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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286113
• Other study ID #: 17-01791-substudy
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical trials participation Change in User Adherence	Will show that one-size-fits-all versus personalization leads to greater adherence. Adherence will be based on whether the subject met the daily and weekly behavior recommendations.	Baseline Visit, 4 week follow up visit, 6 month follow up visit
Primary	Change in glucose level Change in blood pressure	The amount of sugar levels will be determined the Harris-Benedict Calculator, which consists of height, weight, weight age and activity levels	Baseline Visit, 4 week follow up visit, 6 month follow up visit
Primary	Change in body mass index Change in blood pressure	Change in body mass index will be determined by the self reported information the vb=vodt	Baseline Visit, 4 week follow up visit, 6 month follow up visit
Primary	Change in physical activity	FitBit tracking will measure increase in physical activity adherence.	Baseline Visit, 4 week follow up visit, 6 month follow up visit
Primary	Change in physical activity by self-report	Increase in physical activity will be measured by self-report diaries collected by study staff through health and wellness app platforms.	Baseline Visit, 4 week follow up visit, 6 month follow up visit