ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama (ENCOURAGE)
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 19 or older in age, diagnosed with diabetes, under the care of a doctor
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：control group
Participants received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit.
Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight.
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实验性的：Encourage study
Participants in the intervention arm were paired with a peer coach, interacting by telephone weekly for the first 8 weeks and then monthly for a total of 10 months. Participants also received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight. |
This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Glycated hemoglobin (A1c)
大体时间：Change in A1c in 12 months
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fingerstick, point-of-care a1c test
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Change in A1c in 12 months
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Blood pressure
大体时间：Change in blood pressure measure in 12 months
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Measured using digital automated blood pressure monitor
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Change in blood pressure measure in 12 months
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LDL cholesterol
大体时间：Change in LDL cholesterol in 12 month
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measured using finger stick, spectrophotometer to measure LDL cholesterol
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Change in LDL cholesterol in 12 month
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diabetes self-care behaviors questionnaire
大体时间：Change in diabetes self-care behaviors at 12 months
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aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors
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Change in diabetes self-care behaviors at 12 months
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depressive symptoms
大体时间：change in depressive symptoms at 12 months
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self-report using Patient Health Questionnaire 8 (PHQ8)
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change in depressive symptoms at 12 months
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quality of life
大体时间：Change in quality of life measures at 12 months
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self-report using Short form-1 (SF1), and Euroquol (EQ-5D)
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Change in quality of life measures at 12 months
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patient activation
大体时间：change in patient activation in 12 months
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self-report using the 13 item Patient Activation Measure (PAM13)
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change in patient activation in 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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body mass index
大体时间：change in BMI in 12 months
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weight measured using digital scale, height measured using stadiometer
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change in BMI in 12 months
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diabetes knowledge
大体时间：change in diabetes knowledge in 12 months
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assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale
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change in diabetes knowledge in 12 months
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trust in physicians
大体时间：change in trust in physicians in 12 months
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assessed using the Trust in Physicians Scale
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change in trust in physicians in 12 months
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composite measure of healthcare utilization
大体时间：Change in health care utilization in 12 months
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self-report by participant, number of times utilized healthcare services
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Change in health care utilization in 12 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
糖尿病的临床试验
ENCOURAGE Study的临床试验
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Hospital Clinic of BarcelonaUniversitat Politècnica de Catalunya; Institut Catala de Salut; Department of Health, Generalitat... 和其他合作者未知