Study design

The study was a single-center, randomized controlled trial conducted from July to December 2020. The ethics committee of the Iran University of Medical Sciences approved the study (IR.IUMS.REC1396.9321525002) and all procedures were performed by relevant guidelines and regulations. The research was also registered in the Iran Clinical Trials Center (IRCT20180105038224N1) on 02/12/2018.

Participants

To recruit the participants, we used a simple non-probability sampling method by preparing a list of patients with diabetes who had been admitted to the Institute of Endocrinology and Metabolism affiliated with the Iran University of Medical Sciences, Tehran, Iran. Then, we invited the eligible individuals to participate in the study by phone calls. The inclusion criteria were: a diagnosis of type-2 diabetes for at least 1 year, being 30–65 years old, and absence of disabling comorbidities that prevented them from participating in the study. Also, the subjects needed the ability to read and write and showing a HbA1C level higher than 8% based on the laboratory test performed over the previous month. Any occurrence of acute medical conditions or the unwillingness of the participants to continue their participation in the study was the criteria for their exclusion from the research. Written informed consent was obtained from all participants before entering the study.

Randomization and subject allocation

Eligible participants were randomly assigned equally to either an intervention or a control group (N = 15), based on a stratified permuted block randomization from a table of random numbers. Stratification was based on gender and age (≤ 47 years or ≥ 47 years). The research team concealed the intervention plan from the person who assessed the study outcomes.

Intervention

The OTDSM intervention

Interventionstructure and schedule

The intervention group received the OTDSM which involved a combination of individual and group sessions, both face-to-face, and remote ones. The program started with an individual face-to-face session lasted about 45 min, then continued with four face-to-face group meetings took approximately 120–150 min, and five individualized and mostly remotely ones provided weekly over ten consecutive weeks. The face-to-face sessions were held at the School of Rehabilitation of Iran University of Medical Sciences, while the remote sessions were conducted via phone calls. The participants’ family members could also participate in the program, if necessary.

The outbreak of COVID-19 at the time of the study caused the research team to provide the participants transportation to attend the in-person sessions. The subjects in the intervention group were also randomly divided into two subgroups of 7 and 8 persons each. These subgroups had their meetings separately in a large hall.

Intervention contents

A Ph.D. candidate in occupational therapy with ten years of clinical experience provided the intervention. The program started out with an individual face-to-face session, during which the IP used a collaborative and client-centered approach to establish a proper therapeutic relationship with the participants. The main focus was to identify the subjects’ concerns and priorities and review their daily activities. This session continued with counseling and motivational interviewing to trigger the individuals’ motivation to improve upon their daily routines. The evidence-based educational contents of the intervention^26,27 were then shared with the subjects during four consecutive face-to-face group sessions. These included preparing and eating healthy foods, exercising and physical activity, taking medication, caring for their feet, doing regular follow-ups, monitoring self for blood glucose levels and diabetes complications, controlling one’s emotions, expanding social networks, and having or developing intimate relationships. The teaching materials included a PowerPoint presentation with clear illustrations and highlighted texts plus instructional handouts. The group meetings also let the IP facilitate the participants’ sharing of their DSM participation experiences with peers, improving their motivation to plan new daily routines and learn how to solve their problems.

Based on the provided information on each session, the participants set their goals toward their participation in DSM activities. The subjects then wrote an activity diary to include their individual goals and implement the new daily schedules. Accordingly, they practiced the planned health-related activities, adjusted their daily routines, and tried to develop new habits to make progress and succeed in DSM activities. To facilitate the subjects’ participation, the IP continuously reviewed the individuals’ activity patterns during the group and individual sessions. Accordingly, she applied appropriate strategies to facilitate their participation in DSM¹¹. Table 4 describes the intervention contents and strategies and provides examples of the participants’ practiced skills.

The group sessions were conducted followed by five individualized ones, mostly by phone calls. These sessions were conducted by the IP based on the final goal-setting plans and the daily schedules of each participant, which were given to the IP at the last group meeting. Each phone call lasted about 15 min, during which the IP reviewed the daily plan of each participant and answered their questions while noted the changes made in their plan. Accordingly, she guided the participants to establish new daily routines by repeating DSM activities. Two individualized face-to-face sessions were held as remote phone calls could not meet some of the needs of two of the participants; each lasted about 30 min.

Diabetes self-management education

The control group received an individually delivered educational program, provided at the Institute of Endocrinology and Metabolism of Iran University of Medical Sciences, Tehran, Iran. In this program, the IP handed an educational booklet to each participant and briefly reviewed its contents in 20 min. The booklet covered principles of nutrition, exercise, emotional management, diet, diabetes medication, and the need for regular follow-ups. Next, the IP called each of the participants once a week for three consecutive weeks to answer their questions and encourage them to engage in diabetes management activities.

Outcomes

Biological parameters

All biological parameters were measured before the first intervention (T1) and three months later (T3) by collecting a 12-h fasting blood sample from each participant at the laboratory of the Institute of Endocrinology and Metabolism of Iran University of Medical Sciences. The primary data collected were the participants’ levels of HbA1C, measured on an ion-exchange chromatography equipment (DS5 Analyzer, Drew Scientific Limited, Cumbria, UK). Also, the FBS was measured on a glucose analyzer (YSI 2700 Select, YSI, Inc., Yellow Springs, OH). The subjects’ lipid profile was also measured on an auto-analyzer (Liasys, AMS, Italy). This included the blood levels of triglyceride (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL).

Self-reported measures

The self-reported parameters were taken three times, once before the first intervention visit (T1), one month into the study (T2), which was at the end of face-to-face group sessions, and two months later (T3), which was at the end of the 10-week treatment period. These measures are as the following:

Self-management behaviors

A DSMQ^15,28 was used to assess the subjects’ perception of their participation in activities related to diabetes management. The questionnaire covered four areas, such as blood glucose management, diet control, physical activity, and healthcare issues. It contained 16 items, with seven of them worded positively with the other nine worded negatively. The subjects rated each item based on a four-point Likert scale, from zero (not applicable to them) to three (very much applicable to them). The questionnaires were scored based on the following formula:

Accordingly, a score closer to ten was interpreted as being a more desirable self-management behavior than a smaller score¹⁵.

Self-efficacy in diabetes

The DMSES^29,30, a 20-item questionnaire based on Bandura’s self-efficacy concept, was used to assess the subjects’ confidence in their ability to manage diabetes. The participants rated each question based on a five-point Likert scale from one (no, surely not) to 5 (yes, surely) (29). The questionnaire’s scoring involved calculating the mean total and the average scores for each subscale of specific nutrition, general nutrition, blood glucose control, physical activity and weight control, and medical management³⁰.

Diabetes distress

The DDS^31,32 is a 17-item questionnaire to assess the subject’s burdens and worries of living with diabetes and its’ management. The questionnaire contained four subscales to measure negative emotional burdens (emotional subscale), concerns about having a trusted physician and receiving appropriate support and care (physician subscale), worries related to diet, physical activity, and medication (diet subscale), and concerns about receiving appropriate support from family and friends (interpersonal subscale). The subjects rated each question on a six-point Likert scale, from one (not a problem) to 6 (serious problem)³³. The scoring was done by calculating the mean total and the subscale scores. A score less than 2 indicated little or no distress, between 2 and 2.9 signified moderate distress, and 3 or higher indicated high distress³¹.

Depressive symptoms

The PHQ-8^34,35 is an appropriate tool for identifying symptoms of depression in various populations, including people with diabetes. The subjects scored each of the eight questions on the following scale: 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). The scoring system of this questionnaire is the sum of the scores for the questions, from zero to 24. A score between zero and four indicates no symptoms of depression, a score between 5 and 9 implies mild depression, a score between 10 and 14 signifies moderate depression, a score between 15 and 19 represents moderately severe depression, and a score between 20 and 24 indicates severe depression²⁵.

Performance and satisfaction with daily activities

The COPM^19,36,37 was used to assess the subjects’ perception of their performance and satisfaction with important daily activities, such as conducting one’s occupation. Using a client-centered perspective and through semi-structured interviews, this tool allows for a detailed assessment of daily activities in the areas of self-care, productivity, and leisure. The evaluation begins with an open-ended question asked of the subjects to explain what they do on a typical day and if there are any activities that they need or want to do and have difficulty doing. They then prioritize the most important problems in performing their daily activities and rate both their performance and satisfaction with every activity on a scale from one to ten. The scoring involves calculating the mean scores of performance and satisfaction with the activities determined by the individual. Accordingly, a higher score indicates better performance in daily activities and greater satisfaction with participation in these activities¹⁹. The scale has acceptable reliability among people with chronic diseases³⁷ and noticeable content validity for its’ Persian translation³⁶.

Statistical analyses

Power analysis

Thirty people with diabetes participated in this study, with 15 persons in each of the two groups. A one-tailed power calculation of the data collected at the T3 time point showed that the sample size was sufficient to maintain an 82% power and 95% confidence interval for detecting significant between-group differences for the primary outcome (HbA1C) at follow-ups compared to the baseline (G-Power software³⁸).

Data analysis

To describe the quantitative and qualitative variables, respectively, the means plus standard deviations or the numbers plus the percentages were used. The normal distribution of the quantitative variables was examined by the Shapiro–Wilk test at a significance level of 0.01. The Chi-square test and Fisher’s exact test were used to evaluate the homogeneity of the qualitative variables between the two groups. Independent t-tests and Mann Whitney U tests were used for between-group comparisons of the data collected at different time points. The repeated measures analysis of variance (ANOVA) was used for the between-group comparisons by matching the main effect of time with the interaction effect of the group by time. The Bonferroni post hoc test was used to obtain within-group pairwise comparisons at different time points. The data analysis was performed using the SPSS software, version 18, at a significance level of 0.05.