more objective
measures such as the 6-minute walk test (Guyatt 1987).
Outcomes of self-report measures and more objective measures, however, in general show comparable results among

patients with CHF with regard to physical functioning


(Arnold et al. 2005b, Shively et al. 2005).

Programme effectiveness
This trial showed that the CDSMP significantly improved
cognitive symptom management, self-care behaviour and
cardiac-specific quality of life of patients with CHF in the
short term. It did not affect perceived control, perceived
autonomy, and symptoms of anxiety and feelings of depression. In addition, no effects were observed for self-efficacy
expectancies, although this is considered one of the key
mechanisms of the CDSMP (Lorig & Holman 2003). The
outcomes of a previous related study showed that the
CDSMP significantly improved physical activity among
patients with CHF for up to 6 months after start of the

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Table 3 Effects of the Chronic Disease Self-Management Programme on quality of life (n = 317)
Control group,
mean (SD )
G-QoL physical (0100)*
Baseline
357 (99)
Direct follow-up
366 (106)
6-month follow-up
370 (102)
12-month follow-up
384 (100)
G-QoL mental (0 to 100)*
Baseline
472 (111)
Direct follow-up
480 (110)
6-month follow-up
494 (114)
12-month follow-up
487 (113)
C-QoL summary score (0 to 100)*
Baseline
656 (192)
Direct follow-up
671 (194)
6-month follow-up
683 (214)
12-month follow-up
696 (204)
Perceived autonomy (0 to 100)*
Baseline
497 (291)
Direct follow-up
499 (279)
6-month follow-up
521 (294)
12-month follow-up
549 (285)
Symptoms of anxiety (0 to 21)*
Baseline
59 (42)
Direct follow-up
55 (43)
6-month follow-up
56 (45)
12-month follow-up
52 (42)
Symptoms of depression (0 to 21)*
Baseline
56 (39)
Direct follow-up
53 (43)
6-month follow-up
50 (43)
12-month follow-up
48 (45)

Intervention
group, mean (SD )

Adjusted mixed-effects,
mean difference (95% CI)

352
378
374
377

(99)
(106)
(105)
(102)

452
477
469
477

(123)
(114)
(120)
(117)

590
657
648
669

(217)
(217)
(226)
(221)

484
516
512
508

(285)
(257)
(281)
(260)

67
56
60
59

(50)
(46)
(48)
(45)

65
56
61
59

(45)
(43)
(48)
(46)

P value

Effect
size, d

167 ( 335 to 002)


140 ( 323 to 044)
003 ( 195 to 189)

0651
0052
0136
0974

084 ( 283 to 116)


149 ( 059 to 357)
009 ( 230 to 248)

0137
0411
0161
0939

410 ( 695 to 125)


313 ( 629 to 002)
296 ( 668 to 075)

0005
0005
0052
0118

006

180 ( 779 to 418)


047 ( 593 to 687)
394 ( 220 to 1009)

0695
0554
0885
0207

026 ( 045 to 097)


012 ( 083 to 059)
050 ( 127 to 028)

0139
0472
0745
0207

028 ( 094 to 038)


024 ( 094 to 045)
035 ( 116 to 047)

0056
0406
0491
0403

Data were collected in Maastricht between August 2004 and January 2007.
*Underlined scores indicate most favourable scores.

G-QoL/C-QoL: General/Cardiac-specific quality of life.

Mixed-effects linear regression models adjusted for baseline values of each outcome and baseline cardiac-specific quality of life; P values for
baseline stand for comparison of the two study groups at baseline (not analysed with mixed-effects linear regression models); all mean scores are
unadjusted mean scores.

programme; however, the programme did not affect other


health behaviour outcomes (such as smoking or drinking) or
healthcare utilization (Smeulders et al. 2009a). Our results
seem, therefore, less favourable than those in previous
evaluation studies by Lorig et al. (1999, 2001a, 2001b).
However, when we compare our results with those of more
recent studies with the CDSMP, we observe a number of
studies that also found only moderate or no effects at all
(Farrell et al. 2004, Chan et al. 2005, Griffiths et al. 2005,
Lorig et al. 2005a, Elzen et al. 2007, Goeppinger et al. 2007,
Kendall et al. 2007), while several other studies showed more
favourable results (Fu et al. 2003, Lorig et al. 2003, 2005b,
Wright et al. 2003, Barlow et al. 2005, Swerissen et al. 2006,
1494

Kennedy et al. 2007, Siu et al. 2007). None of these studies


were conducted solely with patients with CHF, and so a final
conclusion on the effectiveness of the CDSMP for this type of
patients may not be drawn yet. In addition, in none of these
studies was the programme led by pairs of cardiac nurse
specialists and peer leaders.

Possible explanations
There could be several explanations for the fact that the
effects of the programme were limited and did not last over
time. First, the CDSMP has been evaluated in many different
healthcare settings worldwide, showing inconsistencies in

 2010 The Authors. Journal compilation  2010 Blackwell Publishing Ltd

JAN: ORIGINAL RESEARCH

What is already known about this topic


Most self-management programmes for patients with
congestive heart failure emphasize the medical aspects
of this chronic condition, without incorporating
psychosocial aspects of self-management.
The Chronic Disease Self-Management Programme
focuses on the medical, social and emotional
consequences of being chronically ill and emphasizes
patients responsibility in managing their illness on all
three levels.
The programme has been used with various patient
groups, but its effectiveness with patients with
congestive heart failure when led by pairs of cardiac
nurse specialists and peer leaders is unknown.

What this paper adds


The Chronic Disease Self-Management Programme
improved short-term self-care behaviour,
cardiac-specific quality of life and cognitive symptom
management among patients with congestive heart
failure, but no long-term effects were found.
Achieving long-term behavioural change in
self-management programmes for congestive heart
failure patients may be challenging, as patients
constantly need to adapt to a condition which
deteriorates progressively.
The effectiveness of self-management programmes
strongly depends on the level of standard care and the
organization of the healthcare setting in which the
programme is implemented.

Implications for practice and/or policy


The Chronic Disease Self-Management Programme in
its current form is not recommended for large groups of
patients with congestive heart failure.
Assessing the effectiveness of adding booster group
sessions or individual follow-up to the programme is
necessary to study how this affects long-term
effectiveness among patients with congestive heart
failure.
programme effectiveness throughout these studies (Fu et al.
2003, Lorig et al. 2003, 2005a, 2005b, Wright et al. 2003,
Farrell et al. 2004, Barlow et al. 2005, Chan et al. 2005,
Griffiths et al. 2005, Swerissen et al. 2006, Elzen et al. 2007,
Goeppinger et al. 2007, Kendall et al. 2007, Kennedy et al.
2007, Siu et al. 2007). This may indicate that the effective-

Self-management of heart failure

ness of the programme depends on the organization of the


healthcare setting in which it is implemented. Standard care
for patients with CHF in the Netherlands is at a relatively
high level. Nowadays the majority of Dutch hospitals have
their own CHF management programmes, often organized as
outpatient clinics, where patients visit CHF nurse specialists
on a regular basis (Jaarsma et al. 2005). Furthermore, nearly
all people in the Netherlands are covered by healthcare
insurance and are able to consult their own general practitioners. For chronically ill people, health care is relatively
easily accessible and its quality is often considered good
(Elzen et al. 2007). The contrast between our intervention
and Dutch standard care is therefore possibly too small for
the detection of substantial effects. This may also explain the
fact that in another Dutch study evaluating the CDSMP, no
significant effects of the CDSMP were observed on selfefficacy, self-management behaviour, or health status in a
heterogeneous patient group with chronic illnesses (Elzen
et al. 2007).
Second, the programme may be too short or not substantial
enough to achieve long-term behavioural change among
patients with CHF. These patients are often faced with taking
multiple medications and adhering to non-pharmacological
management strategies, which is considered rather challenging (van der Wal & Jaarsma 2008). Furthermore, they need
to constantly adapt to their condition as it progressively
deteriorates. For these reasons it may be important to
increase the time-span of the programme, for example by
adding booster group sessions or individual (telephone-based)
follow-ups. This assumption is supported by the fact that in
another behavioural self-management programme with
patients with CHF, in which group sessions and motivational
phone calls were performed over a longer time-span
(15 weeks), the physical dimension of quality of life was
improved in the long term (Shively et al. 2005). This
programme, however, did not affect emotional quality of
life (Shively et al. 2005). Increasing the time-span is also
supported by the fact that the feasibility study performed
alongside our trial revealed that both participants and leaders
recommended extending the programme, particularly for
issues related to regimen-adherence and end-of-life issues
(Smeulders et al. 2009b).
Third, differences between our results and others may be
partly explained by differences in outcome measures. However, the toolkit currently available through the Stanford
website (http://patienteducation.stanford.edu/) and frequently used was not available when we prepared our study.
Furthermore, we chose validated, partly CHF-specific and
largely internationally published measures for which Dutch
translations were available.

 2010 The Authors. Journal compilation  2010 Blackwell Publishing Ltd

1495

E.S.T.F. Smeulders et al.

Hospital Helmond for their efforts in enabling this study


to be conducted.

Conclusion
Based on the findings of the study, implementation of the
CDSMP in its current form is not recommended among
large groups of patients with CHF. However, the effectiveness of the programme with patients with CHF might be
improved by adapting the format. Adaptations which could
be considered are the addition of booster group sessions or
individual follow-ups, possibly integrated into standard
care, to allow patients to set new goals for behavioural
change. Booster group sessions might be useful for exchanging personal experiences over a longer period and reinforcing the main self-management skills of the CDSMP (e.g.
action-planning). Individual follow-ups might be particularly useful to coach patients to adhere to long-term
behavioural change (e.g. in lifestyle) (Smeulders et al.
2009a) and to address their personal challenges at a
psychosocial level. Future research is necessary to study
how these improvements affect long-term effectiveness
among patients with CHF.
Our study contributes to knowledge with respect to
behavioural change among patients with CHF. We evaluated
a cognitive-behavioural self-management programme that
has shown effectiveness in the USA. In our study, this
programme was considered feasible by both programme
leaders and participants (Smeulders et al. 2009b), but showed
limited, mainly short-term effects (Smeulders et al. 2009a).
This stresses the challenge of achieving long-term behavioural
change among patients with CHF, particularly regarding
psychosocial, more adaptive outcomes such as symptoms of
anxiety and feelings of depression, self-efficacy expectancies,
and quality of life. More effective alternatives need to be
found in nursing care to support self-management behaviour
by patients with CHF, including providing psychosocial care
on managing the condition.

Acknowledgements
This research was conducted within the School for Public
Health and Primary Care: CAPHRI of Maastricht University. We thank N. Steverink, H.A. Elzen, and J.P. Slaets from
the University Medical Center Groningen for their willingness to share Dutch intervention materials. The Centre for
Data and Information Management (MEMIC), L. van Hoef
and V. Schaffers are acknowledged for their assistance in
developing the study materials and in the data collection.
Finally, we want to thank all patients and practitioners of
the University Hospital Maastricht, Atrium Medical Centre
Heerlen, VieCuri Medical Centre Venlo, Laurentius Hospital
Roermond, Orbis Medical Centre Sittard and Elkerliek
1496

Funding
This research was funded by the Netherlands Heart Foundation (2002B005) and the University Hospital Maastricht (PF
179).

Conflict of interest
No conflict of interest has been declared by the authors.

Author contributions
ES, JH, NU, AG, JE and GK were responsible for the study
conception and design. ES performed the data collection. ES
and TA performed the data analysis. ES was responsible for
the drafting of the manuscript. JH, TA, NU, JJ, AG, HS, CL,
JE and GK made critical revisions to the paper for important
intellectual content. TA provided statistical expertise. JE and
GK obtained funding. JH, JE and GK supervised the study.
NU, JJ, AG, HS and CL provided other contributions.

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