Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397729
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-01-23
Brief Title:
Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rural PREVENT
Brief Summary:
This project will conduct a pilot hybrid study that examines the implementation Aims 1 2 and preliminary effectiveness Aim 3 of PREVENT a digital health intervention among patients with overweightobesity N100 using a clinic-randomized design The central hypothesis of the study is that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients motivation to change and their CVH health behaviors and outcomes
Detailed Description:
Cardiovascular disease CVD prevalence is 40 higher among rural than urban residents in the United States Maintaining healthy weight physical activity and food intake behaviors promotes cardiovascular health CVH and prevents CVD The Health Resources and Services Administration requires health behavior counseling and follow-up care for patients with elevated body mass index Counseling is most effective when developed with and tailored to the patient and offered with resources that support healthy food intake and physical activity Healthcare teams are challenged by the lack of accessible evidence-based tailored recommendations and limited awareness of patient health behaviors and community resources all of which are compounded by lack of time within the clinical workflow Yet digital health tools that can facilitate quality counseling and follow-up are not readily available for primary care teams - particularly those in low-resourced rural settings The investigators will leverage our existing digital health tool PREVENT for healthcare teams including Community Health Workers CHWs to use at the point-of-care with rural low-income patients who are overweight or obese and often have more severe social needs PREVENT visually displays patient-reported and electronic health record data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources The investigators have been working with the Missouri Highlands Health Care a federally-qualified health center with 10 clinics across 7 rural counties that has an existing CHW network to adapt our tool to meet the needs of their health care teams and patients This project will examine the implementation Aims 1 2 and preliminary effectiveness Aim 3 of PREVENT among patients with overweightobesity N100 using a clinic-randomized design in four clinics The investigators believe that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients motivation to change CVH health behaviors and outcomes The investigators will seek to understand factors impacting implementation and sustainment of this approach to streamline the translation of this tool into routine care Our ultimate goal is to improve CVH with enhanced health behavior counseling and follow-up using a multi-level approach that targets health behaviors and unmet social needs to give everyone an equal opportunity for health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None