NCT06121193

Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

Completed NA Last updated 9 November 2023

What this trial tests

NA trial testing PREVENT tool in Cardiovascular Diseases in 36 participants. Completed in 31 August 2021.

Timeline

1 June 2020

Primary endpoint
31 August 2021

31 August 2021

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	36
Start date	1 June 2020
Primary completion	31 August 2021
Estimated completion	31 August 2021
Sites	1 location across United States

Drugs / interventions tested

• PREVENT tool
• Wait-list Control

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Obesity — all drugs for Obesity →

Sponsor

Washington University School of Medicine

Who can join

Adults 12 to 17, any sex, with Cardiovascular Diseases or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Impact of Behavior Change Counseling Delivered via a Digital Health Tool Versus Routine Care Among Adolescents With Obesity: Pilot Randomized Feasibility Study.
   Kepper M, Walsh-Bailey C, Miller ZM, Zhao M, et al · · 2024 · cited 2× · PMID 38758581 · DOI 10.2196/55731