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

Not Applicable

Recruiting

• Conditions: Obesity; Cardiovascular Diseases

• Registration Number: NCT06063564
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-02
• Study Start: 2024-08-20
• Status Verified: 2024-09
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fidelity of PREVENT tool implementation	0-6 months	Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.
Patients' satisfaction of PREVENT tool: survey	6-months	A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction.
Provider's satisfaction of PREVENT tool: survey	Up to 12 weeks post-study	A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction.

Secondary Outcome Measures

Name	Time	Method
Quality of health behavior counseling	Immediately following clinic visit	Patient perceptions of the clinical interaction in which CVH and health behaviors will be assessed using a survey (10- questions). Questions are asked as yes/no/I don't' know. Quality counseling will be defined as patient reported yes to their care team: 1) talking to them about healthy food intake; 2) talking to them about physical activity 3) delivering goals and 4) delivering resources.
Change in patient's cholesterol	At baseline, and 6-months	Collected from patient's medical record.
Change in provider confidence: survey	At baseline, and 6-months	Provider confidence in discussing CVH and health behaviors with overweight and obese patients will be assessed using a survey (4-questions). Questions are asked on 5-point Likert scale (range: 4-20) with a higher score indicating greater confidence.
Change in food intake behaviors	At baseline, and 6-months	Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior \& Attitudes Survey.
Change in minutes of moderate to vigorous physical activity	At baseline, and 6-months	Patient-reported physical activity (minutes of moderate and vigorous activity per week) are collected using a survey (4-questions). Patients report the average number of minutes of moderate and vigorous activity they do per week.
Change in patient's blood glucose	At baseline, and 6-months	Collected from patient's medical record.
Change in patient's motivation	At baseline, and 6-months	A survey (15-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 5-point Likert scale (range: 15-75) with a higher score indicating greater motivation.
Change in body mass index (BMI)	At baseline, and 6-months	Collected from patient's medical record.
Change on patient's average systolic and diastolic blood pressure	At baseline, and 6-months	Collected from patient's medical record.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States