跳至主要内容
临床试验/NCT02460718
NCT02460718已完成不适用

ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama

Weill Medical College of Cornell University0 个研究点目标入组 424 人开始时间: 2009年2月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monika M. Safford

Professor

Weill Medical College of Cornell University

相似试验

ENCOURAGE: Evaluating Community Peer Advisors and... | 临床试验