Clinical trial NCT04286113: PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies
Official title: PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* NYU and/or Bellevue patient
* Diagnosed with HTN and pre-diabetes/diabetes
* Must be English speakers
* Ownership of a smart phone and are willing to use it to download app built in TrialX which will be free for participants
* Must be ambulatory

Exclusion Criteria:

* are unable or unwilling to provide informed consent;
* are unable to participate meaningfully in an intervention that involves self-- monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
* are institutionalized (e.g., in a nursing home or personal care facility, or those who - are incarcerated and have limited control over self-management)
* have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)

Primary outcomes:
measure: Change in clinical trials participation Change in User Adherence
timeFrame: Baseline Visit, 4 week follow up visit, 6 month follow up visit
measure: Change in glucose level Change in blood pressure
timeFrame: Baseline Visit, 4 week follow up visit, 6 month follow up visit
measure: Change in body mass index Change in blood pressure
timeFrame: Baseline Visit, 4 week follow up visit, 6 month follow up visit
measure: Change in physical activity
timeFrame: Baseline Visit, 4 week follow up visit, 6 month follow up visit
measure: Change in physical activity by self-report
timeFrame: Baseline Visit, 4 week follow up visit, 6 month follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone
name: Azizi Seixas
role: PRINCIPAL_INVESTIGATOR
References: