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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of the DSM Coaching program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attend diabetes care for at least 1 year
- •Taking anti-diabetic medications
- •Age between 18 -65 years
- •HbA1c level >7% or Repeated FBS>130
排除标准
- •Attend behavioral therapy program in the last 1 year
- •Clinically confirmed mentally ill clients
- •Physically impaired (unable to see, hear, and walk)
- •Clinically confirmed co-morbidity (Heart failure, cancer, stroke) which may interfere with their participation
研究组 & 干预措施
"Diabetes self-management Coaching"
A 12-week Diabetes self-management Coaching program and the usual care
干预措施: Diabetes self-management Coaching (Behavioral)
"Usual Care"
The control group will be assigned to 12 weeks usual care or routine diabetes service
干预措施: Usual care (Other)
结局指标
主要结局
Feasibility of the DSM Coaching program
时间窗: 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.
Recruitment rate
时间窗: up to 1 year
It is the proportion of eligible individuals willing to give consent and randomized to the study.
Ahernece rate
时间窗: 1 year
An intervention adherence is the participant's compliance with attending all group sessions, and all home-based coaching sessions.
Retention rate
时间窗: 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.
次要结局
- Glycated Hemoglobin A1c (HbA1c)(up to 1 year)
- Diabetes self-efficacy(up to 1 year)
- Diabetes self-care practice(up to 1 year)
研究者
Fikadu Yehualashet
Mr.
Queen's University