Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06063564
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • PREVENT — BEHAVIORAL
    PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
  • Wait-list Control — BEHAVIORAL
    Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool.

Study Details

The focus on this application is low-income, rural patients, since cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents. Health behavior counseling and follow-up care are required for patients with an elevated body mass index who have increased risk for CVD. Counseling is most effective when developed with, and tailored to, the patient and offered with resources that support healthy food intake and physical activity. Resource referral and follow-up is particularly important in rural low income residents who often have more severe social needs that impede healthy behaviors. The proposed research will leverage the candidate's digital health tool (PREVENT) for healthcare teams to use within the clinic visit. PREVENT visually displays patient-reported and electronic health record (EHR) data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. PREVENT may improve the quality of required care and promote cardiovascular health equity. This research will: 1) collaborate with rural and clinic partners to modify and integrate the PREVENT tool for low-income, rural patients with obesity (Aim 1); and 2) conduct a pilot pragmatic clinical trial of PREVENT to optimize feasibility, acceptability, appropriateness, and potential health equity impact.

Key Dates

Start date
Aug 20, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Wait-List Control
    Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following their clinic visit and at 6-months after the clinic visit electronically and by mail. A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.
  • Experimental: PREVENT Intervention
    Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 6-months after the clinic visit electronically and by mail At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk. A community health worker (CHW) will deliver a tailored behavioral change plan inclusive of patient-centered community resources. The CHW will provide ongoing support with goals and social needs for 6-months.

Primary Outcome Measure

Patients' satisfaction of PREVENT tool: survey [ Time Frame: 6-months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63130
Maura M Kepper, PhD
[email protected]
3149350142

Find similar trials in St Louis, MO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Washington University in St. Louis· St Louis, MO

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