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ORIGINAL RESEARCH
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.
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.
1487
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
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:
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
1489
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
1490
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.
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
Randomization, n = 317
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)
1491
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
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
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)
1492
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
0087
0136
0817
0116
0631
0986
0170
0241
0448
0296
0455
0544
0288
<00001
0106
0215
034
0412
0008
0856
0152
018
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
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
0651
0052
0136
0974
0137
0411
0161
0939
0005
0005
0052
0118
006
0695
0554
0885
0207
0139
0472
0745
0207
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.
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
1495
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
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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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