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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Aged 18-64 years at baseline

• low-income (household income \<200% poverty)

• a BMI ≥ 30

• Receiving care from the Missouri Highlands.

• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Locations
United States
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov