Clinical trial NCT05336019: The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
self-management
Type 2 Diabetes
Coaching
Empowerment
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded, parallel-group feasibility Randomized Controlled Trial design.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the DSM Coaching program
timeFrame: up to 1 year
measure: Recruitment rate
timeFrame: up to 1 year
measure: Ahernece rate
timeFrame: 1 year
measure: Retention rate
timeFrame: 1year
Secondary outcomes:
measure: Diabetes self-efficacy
timeFrame: up to 1 year
measure: Diabetes self-care practice
timeFrame: up to 1 year
measure: Glycated Hemoglobin A1c (HbA1c)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Fikadu Ambaw Yehualashet
state: Ontario
Study officials:
affiliation: Queen's University
name: Fikadu A Yehualashet, Masters
role: PRINCIPAL_INVESTIGATOR
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