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.clinicaltrials.gov/study/NCT05336019 .

中文翻译：

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埃塞俄比亚初级保健机构中 2 型糖尿病患者糖尿病自我管理辅导计划的可行性：可行性混合方法平行组随机对照试验方案

糖尿病是第三大流行的慢性代谢性疾病，也是全球残疾和生活质量受损的重要原因。糖尿病自我管理辅导是一种针对 2 型糖尿病患者的新兴赋权策略，使他们能够实现健康和保健目标。目前的研究旨在确定糖尿病自我管理辅导计划的可行性及其对埃塞俄比亚初级医疗保健环境中临床和心理社会结果的初步有效性。该研究将采用混合方法可行性随机对照试验设计。 40 名 2 型糖尿病患者将通过分组随机化被随机分配到治疗组和对照组。主要可行性结果包括可接受性、资格、招募和参与者保留率，这些将使用描述性分析进行计算。次要结果是自我效能、自我护理活动、生活质量和糖化血红蛋白 A1c。对于正态分布的连续变量，组内和组间的平均差异将分别通过配对样本学生 t 检验和独立样本学生 t 检验来确定。非参数检验（例如 Mann-Whitney U 检验、Wilcoxon 符号秩检验和 Friedman 方差分析检验）将确定违反正态性假设的变量的中位数差异。将考虑重复测量方差分析来估计基线、干预后和随访后测量之间的方差。治疗组中的 10 名志愿者将参加定性访谈，以探讨他们对糖尿病自我管理辅导计划的体验和整体可行性。该研究将遵循定性内容分析方法来分析定性数据。将使用联合显示技术整合定性和定量研究结果。有证据表明，糖尿病自我管理辅导计划可有效改善 HbA1c、自我效能、自我护理活动和生活质量。这项研究将确定未来针对糖尿病自我管理辅导进行大规模随机对照试验的可行性。该研究还将提供初步结果的证据，并有助于改善 2 型糖尿病患者的糖尿病自我管理经验和生活质量。该试验于2022年4月12日在ClinicalTrials.gov上在线注册，并获得了唯一的注册号NCT05336019，注册网址为https://beta.clinicaltrials.gov/study/NCT05336019。