The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.
Condition: Type 2 Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Diabetes self-management Coaching; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): A 12-week Diabetes self-management coaching program; Assigned to 12 weeks of usual care which includes a physical examination, history taking,, medication refill, lab investigation, and health education
Other intervention name(s): Diabetes Health Coaching; routine service
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-blinded, parallel-group feasibility Randomized Controlled Trial design.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diabetes Mellitus; self-management; Type 2 Diabetes; Coaching; Empowerment