Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fidelity of PREVENT tool implementation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Wait-list Control (Behavioral)
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.
干预措施: PREVENT (Behavioral)
结局指标
主要结局
Fidelity of PREVENT tool implementation
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in provider confidence: survey(At baseline, and 6-months)
- Quality of health behavior counseling(Immediately following clinic visit)
- Change in body mass index (BMI)(At baseline, and 6-months)
- Change on patient's average systolic and diastolic blood pressure(At baseline, and 6-months)
- Change in patient's cholesterol(At baseline, and 6-months)
- Change in patient's blood glucose(At baseline, and 6-months)
- Change in provider confidence: survey(At baseline, and 6-months)
- Quality of health behavior counseling(Immediately following clinic visit)
- Change in patient's motivation(At baseline, 3 months and 6-months)
- Change in food intake behaviors(At baseline, 3 months and 6-months)
- Change in minutes of moderate to vigorous physical activity(At baseline, 3 months and 6-months)
- Change in body mass index (BMI)(At baseline, and 6-months)
- Change on patient's average systolic and diastolic blood pressure(At baseline, and 6-months)
- Change in patient's cholesterol(At baseline, and 6-months)
- Change in patient's blood glucose(At baseline, and 6-months)