Clinical trial NCT06063564: Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics
Official title: Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinic randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Patients' satisfaction of PREVENT tool: survey
timeFrame: 6-months
measure: Provider's satisfaction of PREVENT tool: survey
timeFrame: Up to 12 weeks post-study
measure: Fidelity of PREVENT tool implementation
timeFrame: 0-6 months
Secondary outcomes:
measure: Change in provider confidence: survey
timeFrame: At baseline, and 6-months
measure: Quality of health behavior counseling
timeFrame: Immediately following clinic visit
measure: Change in patient's motivation
timeFrame: At baseline, and 6-months
measure: Change in food intake behaviors
timeFrame: At baseline, and 6-months
measure: Change in minutes of moderate to vigorous physical activity
timeFrame: At baseline, and 6-months
measure: Change in body mass index (BMI)
timeFrame: At baseline, and 6-months
measure: Change on patient's average systolic and diastolic blood pressure
timeFrame: At baseline, and 6-months
measure: Change in patient's cholesterol
timeFrame: At baseline, and 6-months
measure: Change in patient's blood glucose
timeFrame: At baseline, and 6-months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References: