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original research
ABSTRACT
Objective: The goal of this randomized, controlled trial was
RSUM
Objectif : Cet essai contrl avec rpartition alatoire avait
pour objet de comparer lefficacit, aprs six mois, dun programme dducation sur le diabte un modle associant ce
programme un programme dautogestion.
INTRODUCTION
The United States (US) national standards for diabetes
self-management education (1) and the Canadian Diabetes
Association 2008 clinical practice guidelines (2) provide a
comprehensive description of the evidence-based education
that is effective for improving clinical outcomes and quality
Address for correspondence: Dr. Patrick McGowan, 4907 Chisholm Street, Suite 210
Delta, British Columbia, Canada. V4K 2K6, E-mail: mcgowan@dccnet.com
CANADIAN JOURNAL OF DIABETES. 2011;35(1):46-53.
of life for people with diabetes. Education that couples diabetes disease management with behavioural strategiesnamely the use of action plans and problem solvinghas been
shown to bring about improved outcomes (3). Therefore,
the standards and guidelines strongly specify that education
should be interactive and presented in behavioural terms
to exemplify the importance of action-oriented behavioural
goals and objectives, and that goal setting, action planning/
follow-up and problem-solving skills are effective strategies. The International Diabetes Federation has formulated
a strong position statement on diabetes self-management,
advocating that people with diabetes need to understand
the nature of their illness; identify emerging health problems
at early, reversible stages; adhere to self-care practices; and
make needed changes to their health habits (4).
The standards and guidelines are consistent with the
literature advocating the involvement of registered nurses,
dietitians and pharmacists as key primary educators, but
they also cite literature supporting the involvement of lay
health and community workers and peers in providing
information and behavioural support (5). The goal of this
randomized, controlled trial was to compare the 6-month
efficacy of didactic diabetes patient education that focused
on disease management to the same program augmented
by participation in a community peer-led self-management
program that taught and reinforced the use of action planning, follow-up and problem solving.
METHODS
The standard protocol for diabetes care in British Columbia,
Canada, is that adults diagnosed with type 2 diabetes are
referred to a diabetes education centre. Between April 2004
and December 2006, all persons referred to the diabetes
education centre at Richmond Hospital, Richmond, British
Columbia (approximately 1400 in total) were informed
about this study. Diabetes education centre staff explained
the purpose and process of the study, and inquired about
patients interest in participating. The majority of adults
(n=1079) indicated they were too busy to participate in a
study that involved additional diabetes education. Those
who were interested (n=321) were given a copy of the study
consent form, which they reviewed with a staff member,
and provided their signature. Ethical approval for this project was obtained from the University of Victoria Human
Research Ethics Committee and Richmond Health Services
Delivery Area Research Advisory Committee.
Diabetes education staff made arrangements with the
laboratory to obtain metabolic data (glycated hemoglobin
[A1C], high-density lipoprotein cholesterol [HDL-C] and
low-density lipoprotein cholesterol [LDL-C]) and recorded
patients self-reported weights. Patients then completed 2
self-administered questionnaires. The first questionnaire
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RESULTS
In total, 321 people registered in the study; 169 were randomly assigned to the experimental group, and 152 to the
control group. Of the 169 subjects randomly assigned to
the experimental group, only 82 (49%) agreed to take the
community CDSMP after receiving diabetes patient education, even though they had all agreed to so when they
registered in the study. The main reasons provided for not
wanting to take the community CDSMP were as follows:
not able to take time off work (n=19), not having transportation to travel to the program location (n=6), not feeling
comfortable with the English language (n=12) and not being
Baseline comparisons
Table 1 shows demographics and key baseline measures
for subjects in the control group and 2 subgroups of the
assigned experimental group (attendees and non-attendees).
Subjects in the control and experimental groups (attendees)
were similar with respect to age, sex, education, ethnic origin, marital status, time since diagnosis, height, lipid profile
and presence of other health conditions. Subjects in the
control group were heavier (83 vs. 80 kg) and had higher
A1C levels (7.1 vs. 6.8%) than those in the experimental
group (attendees).
Table 1. Baseline characteristics of subjects in the experimental, control and no course groups
Experimental group
(n=82)
Control group
(n=152)
No-course group
(assigned to experimental group)
(n=87)
Age, y
55 (12)
59 (12)
55 (11)
Sex, %
Female
Male
54
46
55
45
40
60
Education, y
14 (4)
14 (3)
14 (3)
Ethnic origin, %
English
Chinese
Filipino
51
15
7
54
9
9
36
12
12
Married/partner, %
71
72
77
2.8 (4.6)
2.8 (5.2)
3.4 (4.9)
Height, cm
168 (10)
170 (20)
170 (13)
Weight, kg
80 (15)
83 (19)
85 (22)
A1C, %
6.8 (1.2)
7.1 (1.5)
7.5 (1.5)
HDL-C, mmol/L
1.19 (0.74)
1.15 (0.35)
1.01 (0.34)
LDL-C, mmol/L
2.81 (1.11)
2.79 (0.81)
2.79 (0.79)
Other conditions, %
Heart
Hypertension
Lung
9
55
5
11
49
5
9
40
3
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Table 2. Pre- and 6-month-postprogram means and significance, and 6-month change means and significance
Experimental (n=82)
Preprogram,
mean (SD)
Postprogram,
mean (SD)
Self-rated health
(15)
2.82 (0.81)
Health distress
(05)
Control (n=152)
Experimental
Control
6-month
change,
mean (SD)
p value
p value
Preprogram,
mean (SD)
Postprogram,
mean (SD)
p value
6-month
change,
mean (SD)
2.50 (0.89)
<0.01
2.85 (0.92)
3.01 (0.89)
0.07
0.32 (0.82)
0.17 (0.85)
<0.01
1.69 (1.29)
1.35 (1.0)
<0.01
1.51 (1.24)
1.46 (1.23)
0.66
0.34 (0.99)
0.05 (0.99)
0.05
Social/role activity
limitations (04)
0.70 (1.03)
0.62 (0.86)
0.44
0.68 (0.97)
0.80 (1.05)
0.17
0.08 (0.95)
0.13 (0.88)
0.13
Fatigue (010)
4.09 (2.79)
3.50 (2.50)
0.02
4.15 (2.45)
4.16 (2.50)
0.97
0.59 (0.23)
0.01 (2.3)
0.09
Shortness of breath
(010)
1.57 (2.19)
1.17 (1.81)
0.04
2.11 (2.57)
2.06 (2.37)
0.86
0.40 (1.68)
0.04 (2.37)
0.26
Pain (010)
2.82 (2.94)
2.58 (2.46)
0.39
3.17 (2.92)
3.38 (2.83)
0.43
0.23 (2.37)
0.21 (2.58)
0.24
Outcome
measure*
Health status
Self-management behaviours
Communication with
doctor (05)
2.62 (1.12)
2.96 (1.07)
<0.01
2.40 (1.02)
2.26 (1.12)
0.27
0.34 (1.05)
0.14 (1.16)
0.01
0.99 (1.20)
1.12 (1.04)
0.35
0.96 (1.17)
1.04 (1.18)
0.61
0.14 (1.25)
0.07 (1.27)
0.75
0.50 (1.18)
0.72 (0.41)
0.14
0.75 (0.61)
0.74 (0.58)
0.91
0.22 (0.58)
0.01 (0.66)
0.91
Times practiced
relaxation in last
week
0.40 (1.23)
1.08 (2.32)
0.01
0.98 (2.40)
0.94 (2.18)
0.91
0.68 (2.35)
0.03 (2.68)
0.07
Self-efficacy to
manage symptoms
(110)
7.12 (2.51)
7.66 (2.39)
0.03
6.95 (2.86)
7.04 (2.73)
0.78
0.54 (2.12)
0.09 (3.00)
0.03
Self-efficacy to
manage disease in
general (110)
7.11 (2.87)
7.54 (2.79)
0.11
7.03 (2.79)
7.21 (2.78)
0.55
0.43 (2.33)
0.18 (2.89)
0.54
6.8 (1.2)
6.4 (0.6)
<0.01
7.1 (1.5)
6.7 (1.0)
0.01
0.50 (0.80)
0.40 (1.30)
0.93
HDL-C, mmol/L
1.24 (0.83)
1.20 (0.35)
0.70
1.15 (0.35)
1.18 (0.37)
0.21
0.04 (0.81)
0.03 (0.19)
0.48
LDL-C, mmol/L
2.66 (0.99)
2.74 (0.88)
0.38
2.76 (0.71)
2.58 (0.81)
0.62
0.08 (0.64)
0.18 (0.79)
0.35
Weight, kg
80.5 (15.3)
78.1 (15.1)
<0.01
83.0 (18.0)
80.0 (17.4)
<0.01
2.40 (5.13)
3.00 (4.8)
0.50
Self-efficacy
Laboratory tests
A1C, %
Diabetes empowerment
Setting and achieving
goals (15)
3.94 (0.55)
4.14 (0.47)
<0.01
3.96 (0.56)
3.88 (0.68)
0.24
0.20 (0.49)
0.08 (0.64)
<0.01
Managing psychosocial
aspects (15)
3.78 (0.67)
4.02 (0.57)
<0.01
3.85 (0.61)
3.82 (0.69)
0.73
0.24 (0.61)
0.03 (0.73)
0.02
Assessing readiness
to change (15)
3.77 (0.46)
4.05 (0.49)
<0.01
3.81 (0.53)
3.76 (0.53)
0.48
0.30 (0.53)
0.05 (0.61)
<0.01
Paired t-tests were used to compare pre-program vs. post-program in each group
2-sample t-tests were used to compare the 2 groups with respect to 6-month change
Table 3. Pre- and 6-month-postprogram means and significance, and 6-month change means and significance
for healthcare utilization
Experimental
(n=75)
Healthcare
utilization in
last 6 months
Preprogram,
mean (SD)
Control
(n=90)
PrePostprogram,
program,
mean (SD) p value* mean (SD)
Experimental
6-month
Postchange,
program,
mean (SD) p value* mean (SD)
Control
6-month
change,
mean (SD) p value p value
Number of doctor
visits
3.20
(2.09)
2.35
(2.30)
0.002
3.34
(2.37)
2.62
(2.31)
0.007
0.85
(2.25)
0.72
(2.52)
0.74
0.63
Number of visits to
emergency room
0.15
(0.49)
0.07
(0.38)
0.28
0.17
(0.48)
0.18
(0.61)
0.88
0.08
(0.63)
0.01
(0.70)
0.38
0.48
Number of times
hospitalized for
1 night or longer
0.05
(0.28)
0.01
(0.12)
0.26
0.04
(0.21)
0.10
(0.34)
0.13
0.04
(0.31)
0.06
(0.35)
0.065
0.09
Total number of
nights spent in
hospital
0.40
(1.99)
0.17
(1.39)
0.32
0.10
(0.50)
0.48
(2.17)
0.08
0.23
(1.94)
0.38
(2.03)
0.054
0.083
Intent-to-treat analysis
A similar set of analyses (2-sample t-tests, Mann-Whitney,
ANCOVA) was carried out to compare the intent-to-treat
experimental and control groups. There was a statistically
significant change (p=0.008) with respect to assessing readiness to change subscale of the Diabetes Empowerment Scale;
mean change in the experimental group was 0.183 (SD 0.61)
and in the control group was 0.045 (SD 0.61).
Comparison of 12-month changes
An attempt was made to follow subjects beyond the
6-month-postprogram period, but diabetes education centre staff were able to convince only a subset of subjects in
both groups to return for repeated tests. In total, 12-month
post-program A1C measures and weights were obtained for
40 and 51 subjects of the experimental group (attendees),
and 55 and 88 subjects of the control group, respectively.
At 12 months, experimental group subjects scores were
statistically lower than at baseline for both A1C (6.4 vs.
6.8%) and weight (79.2 vs. 80.0 kg), respectively. Mean
weight in the control group was still lower than at baseline
(78.5 vs. 83.0 kg), while mean A1C had risen from 7.1%
at baseline to 10.6% at 12 months. However, because the
samples were not random and sizes were small, one cannot
draw inferences. A longer-term (i.e. 12 to 36 month) randomized, controlled trial would provide stronger evidence
regarding the sustainability of changes.
DISCUSSION
This study compared the efficacy of a didactic model of
diabetes patient education provided at a diabetes education centre in British Columbia, Canada, to that of a model
that combined diabetes patient education with a community self-management program. Results showed that at 6
months post-program, subjects in both the experimental
and control groups had made improvements in key diabetes measures, namely A1C level and weight. Adjustment
for baseline A1C levels and weight did not account for the
differences between experimental and control groups. The
analysis found that for 4 outcome measures, the experimental group had statistically greater pre/post changes at 6
months than the control group. The intent-to-treat analysis
found 1 statistically significant change between the groups.
This was to be expected, since only about half of the experimental group subjects actually received the intervention;
including these subjects in the analysis resulted in a diluting
of the effect of the add on CDSMP.
The major significance of this study is that a non
disease-specific self-management intervention that taught
subjects to use action plans and the problem-solving
process was effective in bringing about improvements in
a few outcome measures, over and above the effectiveness
of didactic diabetes education that focused on disease
management. While new Canadian, US and international
guidelines encourage diabetes educators to incorporate
self-management support strategies into patient education
CANADIAN JOURNAL OF DIABETES. 2011;35(1):46-53.
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CONCLUSION
A subset of patients receiving diabetes patient education
agreed to also participate in a 6-week community selfmanagement program. By examining pre- and post-program
changes in self-report and biometric disease measures the
findings suggest incorporating a low-cost community selfmanagement program into routine diabetes care can bring
about additional patient improvements. The community
lay-led self-management program provided support for the
clinical services delivered by diabetes health professionals
and should be considered an adjunct to usual care.
ACKNOWLEDGMENTS
I would like to thank project advisory committee members
of Richmond Hospital (Moira Bradshaw BSc, Ann Dauphinee
MScN, Barbara Leslie BA, James Lu MD MHSc and Suman
Prasad RN), Fran Hensen RN BScN Med, Sherry Lynch
MSW, for project coordination and Jonathan Berkowitz PhD
for expertise in data analysis and presentation.
AUTHOR DISCLOSURES
This research was supported by a grant from the Vancouver
Foundation (BCM03-0095). Parts of this study were orally
presented at the Showcase of Research in Aging, University
of Victoria, Victoria, British Columbia, Canada, on June 20,
2007; and at the Taking Charge of Our Health, Canadian
Conference on Integrated Chronic Disease Self-Management,
Toronto, Ontario, Canada, on October 23, 2008.
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self-management education. Diabetes Care. 2009;32(suppl 1):S87-S94.
2. Canadian Diabetes Association Clinical Practice Guidelines Expert
Committee. Canadian Diabetes Association 2008 clinical practice
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