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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: control group; Behavioral: Lifestyle management

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Participants will receive non-personalized information (one-size-fits-all) diet, sleep and physical activity recommendations via messaging delivered by app.	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.
Experimental: Intervention Group; Participants will receive personalized messages about achieving healthy diet, physical activity and sleep as well as summary of their performance for the week and month. They will also receive personalized content about research volunteerism and altruistic activities.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Azizi Seixas, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 17-01791-substudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No