The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.
NCT ID: NCT05336019
Last Updated: 2023-12-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-01
Study Completion Date
2023-04-30
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.
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.
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.
Conditions
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Type 2 Diabetes
Diabetes Mellitus, Type 2
Keywords
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Diabetes Mellitus
self-management
Type 2 Diabetes
Coaching
Empowerment
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A single-blinded, parallel-group feasibility Randomized Controlled Trial design.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
Outcome assessors will be masked not be aware of the random assignment of study participants. Trained outcome assessors who are working in health facilities where participants are not selected will be recruited and involved in the data collection once either in baseline or end line evaluation.
Study Groups
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"Diabetes self-management Coaching"
A 12-week Diabetes self-management Coaching program and the usual care
Group Type
EXPERIMENTAL
Diabetes self-management Coaching
Intervention Type
BEHAVIORAL
A 12-week Diabetes self-management coaching program
"Usual Care"
The control group will be assigned to 12 weeks usual care or routine diabetes service
Group Type
ACTIVE_COMPARATOR
Usual care
Intervention Type
OTHER
Assigned to 12 weeks of usual care which includes a physical examination, history taking,, medication refill, lab investigation, and health education
Interventions
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Diabetes self-management Coaching
A 12-week Diabetes self-management coaching program
Intervention Type
BEHAVIORAL
Usual care
Assigned to 12 weeks of usual care which includes a physical examination, history taking,, medication refill, lab investigation, and health education
Intervention Type
OTHER
Other Intervention Names
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Diabetes Health Coaching
routine service
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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Queen's University
OTHER
Sponsor Role
lead
Responsible Party
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Fikadu Yehualashet
Mr.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Fikadu A Yehualashet, Masters
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Fikadu Ambaw Yehualashet
Kingston, Ontario, Canada
Site Status
Countries
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Canada
References
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Reference Type
DERIVED
Other Identifiers
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20224207
Identifier Type: -
Identifier Source: org_study_id