Other Clinical Trial - vDPP Facilitated With Community Care Coordination

Status Active, not recruiting

Clinical Trial Summary

The goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). The goal of the intervention is to improve body weight, blood pressure, diet quality, and physical activity levels among low-income individuals at risk for type 2 diabetes.

Clinical Trial Description

Specific aims and hypotheses: 1. Conduct formative research with community partners (via focus groups and interviews with key stakeholders and a small pilot) to assess community, systemic, technology, and structural level barriers to implementation of a virtually-delivered Diabetes Prevention Program. Hypothesis: These efforts will identify individual and community needs, barriers, and resources affecting the feasibility of v-DPP implementation. In addition, strategies for facilitating the delivery of the v-DPP to low-income communities will be developed. 2. In collaboration with community partners, utilize strategies identified in Aim A1 to maximize impact of the v-DDP in target communities, as evidenced by measures of reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) and assess factors influencing RE-AIM outcomes (e.g. social determinants of health, demographic variables, self-efficacy). Hypothesis: The v-DPP facilitated by community-based care coordination will produce favorable RE-AIM outcomes. Factors influencing these outcomes will be explored as well. 3. Demonstrate improvements in body weight, blood pressure, diet quality, and physical activity in low-income individuals at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination. Hypothesis: The v-DPP, facilitated by community-based care coordination provided by CHWs and HCNs, will improve body weight, blood pressure, diet quality, and physical activity levels in the study communities. 4. Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP facilitated by community-based care coordination in the study communities and translate it to other community settings. Hypothesis: The implementation approach will be packaged, including strategies for implementation in different settings and related costs, providing a process for implementation in other low-income communities in our region and nationally. ;

Study Design

Related Conditions & MeSH terms

Diabetes Prevention

Clinical Trial Details

NCT number	NCT04195477
Study type	Interventional
Source	Yale University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 7, 2020
Completion date	July 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.