Peer Support for Achieving Independence in Diabetes (Peer AID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 主要终点
- Improvement in HbA1c
研究概览
简要总结
The purpose of this study is to test the hypotheses that CHWs providing in-home support for self-management of type 2 diabetes, resources for diabetes, and assistance in effective linkage and communication with medical providers will: (1) improve HbA1c (primary outcome) and secondary outcomes including lipids, blood pressure, health care utilization, and health-related quality of life; (2) improve diabetes self-management, including self-efficacy, physical activity, nutrition, and medication adherence; and (3) be cost-effective and feasible.
详细描述
The investigators will implement a randomized trial that will enroll 286 participants, from three different sites, to compare a CHW intervention consisting of home visits, telephone support, and linkage to appropriate community-based group activities compared to usual care. Usual care is defined as the medical care received by participants in the absence of the intervention plus information about community resources that support diabetes self-management (such as classes and support groups) plus educational pamphlets. The investigators will randomize an equal number of participants to the intervention and control groups.
After collecting baseline data, we will assign participants to study groups using a stratified, permuted block design with varying block size. The investigators will stratify by site to ensure an approximately equal number of treatment and control subjects at each site and also meet the site-specific recruitment targets. The nature of the intervention makes it impossible to blind participants and staff to group assignment.
CHWs will primarily work with participants in their homes, and will also link them to community resources that support self-management. CHWs will make up to 5 home visits for each participant in the intervention arm. To assure that the program is feasible to implement in a variety of clinical settings, to assure external validity of the study, and to assess potential for adoption, the CHWs will be based at the local public health department and participants will be recruited from a county hospital system, a community clinic and a Veteran Affairs (VA) hospital.
Specific aims of the proposal are to examine the effect of the intervention on physiologic markers of disease control (HbA1c, lipids, blood pressure), participant self-efficacy, self-management behaviors quality of life and utilization and costs. The investigators will measure other demographic, medical and psychosocial patient level characteristics that could potentially modify the effects of the intervention. At the end of the study period, CHWs will visit usual care participants so that they receive many of the potential benefits received by intervention group members.
The investigators will use mixed methods to assess translation of the research models into practice.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes and HbA1c of 8.0% or greater
- •Household income less than 250% of the federal poverty level
- •Residence within target area of King County, Washington
- •Age 30-70 years.
- •Primary language spoken by participant is English or Spanish
排除标准
- •Type 1 diabetes
- •Unable to provide informed consent
- •End-stage renal disease (ESRD), dementia, or a terminal illness
- •Plans to move within the next two years or is homeless
- •Other mental or physical disability making it impossible to participate in the protocols
结局指标
主要结局
Improvement in HbA1c
时间窗: One Year
HbA1c will be assessed at baseline and then again at 12 months.
次要结局
- Healthcare Utilization(One Year)
- Improvement in lipids(One Year)
- Physical and mental functioning(One year)
- Improvement in blood pressure(One Year)