Feasibility of diabetes self-management coaching program for individuals with type 2 diabetes in the Ethiopian primary care setting: a protocol for a feasibility mixed-methods parallel-group randomized controlled trial.

Abstract

Diabetes mellitus is the third most prevalent chronic metabolic disorder and a significant contributor to disability and impaired quality of life globally. Diabetes self-management coaching is an emerging empowerment strategy for individuals with type 2 diabetes, enabling them to achieve their health and wellness goals. The current study aims to determine the feasibility of a diabetes self-management coaching program and its preliminary effectiveness on the clinical and psychosocial outcomes in the Ethiopian primary healthcare context. The study will employ a mixed-method feasibility randomized controlled trial design. Forty individuals with type 2 diabetes will be randomly allocated to treatment and control groups using block randomization. The primary feasibility outcomes include acceptability, eligibility, recruitment, and participant retention rates, which will be computed using descriptive analysis. The secondary outcomes are self-efficacy, self-care activity, quality of life, and glycated hemoglobin A1c. For normally distributed continuous variables, the mean difference within and between the groups will be determined by paired sample Student t-test and independent sample Student t-test, respectively. Non-parametric tests such as the Mann-Whitney U test, the Wilcoxon signed rank test, and the Friedman analysis of variance test will determine the median difference for variables that violated the normality assumption. A repeated measure analysis of variance will be considered to estimate the variance between the baseline, post-intervention, and post-follow-up measurements. A sample of 10 volunteers in the treatment group will participate in the qualitative interview to explore their experience with the diabetes self-management coaching program and overall feasibility. The study will follow a qualitative content analysis approach to analyze the qualitative data. Qualitative and quantitative findings will be integrated using a joint display technique. Evidence reveals diabetes self-management coaching programs effectively improve HbA1c, self-efficacy, self-care activity, and quality of life. This study will determine the feasibility of a future large-scale randomized controlled trial on diabetes self-management coaching. The study will also provide evidence on the preliminary outcomes and contribute to improving the diabetes self-management experience and quality of life of individuals with type 2 diabetes. The trial was registered online at ClinicalTrials.gov on 12/04/2022 and received a unique registration number, NCT05336019, and the URL of the registry is https://beta. gov/study/NCT05336019 .