Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- PRx redemption
研究概览
简要总结
Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. There is a critical need for scalable, evidence-based implementation strategies for improving PRx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. This study will co-design and pilot a community health worker (CHW) strategy and test the effectiveness of the strategy compared to PRx participants without a CHW. The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve uptake of a PRx, among Hispanic Medicaid-eligible patients with T2D in Connecticut (CT). CHWs will offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.
详细描述
This study will have a small pilot followed by a randomized controlled trial. The focus of this registration is the randomized controlled trial.
First, following community co-design of the CHW strategy, investigators will conduct a two-month pilot study with an anticipated 10 participants to test the CHW strategy, the produce prescription program Rx, and overall study procedures. All participants will receive the PRx program with CHW strategy for two months.
Second, a randomized controlled trial to evaluate the effectiveness of the CHW strategy on barriers to PRx uptake, level of PRx engagement, and short-term program, behavioral, and health outcomes will be conducted.
Investigators hypothesize that participants who receive added CHW support during their enrollment in the PRx program will have reduced barriers to PRx uptake, higher PRx uptake, and greater improvements in the defined short-term program outcomes compared with participants who do not receive the CHW support during their enrollment in the PRx.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a current primary or specialty care patient at Hartford Hospital
- •Live in Hartford County
- •Identify as Hispanic
- •Have a current diagnosis of Type II Diabetes
- •Be eligible for Medicaid based on household income and size.
排除标准
- •Does not speak English or Spanish
- •Has a diagnosis of gestational diabetes
- •Individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent.
- •Participants who are pregnant will be eligible for the study if they meet all of the inclusion criteria and do not have any of the exclusion criteria, as the study activities (additional funds to purchase fruits and vegetables, nutrition education, and support from a Community Health Worker) does not pose any additional risk to this group.
研究组 & 干预措施
PRx without the CHW strategy
Participants in this group will participate in the PRx without the use of CHWs
干预措施: PRx Program (Behavioral)
PRx with the CHW strategy
Participants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.
干预措施: Community health worker (CHW) strategy (Behavioral)
PRx with the CHW strategy
Participants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.
干预措施: PRx Program (Behavioral)
结局指标
主要结局
PRx redemption
时间窗: Monthly, beginning 1 month after the study start though the end of the six month study period.
PRx redemption is defined as produce debit card dollars used/total dollars available will be collected from the produce debit card platform.
次要结局
- PRx uptake: Attendance(6 months)
- Barriers to PRx uptake(3 months, 6 months)
- PRx uptake: Usage(6 months)
- PRx uptake: Initiation(6 months)
- Change in Fruit and Vegetable Intake(baseline, 3 months, and 6 months)
- Change in Self-rated Health(baseline, 3 months, and 6 months)
- Program Satisfaction(6 months)
- Change in Household Food Insecurity(baseline, 3 months, and 6 months)
- Change in Glycemic control(baseline and 6 months)