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

NCT04286113 | Completed DMC

• 1 other identifier: 17-01791-substudy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Behavioral: control group

Intervention Group

EXPERIMENTAL

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

Interventions

control group 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.

Control group

Lifestyle management 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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Azizi Seixas

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: February 26, 2020
• Study Start: October 20, 2020
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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).
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)