The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.

Study Overview
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Brief Summary
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Background: Diabetes mellitus is the third most prevalent chronic disease globally. It is a metabolic disorder characterized by elevated blood glucose because of impaired insulin production, reduced insulin effectiveness, or both. It is a major contributor for physical disability and impaired quality of life. Diabetic Self-Management programs help to control blood glucose, reduce hospitalization, and increase compliance; however, the program is underutilized in the Primary Care settings globally; due to cognitive, financial, behavioral, and emotional factors. Health coaching is a client-centered self-management approach informed by behavioral change theories to empower individuals to identify their strengths and resources and achieve their health and wellness goals. Purpose: The study's overarching goal is to determine whether implementing the Diabetes Self-Management (DSM) Coaching program can be effective and feasible for individuals with type diabetes in the Ethiopian primary care context. Method: The study will employ a single-blinded feasibility randomized controlled trial followed by a concurrent mixed-method design. A block randomization technique with block size of 4 will be used to allocate eligible participants for the quantitative part. Structured outcome measures will be used to collect data on self-efficacy, self-care practice, and glycated hemoglobin A1c. Qualitative description approach with an in-depth interview method of data collection will be used to explore perspectives of participants, barriers and facilitators, and acceptability of the program. Mean, median and frequencies will be computed. Depending on the normality of the distribution and the number of participants, t-tests, x2 tests, sign tests, and ANOVA will be considered to analyze the data. Inductive qualitative content analysis approach will be followed to analyze qualitative data. Qualitative and quantitative data will be merged at result level for further interpretation and presented in discussion section. Significance: The study will be used to determine the feasibility of the Diabetic Self-Management Coaching program in the Ethiopian primary care settings. Study participants will be benefited from the coaching program and will improve their self-efficacy, diabetes self-care practice, and blood glucose level. Furthermore, the study will have a paramount advantage to establish a foundation for future definitive trial that can prove effectiveness of the program.

Detailed Description
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Primary Aim Objective 2. To determine the acceptability of implementing a DSM Coaching program in the Ethiopian PC setting. The specific objectives are: 1.1. To assess the recruitment ability, adherence, retention ability, and satisfaction of the study participants. 1.2. To determine the fidelity of implementing the DSM Coaching program. Secondary Aim Objective 2. Evaluate the effectiveness of the DSM Coaching program on self-efficacy, self-care practice, and HbA1c among individuals with type 2 diabetes attending PC in Gondar town. The specific objectives include- 2.1. To evaluate the effect of the DSM Coaching program on the self-efficacy of individuals with type 2 diabetes 2.2. To examine the effect of the DSM Coaching program on the self-care practice of individuals with type 2 diabetes. 2..3. To determine the effect of the DSM Coaching program on the HbA1C of individuals with type 2 diabetes. Study participants assigned to intervention group will attend 12 weeks DSM Coaching program. This program has two components, four group based sessions and 4 individual home-based coaching. The control group will take the routine diabetes care for the same duration. The outcome will be assessed at baseline, after completing the intervention and after a two months follow-up.

Official Title
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Effectiveness of the Diabetes Self-management Coaching Program on the Clinical and Behavioral Parameters for Individuals With Type 2 Diabetes in the Ethiopian PC Setting: Mixed-methods Feasibility Randomized Controlled Trial

Conditions
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Type 2 Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Diabetes self-management Coaching
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attend diabetes care for at least 1 year Taking anti-diabetic medications Age between 18 -65 years HbA1c level >7% or Repeated FBS>130 Exclusion Criteria: Attend behavioral therapy program in the last 1 year Clinically confirmed mentally ill clients Pregnant Physically impaired (unable to see, hear, and walk) Clinically confirmed co-morbidity (Heart failure, cancer, stroke) which may interfere with their participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single-blinded, parallel-group feasibility Randomized Controlled Trial design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes self-management Coaching<br>A 12-week Diabetes self-management Coaching program and the usual care | Behavioral: Diabetes self-management Coaching<br>* A 12-week Diabetes self-management coaching program<br>* Other names: Diabetes Health Coaching;|
| Active Comparator: Usual Care<br>The control group will be assigned to 12 weeks usual care or routine diabetes service | Other: Usual care<br>* Assigned to 12 weeks of usual care which includes a physical examination, history taking,, medication refill, lab investigation, and health education<br>* Other names: routine service;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the DSM Coaching program | Acceptability measures the reaction of individual recipients-both study subjects and interventionists to the intervention(Bowen et al., 2009). It will be measured using a validated scale (B. J. Weiner et al., 2017). Mean scores will be used to categorize responses into acceptable and non-acceptable. | up to 1 year | 
| Recruitment rate | It is the proportion of eligible individuals willing to give consent and randomized to the study. | up to 1 year | 
| Ahernece rate | An intervention adherence is the participant's compliance with attending all group sessions, and all home-based coaching sessions. | 1 year | 
| Retention rate | The ability of the program to retain participants in the study. The proportion of study participants who completed the study and evaluated at the end of the intervention T2 and end of follow-up T3. | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes self-efficacy | Diabetes self-efficacy will be measured using Stanford Self-Management Resource Center (SMRC) diabetes self-efficacy scale (SMRC, 2021). Mean scores will be computed to decide changes in values. | up to 1 year | 
| Diabetes self-care practice | The diabetes self-care practice will be measured using the Summary of Diabetes Self-Care Activity (SDSCA)(Toobert et al., 2000). Mean scores will be computed to decide changes in values. | up to 1 year | 
| Glycated Hemoglobin A1c (HbA1c) | HbA1c will be analyzed from a sample of whole blood using a chemistry machine at the University of Gondar hospital laboratory department. HbA1c < 7.0% is considered as the good glycemic control and HbA1c ≥ 7.0% will be considered as poorly controlled glucose level(Abera et al., 2022). | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, self-management, Type 2 Diabetes, Coaching, Empowerment