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

NCT ID: NCT04286113

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-10-27

Brief Summary

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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

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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

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Participants will receive non-personalized information (one-size-fits-all) diet, sleep and physical activity recommendations via messaging delivered by app.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Lifestyle management

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azizi Seixas

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

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NYU Langone

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-01791-substudy

Identifier Type: -

Identifier Source: org_study_id