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

Обзор

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.

Вмешательства

• Поведенческое PREVENT
  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.
• Поведенческое Wait-list Control
  Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool.

Первичные конечные точки

• Patients' satisfaction of PREVENT tool: survey [Срок оценки: 6-months]
• Provider's satisfaction of PREVENT tool: survey [Срок оценки: Up to 12 weeks post-study]
• Fidelity of PREVENT tool implementation [Срок оценки: 0-6 months]

Вторичные конечные точки (9)

• Change in provider confidence: survey [Срок оценки: At baseline, and 6-months]
• Quality of health behavior counseling [Срок оценки: Immediately following clinic visit]
• Change in patient's motivation [Срок оценки: At baseline, 3 months and 6-months]
• Change in food intake behaviors [Срок оценки: At baseline, 3 months and 6-months]
• Change in minutes of moderate to vigorous physical activity [Срок оценки: At baseline, 3 months and 6-months]
• Change in body mass index (BMI) [Срок оценки: At baseline, and 6-months]
• Change on patient's average systolic and diastolic blood pressure [Срок оценки: At baseline, and 6-months]
• Change in patient's cholesterol [Срок оценки: At baseline, and 6-months]
• Change in patient's blood glucose [Срок оценки: At baseline, and 6-months]

Критерии участия

Критерии включения

• Aged 18-64 years at baseline
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Washington University in St. Louis — St Louis

Идентификаторы

NCT: NCT06063564 · 202307156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗