Study design and description of participants
This study was designed as a single-blind, randomized controlled study. Participants were randomized into an intervention group and into a control group. Participants were randomized by using the website of "Research Randomizer/ https://www.randomizer.org/#randomize". Numerical distribution was ensured as formed according to 2 sets and unique numbers per set. Participants were included in the groups according to the number of randomizations corresponding to the order of applications to the clinic.
As such, a total of 86 patients were referred to the study but 10 were then excluded not meet the inclusion criteria. Nine subjects discontinued participation for various reasons in the process and the study was therefore completed with 67 patients (The sample size was designed to use 5% (p = 0.05) Type 1 error, 80% strength through statistical power analysis, and a two-way hypothesis test and consisted of 33 subjects per group). Participants for this study were selected from patients who presented at the internal medicine outpatient department of a state hospital in Turkey. Individuals who had been diagnosed with type 2 diabetes mellitus, were aged between 18 and 65 and were literate in Turkish were included, and those with a diagnosis of mental illness or cancer were excluded. Figure 1 shows the CONSORT flow diagram of the study.
All subjects gave consent after they were provided with verbal and printed information about the project. Our study was conducted in accordance with the Helsinki Declaration (revised in 2013), after ethical approval was obtained (ethic number: GO15/731). The study was conducted between June 2015 and September 2017.
The scales described in detail below were applied to all participants. The patients were assessed at baseline, end of the modules and after 3 months.
Measurements
Socio-demographic and clinical features form: Every participant was asked to complete a form to obtain demographic information such as age, gender, marital status, health-related habits (e.g. smoking, alcohol consumption), body mass index (BMI) and medical history (e.g. monitoring, family history, comorbidity).
Primary outcomes
The Canadian Occupational Performance Measure (COPM): The COPM is based on a semi-structured interview method and helps individuals identify and prioritise activities of importance that they have difficulty in performing (21). Specifically, the COPM is a measure of self-perceived occupational performance areas in self-care, productivity and leisure. First, the importance of each occupation is rated on a 10-point scale where 1 is “not important” and 10 is “extremely important”. Then, the five most important activities are rated for performance from 1 (“do not perform well”) to 10 (“perform very well”) and for satisfaction, also from 1 (“not satisfied”) to 10 (“very satisfied”) (22). The test-retest reliability of the COPM is within the acceptable range; intra-class correlation and obtained coefficients for patients with chronic diseases range from the scores were 0.86 to 0.89 for performance and 0.76 to 0.88 for satisfaction (23-25). The COPM has shown Turkish validity and reliability (26).
Secondary Outcomes
The Diabetes Empowerment Scale (DES): The Diabetes Empowerment Scale (DES) is used in the measurement of diabetes-related psychosocial self-efficacy and consists of 28 items with three subscales: managing the psychosocial aspects of diabetes; assessing dissatisfaction and readiness to change; and setting and achieving diabetes goals (27). Each question is rated between 1 for “strongly disagree” and 5 for “strongly agree” so that higher scores indicate better psychosocial self-efficacy levels. The DES is a valid and reliable scale in Turkish populations (28).
The Brief COPE: The Brief COPE measures strategies for coping with stress and includes 14 two-item subscales that are grouped in two coping strategies: effective (active coping, acceptance, positive reframing, planning, and use of emotional or instrumental support) and ineffective (denial, self-distraction, substance use, behavioural disengagement, venting and self-blame) (29). Each question has a selection range from 1 (“I have not been doing this at all”) to 4 (“I have been doing this a lot”), and the highest subscale score means those coping strategies are used more. These tools are also valid and reliable in Turkish populations (30).
The World Health Organisation’s Five Well-Being Index (WHO-5): The World Health Organisation’s Five Well-Being Index (WHO-5) is used for the psychometric evaluation of emotional well-being, depression, and quality of life. This measure consists of five statements which respondents’ rate on a scale of 0 (“never”) to 5 (“all the time”) considering the last two weeks (31). The raw value, ranging from 0 to 25, is multiplied by four to determine the final score with 0 representing the worst possible well-being and 100 the best. WHO-5 has Turkish validity and reliability (32, 33) and a cut-off of less than 13 has been identified to screen for depression and reduced well-being (34).
Intervention
The type 2 diabetes mellitus (T2DM) intervention programme was developed from an occupational therapy perspective; it is a person-centred and occupation-based approach designed. In this study, the intervention was conducted in 6 modules totally in 6 sessions, and each was performed for approximately 60 minutes.
Module 1: The aim of the first session was the definition of the problems and completed the measurement questionnaires. For which participants were asked to keep a diary for a once; how to complete the diary for a typical day was also explained. Problem-solving therapy's first step includes setting as a measurable, realistic and attainable goal for the solution (35). The therapist and participants identified together problematic activities with COPM. The COPM allowed them to identify performance problems in their meaningful activities.
Module 2: The intervention group was provided with education including information about diabetes mellitus. This educational information follows the National Standards for Diabetes Self-Management (36) and is based on a Person-Environment-Occupation Model (37). We, therefore, focused on therapeutic lifestyle changes to include basic knowledge and skills relating to diabetes as well as personal, environmental and occupational factors that affect the condition. The emphasis was on the elements of daily life that could support or prevent effective diabetes management and the importance of determining them.
Module 3: This session included the generation of alternatives and defining possible solution strategies (35). To determine the best strategy for overcoming the obstacles, alternative solutions were explored through brainstorming, and an action plan was created once the most appropriate approach had been identified. The individual was encouraged to recognize and use their environmental and personal resources. In addition, the completed diary was used to determine steps of action plans' time, frequency and duration when deciding daily schedules adaptation.
Module 4-5: These sessions aimed at the implementation and verification of the solution (35). The action plan was then reviewed, and the patient’s experiences shared with the therapist. They discussed together when carried out the solution plan, the individual, environmental, supportive and preventive factors, consequences of the plan and whether problem-solving efforts had been successful or need to revision.
Sample questions of sharing of the action plan experience: What were opportunities or obstacles in the action plan experience, How the individual approached unpredictable developments, Which events were coped with a good or bad way, How could it be possible to reach the target in a different way? The action plan was repeatedly revised to consider individuals' requirements.
Module 6: The last session included the sharing of experiences and the discussion of future goals, in addition, all questionnaires were reapplied.
Statistical method
Data were analysed using IBM the Statistical Package for the Social Sciences (SPSS) version 21.0 software (38). The Shapiro-Wilk Test was used to evaluate the distribution of the collected data (normal = p > .05, not normal = p < .05). The Chi-Square and Mann Whitney U test was used for the differences in demographic variables between the groups (p < .05). Differences between the groups were analysed with Independent T-Tests (parametric) or Mann Whitney U test (non-parametric). Group-time interaction differences (i.e. baseline, after six modules and after three months) were calculated by Friedman Test. The level of significance was set at 0.05. Categorical variables were expressed as mean ± standard deviation (X ± SD), and categorical data were described with percent (%) values.
Thematic analysis was used to evaluate the qualitative data of activities (COPM) and presented as percentages (%). Coding was conducted with MAXQDA 11.0 (39) through which the qualitative data were coded as self-care, productivity or leisure to develop a picture of occupational performance across all areas of life.