Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05336019
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2022-04-06
Brief Title:
The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC
Sponsor:
Queens University
Organization:
Queens University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Primarycare
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 studys 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 studys 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
11 To assess the recruitment ability adherence retention ability and satisfaction of the study participants
12 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- 21 To evaluate the effect of the DSM Coaching program on the self-efficacy of individuals with type 2 diabetes 22 To examine the effect of the DSM Coaching program on the self-care practice of individuals with type 2 diabetes
23 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
11 To assess the recruitment ability adherence retention ability and satisfaction of the study participants
12 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- 21 To evaluate the effect of the DSM Coaching program on the self-efficacy of individuals with type 2 diabetes 22 To examine the effect of the DSM Coaching program on the self-care practice of individuals with type 2 diabetes
23 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None