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

December 19, 2023 updated by: Fikadu Yehualashet, Queen's University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fikadu A Yehualashet, Mph/Masters
  • Phone Number: +1 6134492940
  • Email: 19fay@queensu.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7K 1N6
        • Fikadu Ambaw Yehualashet
        • Contact:
          • Fikadu A Yehualashet, Masters
          • Phone Number: +251 918700504
          • Email: 19fay@queensu.ca
        • Contact:
        • Principal Investigator:
          • Fikadu A Yehualashet, Masters
        • Sub-Investigator:
          • Dorothy Kessler, PhD
        • Sub-Investigator:
          • Segenet Bizuneh, MD, internist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the DSM Coaching program
Time Frame: up to 1 year
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
Time Frame: up to 1 year
It is the proportion of eligible individuals willing to give consent and randomized to the study.
up to 1 year
Ahernece rate
Time Frame: 1 year
An intervention adherence is the participant's compliance with attending all group sessions, and all home-based coaching sessions.
1 year
Retention rate
Time Frame: 1year
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
Time Frame: up to 1 year
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
Time Frame: up to 1 year
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)
Time Frame: up to 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

University of Gondar

Investigators

  • Principal Investigator: Fikadu A Yehualashet, Masters, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20224207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For the sake of confidentiality, participant data will not be shared. However, data will be disseminated in the form of publications, conference presentations, and local media. In addition, data may be shared on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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