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Elham Shakibazadeh, Leona Kay Bartholomew, Arash Rashidian, Bagher Larijani, Persian Diabetes Self-Management Education (PDSME) program: evaluation of effectiveness in Iran, Health Promotion International, Volume 31, Issue 3, September 2016, Pages 623–634, https://doi.org/10.1093/heapro/dav006
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Abstract
Despite increasing rate of diabetes, no standard self-management education protocol has been developed in Iran. We designed Persian Diabetes Self-Management Education (PDSME) program using intervention mapping. Effectiveness of program was assessed in newly diagnosed people with type 2 diabetes and those who had received little self-management education. Individuals aged 18 and older (n = 350) were recruited in this prospective controlled trial during 2009–2011 in Tehran, Iran. Patients were excluded if they were pregnant, were housebound or had reduced cognitive ability. Participants were randomly allocated in intervention and control groups. PDSME patients attended eight workshops over 4-week period following two follow-up sessions. Validated questionnaires assessed cognitive outcomes at baseline, 2 and 8 weeks. HbA1c was assessed before and 18–21 months after intervention in both groups. The CONSORT statement was adhered to where possible. A total of 280 individuals (80%) attended the program. By 18–21 months, the PDSME group showed significant improvements in mean HbA1c (−1.1 versus +0.2%, p =0.008, repeated measure ANOVA (RMA)). Diabetes knowledge improved more in PDSME patients treated with oral antidiabetic agents than in those receiving usual care over time (RMA, F = 67.08, p < 0.001). Statistically significant improvements were seen in PDSME patients for self-care behaviors, health beliefs, attitudes toward diabetes, stigma, self-efficacy and patient satisfaction. PDSME program was effective in improving self-management cognitive and clinical outcomes. Results support use of intervention mapping for planning effective interventions. Given the large number of people with diabetes and lack of affordable diabetes education, PDSME deserves consideration for implementation.
INTRODUCTION
In the past, diabetes education has been focused chiefly on presenting medical facts about the disease to patients. This approach has not been effective in helping people with diabetes to manage the disease and improve outcomes (Adolfsson et al., 2007). In recent years, several successful educational programs have focused on empowerment of patients through enhancing their knowledge, skills and attitudes necessary to influence their own behavior.
However, research studies have shown that many diabetes self-care education programs are not effective (Weiner et al., 1995). Few educational programs in diabetes management have used constructs from various health behavior theories to guide development of programs. In most reports of educational programs, there are no detailed explanations of how programs are designed and developed. Importantly, in area of cultural sensitivity, program developers often do not describe formative research or explain how program addresses cultural needs. In addition, the basis for selection of intervention methods is usually unclear or not reported.
Overall assessments of effectiveness of patient education programs for diabetes presented in systematic reviews suggested that quality of reporting and methodology was generally found to be poor by today's standards. Interestingly, studies of lower quality [as rated by reviewers based on Cochrane methodology (Clarke and Oxman, 2000) for four types of bias (Norris et al., 2001)] reported more significant effects from self-management training (Loveman et al., 2003; Steed et al., 2003).
There are limited educational programs available in Iran for patients with type 2 diabetes (from here on referred to as diabetes). Culturally sensitive health education programs may positively influence health behavior in individuals (Nicolaou et al., 2013). Qualitative studies have shown that educational barriers are among the main perceived barriers for patients with diabetes (Shakibazadeh et al., 2011). In a systematic review published about educational interventions on Iranian patients with diabetes, authors (Baradaran et al., 2010) were unable to reach firm conclusions regarding the effectiveness of diabetes education in Iran due to evidence that was both conflicting and insufficient. We have designed a comprehensive program entitled Persian Diabetes Self-Management Education (PDSME) for patients with diabetes using intervention mapping (Bartholomew et al., 2000; Bartholomew et al., 2006). This study evaluates effectiveness of the program compared with a usual-care control group at 2 weeks, 8 weeks and 18–21 months.
METHODS
Developing PDSME program
Intervention mapping introduces step-by-step guidance for planning theory- and evidence-based health education programs. As the first step, the team conducted needs assessment studies [qualitative studies (Shakibazadeh et al., 2009; Shakibazadeh et al., 2011) and a survey (unpublished) of different stakeholder groups]. The team conducted the remaining five steps of intervention mapping (i.e. writing performance objectives, determining methods and strategies, designing educational materials, developing dissemination of program plan, developing a monitoring and evaluation plan) in close collaboration with other health professionals involved in the care of diabetes patients. As recommended by Bartholomew et al. (Bartholomew et al., 2006), the entire process of intervention mapping was informed by relevant theories of behavior change that have been shown to be effective in diabetes care: adult learning theory (Knowles, 1973), health belief model (Champion and Skinner, 2008) and social cognitive theory (Sallis et al., 2008).
The intervention
The PDSME comprises eight 2½-h educational workshops offered over a 4-week period and followed by two ‘booster’ sessions, each 2 weeks apart. A nurse educator, dietitian and counselor conducted the program in an outpatient diabetes clinic in Tehran, and an average of 20–25 participants attended each session. We provided a modified version of the curriculum of American Association of Diabetes Education based on its seven areas of diabetes self-management including (i) healthy eating, (ii) being active, (iii) monitoring blood glucose, (iv) taking medication, (v) problem solving, (vi) reducing risks and (vii) healthy coping. The modifications were based on the certain patients' barriers that emerged during the qualitative interviews (Shakibazadeh et al., 2011). For instance, we found in the qualitative study that many patients were disappointed not to be able to control their disease; and they complained of the lack of adequate family support. We set up group-based classes and invited a family member to enhance the self-efficacy of the patients and improve family support. Educators were responsive to priorities of the group and ensured that key contents based on the curriculum were included. All sessions were highly interactive along with group work activities with participants sharing their particular concerns, barriers and progress. Moreover we used visual aids; and set goals for each patient.
The sequence of the program sessions were as follows: (i) assessment of diabetes self-care behaviors and exploration of participant motivation and obstacles for change; (ii) active learning of diabetes topics; (iii) setting feasible goals for behavior change: participants set ‘SMART’ goals (i.e. specific, measurable, achievable, realistic and time-honored (Shrewsbury et al., 2009); (iv) answering clinical questions to present information about diabetes and self-management and (v) two follow-up sessions: the team used motivational interviewing strategies (Rollnick et al., 2008) to support and reinforce maintenance of behavior change.
Control group patients had the opportunity of attending clinic's usual 30-min lecture-based non-interactive educational sessions. The educational materials included pamphlets with limited topics on the definition of the diabetes, foot-care, diet and exercise provided by the Iranian Diabetes Society that were given to the patients at the end of the class.
Educational materials
Educational materials for the program included a protocol for use by the program team to manage sessions and a package of patient materials including (i) forms for assessment, goal setting, blood glucose monitoring and ‘pros and cons’ exercise; (ii) information brochures and quick reference pamphlets on diabetes care and (iii) patient's HbA1c test results letter.
Participants
The study team extended a telephone invitation to 350 individuals with diabetes who were registered with the Charity Foundation for Special Diseases' diabetes clinic. This large team-based clinic provides care by nurse educators, dietitians and endocrinologists to ∼6500 registered diabetic patients. We selected the 350 patients among those most recently registered with the clinic and all those who met the inclusion criteria were sent the invitation letters.
The inclusion criteria for participant selection were: diagnosed with diabetes [according to the WHO criteria; WHO Working Group, 1999) by their physicians, not having participated in other diabetes intervention studies; and older than 18 years. Individuals were excluded if they were pregnant, were unable to participate in a group program or had reduced cognitive ability. The team verified willing respondents for eligibility and obtained written informed consents.
Allocation procedures
The team received a list of registered patients from the clinic. This list had been prepared by the clinic based on registration order of patients with clinic, and no other factor had contributed to patients’ order on the list. Each patient on the list was assigned a consecutive research identification number according to the order by which they were registered with the clinic. The first patient on the list was randomly assigned to the intervention group, and the next patient was assigned to the control group. The procedure was continued so that the patients with odd and even numbers were assigned to the intervention and control groups, respectively. The patients on the list from the first person onward were contacted one by one until the target number of participants had been recruited (n = 140 per group; Figure 1). The allocation was done by a diabetes clinic nurse who was not aware of the study objectives; so it was blinded to the project's coordinator and the research team.
Data collection
First, baseline measurements were assessed after the patients had agreed to participate. The immediate intervention effects on diabetes knowledge, self-care activities and psychological outcomes were measured at 2 weeks and stabilization of these effects was assessed 8 weeks after the intervention. The clinical outcome was measured 18–21 months later. If participants failed to attend one session, they received a telephone reminder. If they failed to attend two sessions, no further contact was made during the program. The control group was seen in their usual diabetes clinic in addition to their study appointments (which were only for data collection).
Measures
Outcome measures included diabetes knowledge, self-care activities, psychological and clinical outcomes. Diabetes knowledge was measured using the Brief Diabetes Knowledge Test (14 questions for patients treated with oral antidiabetic agents, and 9 further questions for insulin users; Fitzgerald et al., 1998). The ‘Summary of Diabetes Self-Care Activities Measure’ scale was used to assess participants' frequency (over past 7 days) of engaging in diabetes self-care behaviors including diet, exercise, blood glucose testing, foot-care and smoking status (Toobert et al., 2000). Adhering to diet is categorized as general diet (mean number of days for items 1 and 2 of the scale; or specific diet (mean number of days for items 3, and 4, reversing item 4 of the scale). For psychosocial outcomes, validated questionnaires assessed patients’ health beliefs by Brown's health beliefs instrument (Brown et al., 2002); patients’ attitudes toward diabetes using Diabetes Care Profile's positive and negative attitudes sub-scale (Fitzgerald et al., 1996); stigma using five questions from the Illness Perception Questionnaire (Winman, 1996); patient satisfaction by the NCQA/ADA Provider Recognition Program (Joyner et al., 1997); depression by National Depression Screening Day Scale (HANDS) (Baer et al., 2000) and self-efficacy by Diabetes Empowerment Scale (DES-SF) (Anderson et al., 2003). Questionnaires were completed in a designated private area at the clinic, which was staffed by one of the researchers who was available to answer questions if necessary.
The team translated all instruments into Persian using processes of translation and back translation procedure (Wantana and Jane, 2004). We then pilot-tested whether translated versions were easy to comprehend by patients; and conducted content validation (Lynn, 1986) by six specialists in areas of knowledge of instruments. We examined reliability of the instruments through evaluating internal consistency. The Chronbach's alphas for all instruments were >0.7. Persian versions of the questionnaires are available via the first author.
Ethical considerations
Endocrine and Metabolism Research Center's ethics committee approved aims and procedures of this study (E-0083). Written permissions via e-mail were obtained from the authors of the instruments to use them in the study. All patients were informed about the study and purposes and were ensured that all information collected will remain confidential. Every participant signed an informed consent form.
Statistical analysis
A two-sided significance level of 5% was used for statistical inferences. Chi-squared and independent sample t-test were used to assess group equivalency at baseline. Two groups were compared by testing group by time interaction term from a repeated measures analysis of variance. If overall F was significant, Bonferroni pairwise comparisons as post-hoc test were used to find differences between pairs of scores. There were few cases where one or two variables were missing from a completed questionnaire (in total occurred in less than 10 questionnaires). Such missing variables were mean replaced. There were also cases that were missed to follow-up due to attrition. Such cases were not replaced by the mean values. As a sensitivity analysis, we conducted a ‘per protocol’ analysis on those patients who completed the follow-ups.
RESULTS
Sample characteristics and group comparisons at baseline, and at follow-up
Eighty percent of those contacted agreed to participate in the study. Among those who did not participate, 65 patients said that they were not interested or had no time; and 5 patients agreed to participate in the study on telephone call, but did not attend the clinic. In addition, 104 patients dropped out of the study.
Baseline assessments were carried out for all 280 participants. The mean age of the participants at recruitment was 57.7 years (SD = 8.2, range 34–75) and there were more women than men in the study, 164 (58.5%) versus 116 (41.5%), respectively. Over 40% of the participants had lived with diabetes for 5–9 years. A total of 211 (75.3%) participants were treated with tablets, and 69 (24.6%) with insulin. Table 1 compares characteristics of the participants and outcome measures between participants in both groups at baseline. We observed no statistically significant differences between the intervention and control groups for demographic or outcome variables at baseline, indicating that the allocation procedure has been effective.
Variable . | Intervention group (n = 140) . | Control group (n = 140) . | p Value . |
---|---|---|---|
Age (years): mean (SD) | 58.0 (8.1) | 57.4 (8.2) | 0.57a |
Highest educational qualification (years): mean (SD) | 7.7 (4.7) | 7.4 (4.7) | 0.66a |
Known duration of diabetes | 0.80b | ||
<5 (%) | 30 | 33.6 | |
5–10 (%) | 44.3 | 41.4 | |
>10 (%) | 25.7 | 25 | |
Employment | 0.45b | ||
Unemployed (%) | 5.7 | 7.1 | |
Job at present (%) | 41.4 | 33.6 | |
Retired (%) | 20.7 | 19.3 | |
Housewife (%) | 32.2 | 40 | |
Marital status | 0.21b | ||
Single (%) | 2.9 | 7.1 | |
Married (%) | 80 | 79.3 | |
Divorced (%) | 2.1 | 3.6 | |
Widowed (%) | 15 | 10 | |
Gender | 0.54b | ||
Female (%) | 56.4 | 60.7 | |
Male (%) | 43.6 | 39.3 | |
Insurance coverage | 0.44b | ||
Yes (%) | 95.7 | 92.9 | |
No (%) | 4.3 | 7.1 | |
Main mode of treatment | 0.26b | ||
Insulin (%) | 27.9 | 21.4 | |
Oral hypoglycemic agents (%) | 72.1 | 78.6 | |
Knowledge: mean (SD) | |||
Patients on oral antidiabetic agents (SD) | 0.24 (0.09) | 0.24 (0.09) | 0.83a |
Insulin users (SD) | 0.39 (0.12) | 0.37 (0.12) | 0.49a |
Self-care behavior: mean (SD) | |||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.51a |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | 0.56a |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.38a |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.42a |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.83a |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | 0.16a |
Health beliefs | 2.73 (0.68) | 2.62 (0.66) | 0.19a |
Perceived self-efficacy: mean (SD) | 2.16 (0.70) | 2.17 (0.74) | 0.90a |
Attitudes toward diabetes | |||
Positive attitudes (SD) | 2.77 (0.66) | 2.69 (0.97) | 0.47a |
Negative attitudes (SD) | 3.75 (0.70) | 3.57 (1.08) | 0.09a |
Patient satisfaction: mean (SD) | 3.12 (0.91) | 3.13 (0.91) | 0.93a |
Depression: mean (SD) | 2.56 (0.42) | 2.55 (0.45) | 0.79a |
Stigma (SD) | 3.73 (0.74) | 3.64 (1.06) | 0.38a |
HbA1c: mean (SD) | 9.2 (2.4) | 8.7 (2.3) | 0.07a |
Variable . | Intervention group (n = 140) . | Control group (n = 140) . | p Value . |
---|---|---|---|
Age (years): mean (SD) | 58.0 (8.1) | 57.4 (8.2) | 0.57a |
Highest educational qualification (years): mean (SD) | 7.7 (4.7) | 7.4 (4.7) | 0.66a |
Known duration of diabetes | 0.80b | ||
<5 (%) | 30 | 33.6 | |
5–10 (%) | 44.3 | 41.4 | |
>10 (%) | 25.7 | 25 | |
Employment | 0.45b | ||
Unemployed (%) | 5.7 | 7.1 | |
Job at present (%) | 41.4 | 33.6 | |
Retired (%) | 20.7 | 19.3 | |
Housewife (%) | 32.2 | 40 | |
Marital status | 0.21b | ||
Single (%) | 2.9 | 7.1 | |
Married (%) | 80 | 79.3 | |
Divorced (%) | 2.1 | 3.6 | |
Widowed (%) | 15 | 10 | |
Gender | 0.54b | ||
Female (%) | 56.4 | 60.7 | |
Male (%) | 43.6 | 39.3 | |
Insurance coverage | 0.44b | ||
Yes (%) | 95.7 | 92.9 | |
No (%) | 4.3 | 7.1 | |
Main mode of treatment | 0.26b | ||
Insulin (%) | 27.9 | 21.4 | |
Oral hypoglycemic agents (%) | 72.1 | 78.6 | |
Knowledge: mean (SD) | |||
Patients on oral antidiabetic agents (SD) | 0.24 (0.09) | 0.24 (0.09) | 0.83a |
Insulin users (SD) | 0.39 (0.12) | 0.37 (0.12) | 0.49a |
Self-care behavior: mean (SD) | |||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.51a |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | 0.56a |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.38a |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.42a |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.83a |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | 0.16a |
Health beliefs | 2.73 (0.68) | 2.62 (0.66) | 0.19a |
Perceived self-efficacy: mean (SD) | 2.16 (0.70) | 2.17 (0.74) | 0.90a |
Attitudes toward diabetes | |||
Positive attitudes (SD) | 2.77 (0.66) | 2.69 (0.97) | 0.47a |
Negative attitudes (SD) | 3.75 (0.70) | 3.57 (1.08) | 0.09a |
Patient satisfaction: mean (SD) | 3.12 (0.91) | 3.13 (0.91) | 0.93a |
Depression: mean (SD) | 2.56 (0.42) | 2.55 (0.45) | 0.79a |
Stigma (SD) | 3.73 (0.74) | 3.64 (1.06) | 0.38a |
HbA1c: mean (SD) | 9.2 (2.4) | 8.7 (2.3) | 0.07a |
aStudent's t-tests.
bχ2-test.
Variable . | Intervention group (n = 140) . | Control group (n = 140) . | p Value . |
---|---|---|---|
Age (years): mean (SD) | 58.0 (8.1) | 57.4 (8.2) | 0.57a |
Highest educational qualification (years): mean (SD) | 7.7 (4.7) | 7.4 (4.7) | 0.66a |
Known duration of diabetes | 0.80b | ||
<5 (%) | 30 | 33.6 | |
5–10 (%) | 44.3 | 41.4 | |
>10 (%) | 25.7 | 25 | |
Employment | 0.45b | ||
Unemployed (%) | 5.7 | 7.1 | |
Job at present (%) | 41.4 | 33.6 | |
Retired (%) | 20.7 | 19.3 | |
Housewife (%) | 32.2 | 40 | |
Marital status | 0.21b | ||
Single (%) | 2.9 | 7.1 | |
Married (%) | 80 | 79.3 | |
Divorced (%) | 2.1 | 3.6 | |
Widowed (%) | 15 | 10 | |
Gender | 0.54b | ||
Female (%) | 56.4 | 60.7 | |
Male (%) | 43.6 | 39.3 | |
Insurance coverage | 0.44b | ||
Yes (%) | 95.7 | 92.9 | |
No (%) | 4.3 | 7.1 | |
Main mode of treatment | 0.26b | ||
Insulin (%) | 27.9 | 21.4 | |
Oral hypoglycemic agents (%) | 72.1 | 78.6 | |
Knowledge: mean (SD) | |||
Patients on oral antidiabetic agents (SD) | 0.24 (0.09) | 0.24 (0.09) | 0.83a |
Insulin users (SD) | 0.39 (0.12) | 0.37 (0.12) | 0.49a |
Self-care behavior: mean (SD) | |||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.51a |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | 0.56a |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.38a |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.42a |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.83a |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | 0.16a |
Health beliefs | 2.73 (0.68) | 2.62 (0.66) | 0.19a |
Perceived self-efficacy: mean (SD) | 2.16 (0.70) | 2.17 (0.74) | 0.90a |
Attitudes toward diabetes | |||
Positive attitudes (SD) | 2.77 (0.66) | 2.69 (0.97) | 0.47a |
Negative attitudes (SD) | 3.75 (0.70) | 3.57 (1.08) | 0.09a |
Patient satisfaction: mean (SD) | 3.12 (0.91) | 3.13 (0.91) | 0.93a |
Depression: mean (SD) | 2.56 (0.42) | 2.55 (0.45) | 0.79a |
Stigma (SD) | 3.73 (0.74) | 3.64 (1.06) | 0.38a |
HbA1c: mean (SD) | 9.2 (2.4) | 8.7 (2.3) | 0.07a |
Variable . | Intervention group (n = 140) . | Control group (n = 140) . | p Value . |
---|---|---|---|
Age (years): mean (SD) | 58.0 (8.1) | 57.4 (8.2) | 0.57a |
Highest educational qualification (years): mean (SD) | 7.7 (4.7) | 7.4 (4.7) | 0.66a |
Known duration of diabetes | 0.80b | ||
<5 (%) | 30 | 33.6 | |
5–10 (%) | 44.3 | 41.4 | |
>10 (%) | 25.7 | 25 | |
Employment | 0.45b | ||
Unemployed (%) | 5.7 | 7.1 | |
Job at present (%) | 41.4 | 33.6 | |
Retired (%) | 20.7 | 19.3 | |
Housewife (%) | 32.2 | 40 | |
Marital status | 0.21b | ||
Single (%) | 2.9 | 7.1 | |
Married (%) | 80 | 79.3 | |
Divorced (%) | 2.1 | 3.6 | |
Widowed (%) | 15 | 10 | |
Gender | 0.54b | ||
Female (%) | 56.4 | 60.7 | |
Male (%) | 43.6 | 39.3 | |
Insurance coverage | 0.44b | ||
Yes (%) | 95.7 | 92.9 | |
No (%) | 4.3 | 7.1 | |
Main mode of treatment | 0.26b | ||
Insulin (%) | 27.9 | 21.4 | |
Oral hypoglycemic agents (%) | 72.1 | 78.6 | |
Knowledge: mean (SD) | |||
Patients on oral antidiabetic agents (SD) | 0.24 (0.09) | 0.24 (0.09) | 0.83a |
Insulin users (SD) | 0.39 (0.12) | 0.37 (0.12) | 0.49a |
Self-care behavior: mean (SD) | |||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.51a |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | 0.56a |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.38a |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.42a |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.83a |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | 0.16a |
Health beliefs | 2.73 (0.68) | 2.62 (0.66) | 0.19a |
Perceived self-efficacy: mean (SD) | 2.16 (0.70) | 2.17 (0.74) | 0.90a |
Attitudes toward diabetes | |||
Positive attitudes (SD) | 2.77 (0.66) | 2.69 (0.97) | 0.47a |
Negative attitudes (SD) | 3.75 (0.70) | 3.57 (1.08) | 0.09a |
Patient satisfaction: mean (SD) | 3.12 (0.91) | 3.13 (0.91) | 0.93a |
Depression: mean (SD) | 2.56 (0.42) | 2.55 (0.45) | 0.79a |
Stigma (SD) | 3.73 (0.74) | 3.64 (1.06) | 0.38a |
HbA1c: mean (SD) | 9.2 (2.4) | 8.7 (2.3) | 0.07a |
aStudent's t-tests.
bχ2-test.
Figure 1 shows CONSORT flow chart of participants in the study. Dropout rates were very small for the first and second follow-ups (about 4% or less). At final follow-up assessment (18–21 months after initial assessment), we had a dropout rate of 35% in the intervention group and 39% in the control group. This large dropout rate was due to the movement of the clinic to another building during our follow-up study. We compared baseline demographic and outcome variables between those who completed the study with those who dropped out, for both intervention and control groups. Except for two comparisons, we found no statistically significant differences between those who completed the study, and those who were lost to follow-up in the intervention and control groups (Table 2). Those who were lost to follow-up in the control group were 2.8 years younger than those who completed the study (55.7 versus 58.5; p-value = 0.04). In addition, those who completed the study in the intervention group were more likely to be employed than those who were lost to follow-up (41.7 versus 21.9%; p-value = 0.03).
Variable . | Intervention group . | p Value . | Control group . | p Value . | ||
---|---|---|---|---|---|---|
Completers (n = 91) . | Non-completers (n = 49) . | Completers (n = 85) . | Non-completers (n = 55) . | |||
Age (years): mean (SD) | 58.73 (8.1) | 56.63 (8) | 0.15a | 58.57 (8.5) | 55.70 (7.4) | 0.04a |
Highest educational qualification (years): mean (SD) | 7.32 (4.5) | 8.42 (5.1) | 0.20a | 7.45 (4.8) | 7.47 (5) | 0.98a |
Known duration of diabetes | 0.44b | 0.69b | ||||
<5 (%) | 30.8 | 28.6 | 34.1 | 32.7 | ||
5–10 (%) | 40.6 | 51.0 | 38.8 | 45.5 | ||
>10 (%) | 28.6 | 20.4 | 27.1 | 21.8 | ||
Employment | 0.03b | 0.69b | ||||
Unemployed (%) | 2.2 | 12.2 | 8.2 | 5.4 | ||
Job at present (%) | 41.7 | 40.8 | 34.1 | 32.7 | ||
Retired (%) | 18.7 | 24.5 | 21.2 | 16.4 | ||
Housewife (%) | 37.4 | 22.5 | 36.5 | 45.5 | ||
Marital status | 0.64b | 0.60b | ||||
Single (%) | 2.2 | 4.1 | 9.4 | 3.6 | ||
Married (%) | 78.0 | 83.7 | 76.5 | 83.7 | ||
Divorced (%) | 2.2 | 2.0 | 3.5 | 3.6 | ||
Widowed (%) | 17.6 | 10.2 | 10.6 | 9.1 | ||
Gender | 0.55b | 0.83b | ||||
Female (%) | 58.2 | 53.1 | 60 | 61.8 | ||
Male (%) | 41.8 | 46.9 | 40 | 38.2 | ||
Insurance coverage | 0.06b | 0.16b | ||||
Yes (%) | 93.4 | 100 | 95.3 | 89.1 | ||
No (%) | 6.6 | 0 | 4.7 | 10.9 | ||
Main mode of treatment | 0.89b | 0.11b | ||||
Insulin (%) | 27.5 | 28.6 | 25.9 | 14.5 | ||
Oral hypoglycemic agents (%) | 72.5 | 71.4 | 74.1 | 85.5 | ||
Knowledge: mean (SD) | 0.27 (0.11) | 0.29 (0.14) | 0.36a | 0.27 (0.11) | 0.26 (0.12) | 0.83a |
Self-care behavior: mean (SD) | 2.75 (0.86) | 2.67 (0.87) | 0.61a | 2.87 (0.95) | 2.75 (0.82) | 0.42a |
Health Beliefs: mean (SD) | 2.73 (0.67) | 2.73 (0.70) | 0.99a | 2.63 (0.70) | 2.60 (0.60) | 0.76a |
Perceived self-efficacy: mean (SD) | 2.19 (0.68) | 2.11 (0.76) | 0.51a | 2.16 (0.71) | 2.20 (0.78) | 0.72a |
Attitudes toward diabetes: mean (SD) | ||||||
Positive attitudes | 2.77(0.61) | 2.72 (0.76) | 0.69a | 2.67 (0.96) | 2.73 (1.00) | 0.74a |
Negative attitudes | 3.78 (0.67) | 3.71 (0.76) | 0.58a | 3.53 (1.05) | 3.63 (1.12) | 0.59a |
Patient satisfaction: mean (SD) | 3.10 (0.92) | 3.17 (0.89) | 0.64a | 3.14 (0.92) | 3.12 (0.91) | 0.87a |
Depression: mean (SD) | 2.57 (0.43) | 2.55 (0.41) | 0.77a | 2.56 (0.44) | 2.54 (0.47) | 0.74a |
Stigma: mean (SD) | 3.74 (0.76) | 3.71 (0.72) | 0.81a | 3.60 (1.07) | 3.71 (1.05) | 0.55a |
HbA1c: mean (SD) | 9.23 (2.5) | 9.15 (2.4) | 0.86a | 8.88 (2.2) | 8.63 (2.5) | 0.54a |
Variable . | Intervention group . | p Value . | Control group . | p Value . | ||
---|---|---|---|---|---|---|
Completers (n = 91) . | Non-completers (n = 49) . | Completers (n = 85) . | Non-completers (n = 55) . | |||
Age (years): mean (SD) | 58.73 (8.1) | 56.63 (8) | 0.15a | 58.57 (8.5) | 55.70 (7.4) | 0.04a |
Highest educational qualification (years): mean (SD) | 7.32 (4.5) | 8.42 (5.1) | 0.20a | 7.45 (4.8) | 7.47 (5) | 0.98a |
Known duration of diabetes | 0.44b | 0.69b | ||||
<5 (%) | 30.8 | 28.6 | 34.1 | 32.7 | ||
5–10 (%) | 40.6 | 51.0 | 38.8 | 45.5 | ||
>10 (%) | 28.6 | 20.4 | 27.1 | 21.8 | ||
Employment | 0.03b | 0.69b | ||||
Unemployed (%) | 2.2 | 12.2 | 8.2 | 5.4 | ||
Job at present (%) | 41.7 | 40.8 | 34.1 | 32.7 | ||
Retired (%) | 18.7 | 24.5 | 21.2 | 16.4 | ||
Housewife (%) | 37.4 | 22.5 | 36.5 | 45.5 | ||
Marital status | 0.64b | 0.60b | ||||
Single (%) | 2.2 | 4.1 | 9.4 | 3.6 | ||
Married (%) | 78.0 | 83.7 | 76.5 | 83.7 | ||
Divorced (%) | 2.2 | 2.0 | 3.5 | 3.6 | ||
Widowed (%) | 17.6 | 10.2 | 10.6 | 9.1 | ||
Gender | 0.55b | 0.83b | ||||
Female (%) | 58.2 | 53.1 | 60 | 61.8 | ||
Male (%) | 41.8 | 46.9 | 40 | 38.2 | ||
Insurance coverage | 0.06b | 0.16b | ||||
Yes (%) | 93.4 | 100 | 95.3 | 89.1 | ||
No (%) | 6.6 | 0 | 4.7 | 10.9 | ||
Main mode of treatment | 0.89b | 0.11b | ||||
Insulin (%) | 27.5 | 28.6 | 25.9 | 14.5 | ||
Oral hypoglycemic agents (%) | 72.5 | 71.4 | 74.1 | 85.5 | ||
Knowledge: mean (SD) | 0.27 (0.11) | 0.29 (0.14) | 0.36a | 0.27 (0.11) | 0.26 (0.12) | 0.83a |
Self-care behavior: mean (SD) | 2.75 (0.86) | 2.67 (0.87) | 0.61a | 2.87 (0.95) | 2.75 (0.82) | 0.42a |
Health Beliefs: mean (SD) | 2.73 (0.67) | 2.73 (0.70) | 0.99a | 2.63 (0.70) | 2.60 (0.60) | 0.76a |
Perceived self-efficacy: mean (SD) | 2.19 (0.68) | 2.11 (0.76) | 0.51a | 2.16 (0.71) | 2.20 (0.78) | 0.72a |
Attitudes toward diabetes: mean (SD) | ||||||
Positive attitudes | 2.77(0.61) | 2.72 (0.76) | 0.69a | 2.67 (0.96) | 2.73 (1.00) | 0.74a |
Negative attitudes | 3.78 (0.67) | 3.71 (0.76) | 0.58a | 3.53 (1.05) | 3.63 (1.12) | 0.59a |
Patient satisfaction: mean (SD) | 3.10 (0.92) | 3.17 (0.89) | 0.64a | 3.14 (0.92) | 3.12 (0.91) | 0.87a |
Depression: mean (SD) | 2.57 (0.43) | 2.55 (0.41) | 0.77a | 2.56 (0.44) | 2.54 (0.47) | 0.74a |
Stigma: mean (SD) | 3.74 (0.76) | 3.71 (0.72) | 0.81a | 3.60 (1.07) | 3.71 (1.05) | 0.55a |
HbA1c: mean (SD) | 9.23 (2.5) | 9.15 (2.4) | 0.86a | 8.88 (2.2) | 8.63 (2.5) | 0.54a |
aStudent's t-tests.
bχ2-test.
Variable . | Intervention group . | p Value . | Control group . | p Value . | ||
---|---|---|---|---|---|---|
Completers (n = 91) . | Non-completers (n = 49) . | Completers (n = 85) . | Non-completers (n = 55) . | |||
Age (years): mean (SD) | 58.73 (8.1) | 56.63 (8) | 0.15a | 58.57 (8.5) | 55.70 (7.4) | 0.04a |
Highest educational qualification (years): mean (SD) | 7.32 (4.5) | 8.42 (5.1) | 0.20a | 7.45 (4.8) | 7.47 (5) | 0.98a |
Known duration of diabetes | 0.44b | 0.69b | ||||
<5 (%) | 30.8 | 28.6 | 34.1 | 32.7 | ||
5–10 (%) | 40.6 | 51.0 | 38.8 | 45.5 | ||
>10 (%) | 28.6 | 20.4 | 27.1 | 21.8 | ||
Employment | 0.03b | 0.69b | ||||
Unemployed (%) | 2.2 | 12.2 | 8.2 | 5.4 | ||
Job at present (%) | 41.7 | 40.8 | 34.1 | 32.7 | ||
Retired (%) | 18.7 | 24.5 | 21.2 | 16.4 | ||
Housewife (%) | 37.4 | 22.5 | 36.5 | 45.5 | ||
Marital status | 0.64b | 0.60b | ||||
Single (%) | 2.2 | 4.1 | 9.4 | 3.6 | ||
Married (%) | 78.0 | 83.7 | 76.5 | 83.7 | ||
Divorced (%) | 2.2 | 2.0 | 3.5 | 3.6 | ||
Widowed (%) | 17.6 | 10.2 | 10.6 | 9.1 | ||
Gender | 0.55b | 0.83b | ||||
Female (%) | 58.2 | 53.1 | 60 | 61.8 | ||
Male (%) | 41.8 | 46.9 | 40 | 38.2 | ||
Insurance coverage | 0.06b | 0.16b | ||||
Yes (%) | 93.4 | 100 | 95.3 | 89.1 | ||
No (%) | 6.6 | 0 | 4.7 | 10.9 | ||
Main mode of treatment | 0.89b | 0.11b | ||||
Insulin (%) | 27.5 | 28.6 | 25.9 | 14.5 | ||
Oral hypoglycemic agents (%) | 72.5 | 71.4 | 74.1 | 85.5 | ||
Knowledge: mean (SD) | 0.27 (0.11) | 0.29 (0.14) | 0.36a | 0.27 (0.11) | 0.26 (0.12) | 0.83a |
Self-care behavior: mean (SD) | 2.75 (0.86) | 2.67 (0.87) | 0.61a | 2.87 (0.95) | 2.75 (0.82) | 0.42a |
Health Beliefs: mean (SD) | 2.73 (0.67) | 2.73 (0.70) | 0.99a | 2.63 (0.70) | 2.60 (0.60) | 0.76a |
Perceived self-efficacy: mean (SD) | 2.19 (0.68) | 2.11 (0.76) | 0.51a | 2.16 (0.71) | 2.20 (0.78) | 0.72a |
Attitudes toward diabetes: mean (SD) | ||||||
Positive attitudes | 2.77(0.61) | 2.72 (0.76) | 0.69a | 2.67 (0.96) | 2.73 (1.00) | 0.74a |
Negative attitudes | 3.78 (0.67) | 3.71 (0.76) | 0.58a | 3.53 (1.05) | 3.63 (1.12) | 0.59a |
Patient satisfaction: mean (SD) | 3.10 (0.92) | 3.17 (0.89) | 0.64a | 3.14 (0.92) | 3.12 (0.91) | 0.87a |
Depression: mean (SD) | 2.57 (0.43) | 2.55 (0.41) | 0.77a | 2.56 (0.44) | 2.54 (0.47) | 0.74a |
Stigma: mean (SD) | 3.74 (0.76) | 3.71 (0.72) | 0.81a | 3.60 (1.07) | 3.71 (1.05) | 0.55a |
HbA1c: mean (SD) | 9.23 (2.5) | 9.15 (2.4) | 0.86a | 8.88 (2.2) | 8.63 (2.5) | 0.54a |
Variable . | Intervention group . | p Value . | Control group . | p Value . | ||
---|---|---|---|---|---|---|
Completers (n = 91) . | Non-completers (n = 49) . | Completers (n = 85) . | Non-completers (n = 55) . | |||
Age (years): mean (SD) | 58.73 (8.1) | 56.63 (8) | 0.15a | 58.57 (8.5) | 55.70 (7.4) | 0.04a |
Highest educational qualification (years): mean (SD) | 7.32 (4.5) | 8.42 (5.1) | 0.20a | 7.45 (4.8) | 7.47 (5) | 0.98a |
Known duration of diabetes | 0.44b | 0.69b | ||||
<5 (%) | 30.8 | 28.6 | 34.1 | 32.7 | ||
5–10 (%) | 40.6 | 51.0 | 38.8 | 45.5 | ||
>10 (%) | 28.6 | 20.4 | 27.1 | 21.8 | ||
Employment | 0.03b | 0.69b | ||||
Unemployed (%) | 2.2 | 12.2 | 8.2 | 5.4 | ||
Job at present (%) | 41.7 | 40.8 | 34.1 | 32.7 | ||
Retired (%) | 18.7 | 24.5 | 21.2 | 16.4 | ||
Housewife (%) | 37.4 | 22.5 | 36.5 | 45.5 | ||
Marital status | 0.64b | 0.60b | ||||
Single (%) | 2.2 | 4.1 | 9.4 | 3.6 | ||
Married (%) | 78.0 | 83.7 | 76.5 | 83.7 | ||
Divorced (%) | 2.2 | 2.0 | 3.5 | 3.6 | ||
Widowed (%) | 17.6 | 10.2 | 10.6 | 9.1 | ||
Gender | 0.55b | 0.83b | ||||
Female (%) | 58.2 | 53.1 | 60 | 61.8 | ||
Male (%) | 41.8 | 46.9 | 40 | 38.2 | ||
Insurance coverage | 0.06b | 0.16b | ||||
Yes (%) | 93.4 | 100 | 95.3 | 89.1 | ||
No (%) | 6.6 | 0 | 4.7 | 10.9 | ||
Main mode of treatment | 0.89b | 0.11b | ||||
Insulin (%) | 27.5 | 28.6 | 25.9 | 14.5 | ||
Oral hypoglycemic agents (%) | 72.5 | 71.4 | 74.1 | 85.5 | ||
Knowledge: mean (SD) | 0.27 (0.11) | 0.29 (0.14) | 0.36a | 0.27 (0.11) | 0.26 (0.12) | 0.83a |
Self-care behavior: mean (SD) | 2.75 (0.86) | 2.67 (0.87) | 0.61a | 2.87 (0.95) | 2.75 (0.82) | 0.42a |
Health Beliefs: mean (SD) | 2.73 (0.67) | 2.73 (0.70) | 0.99a | 2.63 (0.70) | 2.60 (0.60) | 0.76a |
Perceived self-efficacy: mean (SD) | 2.19 (0.68) | 2.11 (0.76) | 0.51a | 2.16 (0.71) | 2.20 (0.78) | 0.72a |
Attitudes toward diabetes: mean (SD) | ||||||
Positive attitudes | 2.77(0.61) | 2.72 (0.76) | 0.69a | 2.67 (0.96) | 2.73 (1.00) | 0.74a |
Negative attitudes | 3.78 (0.67) | 3.71 (0.76) | 0.58a | 3.53 (1.05) | 3.63 (1.12) | 0.59a |
Patient satisfaction: mean (SD) | 3.10 (0.92) | 3.17 (0.89) | 0.64a | 3.14 (0.92) | 3.12 (0.91) | 0.87a |
Depression: mean (SD) | 2.57 (0.43) | 2.55 (0.41) | 0.77a | 2.56 (0.44) | 2.54 (0.47) | 0.74a |
Stigma: mean (SD) | 3.74 (0.76) | 3.71 (0.72) | 0.81a | 3.60 (1.07) | 3.71 (1.05) | 0.55a |
HbA1c: mean (SD) | 9.23 (2.5) | 9.15 (2.4) | 0.86a | 8.88 (2.2) | 8.63 (2.5) | 0.54a |
aStudent's t-tests.
bχ2-test.
Lifestyle and psychological outcomes
Table 3 shows differences of outcome measures between the PDSME program and control groups.
Outcomesa . | Baseline data . | Two-weeks data . | Eight-weeks data . | Overall change . | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 138) . | Control group (SD) (n = 138) . | Difference in means (95% CI) . | Intervention group (SD) (n = 134) . | Control group (SD) (n = 135) . | Difference in means (95% CI) . | Repeated measures ANOVA p Value . | |
Diabetes knowledge score | ||||||||||
Patients on oral hypoglycemic agents | 0.24 (0.09) | 0.24 (0.09) | 0.00 (−0.02, 0.02) | 0.44 (0.16) | 0.28 (0.13) | −0.15 (−0.020, −0.11) | 0.39 (0.15) | 0.28 (0.13) | −0.10 (−0.14, −0.06) | <0.001* |
Insulin users | 0.39 (0.12) | 0.37 (0.12) | −0.02 (−0.07, 0.03) | 0.43 (0.10) | 0.28 (0.11) | −0.15 (−0.21, −0.10) | 0.37 (0.11) | 0.28 (0.11) | −0.09 (−0.15, −0.04) | 0.06* |
Self-care activity | ||||||||||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.14 (−0.29, 0.57) | 2.07 (1.80) | 1.74 (1.91) | −0.32 (−0.77, 0.12) | 2.43 (2.04) | 2.03 (1.80) | −0.39 (−0.86, 0.06 | 0.07 |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | −0.29 (−1.30, 0.71) | 5.01 (2.51) | 3.37 (2.15) | −1.63 (−2.63, −0.64) | 4.91 (2.55) | 3.18 (2.00) | −1.72 (−2.70, −0.74) | <0.001* |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.21 (−0.26, 0.68) | 2.35 (2.28) | 1.78 (1.82) | −0.57 (−1.08, −0.72) | 2.76 (2.43) | 1.97 (1.81) | −0.79 (−1.31, −0.27) | <0.001* |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.19 (−0.28, 0.68) | 3.32 (2.10) | 2.57 (2.11) | −0.74 (−1.24, −0.24) | 3.18 (2.37) | 2.37 (1.80) | −0.80 (−1.29, −0.32) | <0.001* |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.04 (−0.35, 0.43) | 4.29 (2.11) | 2.84 (1.66) | −1.44 (−1.90, −0.98) | 4.91 (2.14) | 2.82 (1.67) | −2.09 (−2.56, −1.62) | <0.001* |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | −0.05 (−0.12, 0.02) | 0.92 (0.26) | 0.88 (0.31) | −0.03 (−0.11, 0.03) | 0.93 (0.25) | 0.89 (0.31) | −0.03 (−0.11, 0.03) | 0.1 |
Psychosocial outcomes | ||||||||||
Health Beliefs | 2.73 (0.68) | 2.62 (0.66) | −0.1 (−0.2, 0.05) | 2.9 (0.56) | 2.5 (0.61) | −0.3 (−0.5, −0.2) | 2.99 (0.54) | 2.5 (0.56) | −0.4 (−0.5, −0.3) | 0.01* |
Perceived self-efficacy | 2.16 (0.7) | 2.17 (0.7) | 0.01 (−0.1, 0.1) | 3.11 (0.8) | 2.19 (0.6) | −0.92 (−1.1, −0.7) | 3.07 (0.8) | 2.19 (0.6) | −0.87 (−1.0, −0.6) | <0.001* |
Attitudes toward diabetes | ||||||||||
Positive attitudes | 2.77 (0.66) | 2.69 (0.97) | −0.07 (−0.26, 0.12) | 3.54 (0.68) | 2.68 (0.99) | −0.85 (−1.0, −0.65) | 3.49 (0.66) | 2.73 (0.98) | −0.75 (−0.96, −0.55) | <0.001* |
Negative attitudes | 3.75 (0.70) | 3.57 (1.08) | −0.18 (−0.39, 0.03) | 3.08 (0.91) | 3.36 (1.19) | 0.27 (0.03, 0.52) | 3.04 (0.93) | 3.36 (1.20) | 0.31 (0.06, 0.56) | <0.001* |
Depression | 2.56 (0.4) | 2.55 (0.4) | −0.01 (−0.1, 0.0) | 2.56 (0.4) | 2.54 (0.4) | −0.01 (−0.1, 0.0) | 2.5 (0.4) | 2.53 (0.4) | 0.05 (−0.1, 0.1) | 0.22 |
Stigma | 3.73 (0.74) | 3.64 (1.06) | −0.09 (−0.31, 0.12) | 2.94 (0.88) | 3.31 (1.22) | 0.36 (0.11, 0.61) | 2.95 (0.88) | 3.37 (1.17) | 0.42 (0.17,0.66) | <0.001* |
Patient satisfactionb | 3.12 (0.9) | 3.13 (0.9) | 0.00 (−0.2, 0.2) | 2.50 (0.7) | 3.14 (0.8) | 0.64 (0.4, 0.8) | 2.62 (0.7) | 3.27 (0.8) | 0.64 (0.4, 0.8) | <0.001* |
Outcomesa . | Baseline data . | Two-weeks data . | Eight-weeks data . | Overall change . | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 138) . | Control group (SD) (n = 138) . | Difference in means (95% CI) . | Intervention group (SD) (n = 134) . | Control group (SD) (n = 135) . | Difference in means (95% CI) . | Repeated measures ANOVA p Value . | |
Diabetes knowledge score | ||||||||||
Patients on oral hypoglycemic agents | 0.24 (0.09) | 0.24 (0.09) | 0.00 (−0.02, 0.02) | 0.44 (0.16) | 0.28 (0.13) | −0.15 (−0.020, −0.11) | 0.39 (0.15) | 0.28 (0.13) | −0.10 (−0.14, −0.06) | <0.001* |
Insulin users | 0.39 (0.12) | 0.37 (0.12) | −0.02 (−0.07, 0.03) | 0.43 (0.10) | 0.28 (0.11) | −0.15 (−0.21, −0.10) | 0.37 (0.11) | 0.28 (0.11) | −0.09 (−0.15, −0.04) | 0.06* |
Self-care activity | ||||||||||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.14 (−0.29, 0.57) | 2.07 (1.80) | 1.74 (1.91) | −0.32 (−0.77, 0.12) | 2.43 (2.04) | 2.03 (1.80) | −0.39 (−0.86, 0.06 | 0.07 |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | −0.29 (−1.30, 0.71) | 5.01 (2.51) | 3.37 (2.15) | −1.63 (−2.63, −0.64) | 4.91 (2.55) | 3.18 (2.00) | −1.72 (−2.70, −0.74) | <0.001* |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.21 (−0.26, 0.68) | 2.35 (2.28) | 1.78 (1.82) | −0.57 (−1.08, −0.72) | 2.76 (2.43) | 1.97 (1.81) | −0.79 (−1.31, −0.27) | <0.001* |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.19 (−0.28, 0.68) | 3.32 (2.10) | 2.57 (2.11) | −0.74 (−1.24, −0.24) | 3.18 (2.37) | 2.37 (1.80) | −0.80 (−1.29, −0.32) | <0.001* |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.04 (−0.35, 0.43) | 4.29 (2.11) | 2.84 (1.66) | −1.44 (−1.90, −0.98) | 4.91 (2.14) | 2.82 (1.67) | −2.09 (−2.56, −1.62) | <0.001* |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | −0.05 (−0.12, 0.02) | 0.92 (0.26) | 0.88 (0.31) | −0.03 (−0.11, 0.03) | 0.93 (0.25) | 0.89 (0.31) | −0.03 (−0.11, 0.03) | 0.1 |
Psychosocial outcomes | ||||||||||
Health Beliefs | 2.73 (0.68) | 2.62 (0.66) | −0.1 (−0.2, 0.05) | 2.9 (0.56) | 2.5 (0.61) | −0.3 (−0.5, −0.2) | 2.99 (0.54) | 2.5 (0.56) | −0.4 (−0.5, −0.3) | 0.01* |
Perceived self-efficacy | 2.16 (0.7) | 2.17 (0.7) | 0.01 (−0.1, 0.1) | 3.11 (0.8) | 2.19 (0.6) | −0.92 (−1.1, −0.7) | 3.07 (0.8) | 2.19 (0.6) | −0.87 (−1.0, −0.6) | <0.001* |
Attitudes toward diabetes | ||||||||||
Positive attitudes | 2.77 (0.66) | 2.69 (0.97) | −0.07 (−0.26, 0.12) | 3.54 (0.68) | 2.68 (0.99) | −0.85 (−1.0, −0.65) | 3.49 (0.66) | 2.73 (0.98) | −0.75 (−0.96, −0.55) | <0.001* |
Negative attitudes | 3.75 (0.70) | 3.57 (1.08) | −0.18 (−0.39, 0.03) | 3.08 (0.91) | 3.36 (1.19) | 0.27 (0.03, 0.52) | 3.04 (0.93) | 3.36 (1.20) | 0.31 (0.06, 0.56) | <0.001* |
Depression | 2.56 (0.4) | 2.55 (0.4) | −0.01 (−0.1, 0.0) | 2.56 (0.4) | 2.54 (0.4) | −0.01 (−0.1, 0.0) | 2.5 (0.4) | 2.53 (0.4) | 0.05 (−0.1, 0.1) | 0.22 |
Stigma | 3.73 (0.74) | 3.64 (1.06) | −0.09 (−0.31, 0.12) | 2.94 (0.88) | 3.31 (1.22) | 0.36 (0.11, 0.61) | 2.95 (0.88) | 3.37 (1.17) | 0.42 (0.17,0.66) | <0.001* |
Patient satisfactionb | 3.12 (0.9) | 3.13 (0.9) | 0.00 (−0.2, 0.2) | 2.50 (0.7) | 3.14 (0.8) | 0.64 (0.4, 0.8) | 2.62 (0.7) | 3.27 (0.8) | 0.64 (0.4, 0.8) | <0.001* |
aReported values are means (SD).
bLower scores reflected higher patient satisfaction with diabetes care.
*Significant at p-value <0.05.
Outcomesa . | Baseline data . | Two-weeks data . | Eight-weeks data . | Overall change . | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 138) . | Control group (SD) (n = 138) . | Difference in means (95% CI) . | Intervention group (SD) (n = 134) . | Control group (SD) (n = 135) . | Difference in means (95% CI) . | Repeated measures ANOVA p Value . | |
Diabetes knowledge score | ||||||||||
Patients on oral hypoglycemic agents | 0.24 (0.09) | 0.24 (0.09) | 0.00 (−0.02, 0.02) | 0.44 (0.16) | 0.28 (0.13) | −0.15 (−0.020, −0.11) | 0.39 (0.15) | 0.28 (0.13) | −0.10 (−0.14, −0.06) | <0.001* |
Insulin users | 0.39 (0.12) | 0.37 (0.12) | −0.02 (−0.07, 0.03) | 0.43 (0.10) | 0.28 (0.11) | −0.15 (−0.21, −0.10) | 0.37 (0.11) | 0.28 (0.11) | −0.09 (−0.15, −0.04) | 0.06* |
Self-care activity | ||||||||||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.14 (−0.29, 0.57) | 2.07 (1.80) | 1.74 (1.91) | −0.32 (−0.77, 0.12) | 2.43 (2.04) | 2.03 (1.80) | −0.39 (−0.86, 0.06 | 0.07 |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | −0.29 (−1.30, 0.71) | 5.01 (2.51) | 3.37 (2.15) | −1.63 (−2.63, −0.64) | 4.91 (2.55) | 3.18 (2.00) | −1.72 (−2.70, −0.74) | <0.001* |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.21 (−0.26, 0.68) | 2.35 (2.28) | 1.78 (1.82) | −0.57 (−1.08, −0.72) | 2.76 (2.43) | 1.97 (1.81) | −0.79 (−1.31, −0.27) | <0.001* |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.19 (−0.28, 0.68) | 3.32 (2.10) | 2.57 (2.11) | −0.74 (−1.24, −0.24) | 3.18 (2.37) | 2.37 (1.80) | −0.80 (−1.29, −0.32) | <0.001* |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.04 (−0.35, 0.43) | 4.29 (2.11) | 2.84 (1.66) | −1.44 (−1.90, −0.98) | 4.91 (2.14) | 2.82 (1.67) | −2.09 (−2.56, −1.62) | <0.001* |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | −0.05 (−0.12, 0.02) | 0.92 (0.26) | 0.88 (0.31) | −0.03 (−0.11, 0.03) | 0.93 (0.25) | 0.89 (0.31) | −0.03 (−0.11, 0.03) | 0.1 |
Psychosocial outcomes | ||||||||||
Health Beliefs | 2.73 (0.68) | 2.62 (0.66) | −0.1 (−0.2, 0.05) | 2.9 (0.56) | 2.5 (0.61) | −0.3 (−0.5, −0.2) | 2.99 (0.54) | 2.5 (0.56) | −0.4 (−0.5, −0.3) | 0.01* |
Perceived self-efficacy | 2.16 (0.7) | 2.17 (0.7) | 0.01 (−0.1, 0.1) | 3.11 (0.8) | 2.19 (0.6) | −0.92 (−1.1, −0.7) | 3.07 (0.8) | 2.19 (0.6) | −0.87 (−1.0, −0.6) | <0.001* |
Attitudes toward diabetes | ||||||||||
Positive attitudes | 2.77 (0.66) | 2.69 (0.97) | −0.07 (−0.26, 0.12) | 3.54 (0.68) | 2.68 (0.99) | −0.85 (−1.0, −0.65) | 3.49 (0.66) | 2.73 (0.98) | −0.75 (−0.96, −0.55) | <0.001* |
Negative attitudes | 3.75 (0.70) | 3.57 (1.08) | −0.18 (−0.39, 0.03) | 3.08 (0.91) | 3.36 (1.19) | 0.27 (0.03, 0.52) | 3.04 (0.93) | 3.36 (1.20) | 0.31 (0.06, 0.56) | <0.001* |
Depression | 2.56 (0.4) | 2.55 (0.4) | −0.01 (−0.1, 0.0) | 2.56 (0.4) | 2.54 (0.4) | −0.01 (−0.1, 0.0) | 2.5 (0.4) | 2.53 (0.4) | 0.05 (−0.1, 0.1) | 0.22 |
Stigma | 3.73 (0.74) | 3.64 (1.06) | −0.09 (−0.31, 0.12) | 2.94 (0.88) | 3.31 (1.22) | 0.36 (0.11, 0.61) | 2.95 (0.88) | 3.37 (1.17) | 0.42 (0.17,0.66) | <0.001* |
Patient satisfactionb | 3.12 (0.9) | 3.13 (0.9) | 0.00 (−0.2, 0.2) | 2.50 (0.7) | 3.14 (0.8) | 0.64 (0.4, 0.8) | 2.62 (0.7) | 3.27 (0.8) | 0.64 (0.4, 0.8) | <0.001* |
Outcomesa . | Baseline data . | Two-weeks data . | Eight-weeks data . | Overall change . | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 138) . | Control group (SD) (n = 138) . | Difference in means (95% CI) . | Intervention group (SD) (n = 134) . | Control group (SD) (n = 135) . | Difference in means (95% CI) . | Repeated measures ANOVA p Value . | |
Diabetes knowledge score | ||||||||||
Patients on oral hypoglycemic agents | 0.24 (0.09) | 0.24 (0.09) | 0.00 (−0.02, 0.02) | 0.44 (0.16) | 0.28 (0.13) | −0.15 (−0.020, −0.11) | 0.39 (0.15) | 0.28 (0.13) | −0.10 (−0.14, −0.06) | <0.001* |
Insulin users | 0.39 (0.12) | 0.37 (0.12) | −0.02 (−0.07, 0.03) | 0.43 (0.10) | 0.28 (0.11) | −0.15 (−0.21, −0.10) | 0.37 (0.11) | 0.28 (0.11) | −0.09 (−0.15, −0.04) | 0.06* |
Self-care activity | ||||||||||
General diet | 1.55 (1.78) | 1.69 (1.84) | 0.14 (−0.29, 0.57) | 2.07 (1.80) | 1.74 (1.91) | −0.32 (−0.77, 0.12) | 2.43 (2.04) | 2.03 (1.80) | −0.39 (−0.86, 0.06 | 0.07 |
Specific diet | 4.06 (2.26) | 3.77 (2.42) | −0.29 (−1.30, 0.71) | 5.01 (2.51) | 3.37 (2.15) | −1.63 (−2.63, −0.64) | 4.91 (2.55) | 3.18 (2.00) | −1.72 (−2.70, −0.74) | <0.001* |
Exercise | 1.59 (1.89) | 1.80 (2.02) | 0.21 (−0.26, 0.68) | 2.35 (2.28) | 1.78 (1.82) | −0.57 (−1.08, −0.72) | 2.76 (2.43) | 1.97 (1.81) | −0.79 (−1.31, −0.27) | <0.001* |
Blood glucose testing | 2.11 (1.99) | 2.31 (2.08) | 0.19 (−0.28, 0.68) | 3.32 (2.10) | 2.57 (2.11) | −0.74 (−1.24, −0.24) | 3.18 (2.37) | 2.37 (1.80) | −0.80 (−1.29, −0.32) | <0.001* |
Foot-care | 2.80 (1.58) | 2.84 (1.66) | 0.04 (−0.35, 0.43) | 4.29 (2.11) | 2.84 (1.66) | −1.44 (−1.90, −0.98) | 4.91 (2.14) | 2.82 (1.67) | −2.09 (−2.56, −1.62) | <0.001* |
Smoking status | 0.91 (0.27) | 0.86 (0.34) | −0.05 (−0.12, 0.02) | 0.92 (0.26) | 0.88 (0.31) | −0.03 (−0.11, 0.03) | 0.93 (0.25) | 0.89 (0.31) | −0.03 (−0.11, 0.03) | 0.1 |
Psychosocial outcomes | ||||||||||
Health Beliefs | 2.73 (0.68) | 2.62 (0.66) | −0.1 (−0.2, 0.05) | 2.9 (0.56) | 2.5 (0.61) | −0.3 (−0.5, −0.2) | 2.99 (0.54) | 2.5 (0.56) | −0.4 (−0.5, −0.3) | 0.01* |
Perceived self-efficacy | 2.16 (0.7) | 2.17 (0.7) | 0.01 (−0.1, 0.1) | 3.11 (0.8) | 2.19 (0.6) | −0.92 (−1.1, −0.7) | 3.07 (0.8) | 2.19 (0.6) | −0.87 (−1.0, −0.6) | <0.001* |
Attitudes toward diabetes | ||||||||||
Positive attitudes | 2.77 (0.66) | 2.69 (0.97) | −0.07 (−0.26, 0.12) | 3.54 (0.68) | 2.68 (0.99) | −0.85 (−1.0, −0.65) | 3.49 (0.66) | 2.73 (0.98) | −0.75 (−0.96, −0.55) | <0.001* |
Negative attitudes | 3.75 (0.70) | 3.57 (1.08) | −0.18 (−0.39, 0.03) | 3.08 (0.91) | 3.36 (1.19) | 0.27 (0.03, 0.52) | 3.04 (0.93) | 3.36 (1.20) | 0.31 (0.06, 0.56) | <0.001* |
Depression | 2.56 (0.4) | 2.55 (0.4) | −0.01 (−0.1, 0.0) | 2.56 (0.4) | 2.54 (0.4) | −0.01 (−0.1, 0.0) | 2.5 (0.4) | 2.53 (0.4) | 0.05 (−0.1, 0.1) | 0.22 |
Stigma | 3.73 (0.74) | 3.64 (1.06) | −0.09 (−0.31, 0.12) | 2.94 (0.88) | 3.31 (1.22) | 0.36 (0.11, 0.61) | 2.95 (0.88) | 3.37 (1.17) | 0.42 (0.17,0.66) | <0.001* |
Patient satisfactionb | 3.12 (0.9) | 3.13 (0.9) | 0.00 (−0.2, 0.2) | 2.50 (0.7) | 3.14 (0.8) | 0.64 (0.4, 0.8) | 2.62 (0.7) | 3.27 (0.8) | 0.64 (0.4, 0.8) | <0.001* |
aReported values are means (SD).
bLower scores reflected higher patient satisfaction with diabetes care.
*Significant at p-value <0.05.
While the mean knowledge scores in the control group did not change during the study, the mean knowledge scores among patients treated with oral antidiabetic agents in the intervention group increased from 0.24 (SD: 0.09) at the baseline to 0.39 (SD: 0.1) at 8-week follow-up (p < 0.001). Among insulin users, the mean knowledge score in the intervention group was 0.39 (SD: 0.1) at baseline; and it remained constant (0.37; SD: 0.11) at 8-week follow-up.
At 4- and 8-week follow-ups, there were significant differences in the number of days each week the PDSME patients were adhering to four out of the six self-care activities measured in the study. The activities included: adhering to specific diet (8-week follow-up: difference 1.72 day; 95% CI −2.70, −0.74), exercising (8-week follow-up: difference 0.79 day; 95% CI −1.31, −0.27), self-monitoring blood glucose levels (8-week follow-up: difference 0.80 day; 95% CI −1.29, −0.32) and performing foot-care self-management (8-week follow-up: difference 2.09 day; 95% CI −2.56, −1.62) compared with those receiving usual care. There were significant differences between the two groups (p < 0.001) in above-mentioned self-care behaviors. There was no significant difference between the PDSME patients and those who received usual care in the number of days each week adhering to general diet. No significant difference was also found for smoking status during both follow-ups.
Regarding psychological outcomes, the health beliefs score improved more in the PDSME patients; from 2.73 (SD: 0.6) at the baseline to 2.99 (SD: 0.5) at 8-week follow-up. There was a significant effect over time (p = 0.01) for the health beliefs. There was a significant difference between the two groups (p < 0.001) in health beliefs score. The intervention group's positive attitudes toward diabetes scores increased from 2.77 (SD; 0.66) at baseline to 3.49 (SD: 0.66) at 8-week follow-up (p < 0.001), and negative attitudes toward diabetes score decreased more in the PDSME patients; from 3.75 (SD: 0.70) at baseline to 3.04 (SD 0.93) at 8-weeks follow-up (p < 0.001). We observed a significant difference between the two groups (p < 0.001). There was a significant effect over time (p < 0.001) for self-efficacy.
The average score of self-efficacy increased significantly from 2.16 (SD: 0.7) at baseline to 3.07 (SD: 0.8) at 8-week follow-up. The test of between-subjects effects indicated significant difference between the two groups (p < 0.001). The PDSME patients were more satisfied with diabetes care compared with patients receiving usual care at 2 and 8 weeks (p < 0.001), and their satisfaction improved at 8 weeks compared with 2 weeks (p < 0.001). The test of between-subjects effects indicated significant difference between the two groups (p < 0.001). There was no significant differences between the two groups in depression (p = 0.7) score.
Clinical outcome
Between the 269 intervention and control groups participants, 174 (64.6%) participated in the 18–21 months HbA1c measurement (Figure 1). At 18–21 months follow-up, the PDSME group members showed significant improvements in the mean HbA1c compared with the control group (−1.1 versus +0.2%, p = 0.008; Table 4).
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.4) | 8.7 (2.3) | −0.49 (−1.0, 0.06) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.008* |
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.4) | 8.7 (2.3) | −0.49 (−1.0, 0.06) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.008* |
*Significant at p-value <0.05.
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.4) | 8.7 (2.3) | −0.49 (−1.0, 0.06) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.008* |
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 140) . | Control group (SD) (n = 140) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.4) | 8.7 (2.3) | −0.49 (−1.0, 0.06) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.008* |
*Significant at p-value <0.05.
As a sensitivity analysis, since there was a large dropout before the 18–21 month follow-up, we conducted a ‘per protocol’ analysis and reported the HbA1c change among those with complete data both at baseline and follow-up measurements. The results showed significant improvements in the mean HbA1c compared with the control group (−1.1 versus +0.1%, p = 0.00; Table 5).
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.5) | 8.8 (2.2) | −0.34 (−1.07, 0.37) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.000* |
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.5) | 8.8 (2.2) | −0.34 (−1.07, 0.37) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.000* |
*Significant at p-value <0.05.
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.5) | 8.8 (2.2) | −0.34 (−1.07, 0.37) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.000* |
Outcome . | Baseline data . | 18–21 months data . | Overall change . | ||||
---|---|---|---|---|---|---|---|
Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | Intervention group (SD) (n = 91) . | Control group (SD) (n = 85) . | Difference in means (95% CI) . | p Value . | |
HbA1c | 9.2 (2.5) | 8.8 (2.2) | −0.34 (−1.07, 0.37) | 8.1 (1.6) | 8.9 (2.2) | 0.78 (0.2, 1.36) | 0.000* |
*Significant at p-value <0.05.
DISCUSSION
Our study adds to the body of evidence demonstrating that structured DSME leads to improvements in diabetes patients’ health behavior and clinical outcomes. Key area of improvement was a reduction in HbA1c (about 1%) at 18–21 months follow-up.
HbA1c dramatically decreased in the intervention group within 18–21 months. Still, the follow-up mean HbA1c level in the intervention group (8.1%) was markedly higher than recommended levels for diabetes control (lower than 6.5%) (American Diabetes Association, 2010). It should be noted that any declines in HbA1c levels affect clinical manifestations of diabetes.
The Diabetes Control and Complications Trial demonstrated that 1% decline in HbA1c reduced micro-vascular complications by 30% or more (American Diabetes Association, 2010). They also demonstrated that reductions in micro-vascular complications, in particular retinopathy, can be observed with sustained HbA1c reductions even if it was not reduced to below 7% (American Diabetes Association, 2010). Therefore, reductions observed as the result of our intervention are clinically important improvements.
Different factors may explain why we could not reach recommended HbA1c level. The mean HbA1c at baseline was very high (9.2%); and duration of our intervention was short. It might be that lowering HbA1c to recommended levels needs longer interventions. In addition, results of a needs assessment qualitative study that explored experience of Iranian patients about factors that affected diabetes self-care identified lack of family support as a main barrier (Shakibazadeh et al., 2011). Hence, at the beginning of our intervention, we asked each participant to identify a family member, preferably a spouse or a first-degree relative, to participate as a support person in the sessions. While most participants offered names, very few relatives actually attended the program. It seems that appropriate strategies should be considered to involve patients’ supporters. Also that we provided only two ‘booster’ sessions, each 2 weeks apart. Perhaps future studies should consider further booster sessions for a longer period of time to improve program's health outcomes.
Although persistent elevations in blood sugar (and, therefore, HbA1c) increase risk of long-term multi-organ vascular complications of diabetes, recent evidence from large trials have suggested that setting an HbA1c below 7% for patients may be excessive. It seems that below 7%, health benefits of reducing HbA1c become relatively smaller, and intensive glycemic control required to reach below 7% may lead to more dangerous hypoglycemic episodes (Lehman and Krumholz, 2009). Patients at a high risk of micro-vascular complications may gain further benefits from reducing HbA1c below 7%.
An external factor might have affected the dropout of some patients. The clinic's building was moved to a new location during the study period, which might have made it difficult for some patients to complete the follow-ups. Still, both intention to treat and per protocol analyses suggested a reduction of ∼1% in the HbA1c in the intervention group within 18–21 months.
There are few educational programs available for patients with diabetes in Iran. In the public sector, diabetes clinics of public hospitals provide education to patients; however, these educational interventions are not necessarily provided in a theory-based approach. Also, in the private sector, there are few non-governmental organizations, such as Gabric [www.gabric.ir (19 February 2015, date last accessed)], and Iranian Diabetes Society [http://ids.org.ir (19 February 2015, date last accessed)], mostly located in Tehran, which provide relatively comprehensive educational classes to patients. Although some of these centers seem to be successful in educating patients, no formal evaluations have been conducted to assess the impact of their educational activities on patients’ outcomes.
As our study was the first structured educational program of its kind in Iran, the paucity of information on implementing theory-driven structured programs did not allow for a comparison with other local programs (Baradaran et al., 2010). There are also limited studies in similar settings that have assessed structured self-management programs or adapted programs from standard programs (Atak et al., 2009; Wallia et al., 2013). On the other hand, there are valuable structured interventions worldwide, which have reported significant improvements in outcomes (Deakin et al., 2006; Skinner et al., 2006; Davies et al., 2008). Davies et al. (Davies et al., 2008) in the UK evaluated effects of a structured group education program in people with diabetes. Participants in the intervention group showed greater improvements in key health outcomes and HbA1c levels. In another study in the UK (Deakin et al., 2006), effectiveness of a self-management program on clinical, lifestyle and psychosocial outcomes was assessed. Results showed improvements in glycemic control, knowledge and self-management skills.
Knowledge of patients who received insulin remained flat in our study. The mean score of knowledge among insulin users was high at baseline. It may be that insulin users look for more information due to the relative criticality of their condition and treatment. Our patients did not change their smoking status. It seems that more comprehensive programs should be designed specifically on smoking cessation among patients with diabetes. However, there were few cigarette smokers in our study at baseline.
Depression is common in those with diabetes as we found with our participants. We referred several participants in the intervention group to psychiatrists; however, depression scores were not improved in the end. This is possibly because of short follow-up of cognitive outcomes. Other studies have shown significant decrease in depression score at later follow-ups in the intervention group (Davies et al., 2008).
Educational programs are frequently described as complex interventions where it is often difficult to define ‘active ingredient(s)’ of these programs. Different factors might influence effectiveness of the PDSME program: skills and motivation of the nurse educator (therapist effect), utilization of group work activities, interactive nature of the education, utilization of visual aids and contribution of theoretical models used in the design and implementation of educational activities, e.g. goal setting. Actual mechanism of action is likely to be a combination of all components. Additional research is needed to answer the important questions of what parts of the intervention are most likely to lead to positive outcomes, assessing mediators and moderators of PDSME intervention's effects.
STUDY LIMITATIONS AND STRENGTHS
The major strength of the study is novelty of current work. To the best of our knowledge, this is the first structured culture-oriented, theory- and evidence-based intervention developed for diabetes in Iran. A benefit of such programs is that health care professionals, who have little contact time, can focus their time more on active management of diabetes, once individuals have attended a program like PDSME. The program is likely to be generalizable to a majority of patients in Farsi-language environments, as we implemented minimum exclusion criteria for the trial.
Our program focused on patients with diabetes; however, there are more individuals at risk of developing diabetes. Future programs may consider similar strategies for reaching at-risk populations. Through the study, we encountered patients who had decided not to refer to clinics, despite having high blood glucose. A variety of reasons should be mentioned such as cost, low risk perception, lack of knowledge and lack of social support. Researchers should find ways to recognize and help hard-to-reach patients.
CONCLUSION
PDSME was effective in improving self-management, cognitive and clinical outcomes. Results support use of intervention mapping for planning effective interventions. Given the high number of individuals with diabetes and lack of affordable diabetes education, PDSME deserves consideration for implementation.
FUNDING
This project was funded by School of Public Health, Tehran University of Medical Sciences (contract no. 240/4719).