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

NCT05336019 | Completed DMC

• 1 other identifier: 20224207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; self-management; Type 2 Diabetes; Coaching; Empowerment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Diabetes self-efficacy

  up to 1 year

• Diabetes self-care practice

  up to 1 year

• Glycated Hemoglobin A1c (HbA1c)

  up to 1 year

Study Arms (2)

"Diabetes self-management Coaching"

EXPERIMENTAL

A 12-week Diabetes self-management Coaching program and the usual care

Behavioral: Diabetes self-management Coaching

"Usual Care"

ACTIVE COMPARATOR

The control group will be assigned to 12 weeks usual care or routine diabetes service

Other: Usual care

Interventions

Diabetes self-management Coaching BEHAVIORAL

A 12-week Diabetes self-management coaching program

Also known as: Diabetes Health Coaching

"Diabetes self-management Coaching"

Usual care OTHER

Assigned to 12 weeks of usual care which includes a physical examination, history taking,, medication refill, lab investigation, and health education

Also known as: routine service

"Usual Care"

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attend diabetes care for at least 1 year
• Taking anti-diabetic medications
• Age between 18 -65 years
• HbA1c level \>7% or Repeated FBS\>130

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Fikadu Ambaw Yehualashet

Kingston, Ontario, K7K 1N6, Canada

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Empowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior

Study Officials

• Fikadu A Yehualashet, Masters

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Model Details: A single-blinded, parallel-group feasibility Randomized Controlled Trial design.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 20, 2022
• Study Start: October 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)