NCT04286113

PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

For the sub-study, this digital navigation tool will both inform/educate, engage, support, and navigate participants and providers through the process of clinical trial participation via personalization (data profiling, adaptive and customized messaging, and tailored digital navigation) in a sample of 100 participants with diabetes and hypertension.

Detailed description

To identify provider- and system-level facilitators (solutions) of clinical trial participation that can be in corporated in the digital navigation tool. We will pay special emphasis on the behavior research volunteerism and altruism and individuals who are at risk for cardio metabolic conditions. To develop solutions that will address patient-, provider and system-level barriers preventing clinical trial participation Objective 2: To test the adherence, feasibility, and efficacy of a research volunteerism and altruism component of a health and wellness web app. that provides personalized newsfeeds and curriculum about research and health-related volunteer and altruistic activities versus traditional patient navigation procedures and resources in clinical trial awareness.'awareness/knowledge, attitudes, willingness to participate in clinical trial, self-efficacy, and share knowledge about clinical trial opportunities to social network. To determine which elements of the digital tool and mobil app are associated with increased awareness/knowledge, intent to participate, and contagion

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	control group	will receive standard medical care where research assistant will give pamphlets, with one size fits all recommendations for diet/nutrition, physical activity and sleep, to 10 subjects with comorbid HTN and T2D.
BEHAVIORAL	Lifestyle management	Will use passive ubiquitous sensing through FitBit to 1)learn behavioral profiles of subjects who have pre-HTN/HTN and/or pre-diabetes /Diabetes 2) provide personalized recommendations through mobile based messaging app that will increase the likelihood of engaging in health diet/nutrition, physical activity and sleep practices

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2020-02-26
• Last updated: 2021-12-10

Locations

1 site across 1 country: United States