ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 主要终点
- LDL cholesterol
研究概览
简要总结
It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an innovative peer coaching intervention plus brief education vs. brief education alone on diabetes outcomes.
详细描述
The purpose of this project was to provide robust evidence on the effectiveness of a peer support intervention in improving diabetes outcomes by conducting a group-randomized, controlled implementation trial of a volunteer peer support intervention.
The study had three specific aims:
Aim 1. In Phase I (months 0-8), to perform a qualitative needs assessment with peer advisors and health care providers to inform peer advisor roles and responsibilities (i.e., the intervention) and peer advisor recruitment strategies, curriculum and training; and patient recruitment plans.
Aim 2. Also in Phase I, to pilot our collaboratively developed intervention and, based on pilot test results, to recruit and train peer advisors for the intervention, and begin patient recruitment.
Aim 3. In Phase II (months 9-32), conduct the group randomized implementation trial and evaluate it using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 or older in age, diagnosed with diabetes, under the care of a doctor
排除标准
- •not community dwelling, less than 19 years old, pregnant, end-stage medical conditions with limited life expectancy, no access to telephone, does not speak english
结局指标
主要结局
LDL cholesterol
时间窗: Change in LDL cholesterol in 12 month
measured using finger stick, spectrophotometer to measure LDL cholesterol
depressive symptoms
时间窗: change in depressive symptoms at 12 months
self-report using Patient Health Questionnaire 8 (PHQ8)
Glycated hemoglobin (A1c)
时间窗: Change in A1c in 12 months
fingerstick, point-of-care a1c test
Blood pressure
时间窗: Change in blood pressure measure in 12 months
Measured using digital automated blood pressure monitor
diabetes self-care behaviors questionnaire
时间窗: Change in diabetes self-care behaviors at 12 months
aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors
patient activation
时间窗: change in patient activation in 12 months
self-report using the 13 item Patient Activation Measure (PAM13)
quality of life
时间窗: Change in quality of life measures at 12 months
self-report using Short form-1 (SF1), and Euroquol (EQ-5D)
次要结局
- body mass index(change in BMI in 12 months)
- composite measure of healthcare utilization(Change in health care utilization in 12 months)
- diabetes knowledge(change in diabetes knowledge in 12 months)
- trust in physicians(change in trust in physicians in 12 months)
研究者
Monika M. Safford
Professor
Weill Medical College of Cornell University
