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OpenTrials
Completed

NCT Number: NCT04286113

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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

Primary outcomes

  1. Change in clinical trials participation Change in User Adherence

    Time frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit

    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.

  2. Change in glucose level Change in blood pressure

    Time frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit

    The amount of sugar levels will be determined the Harris-Benedict Calculator, which consists of height, weight, weight age and activity levels

  3. Change in body mass index Change in blood pressure

    Time frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit

    Change in body mass index will be determined by the self reported information the vb=vodt

  4. Change in physical activity

    Time frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit

    FitBit tracking will measure increase in physical activity adherence.

  5. Change in physical activity by self-report

    Time frame: Baseline Visit, 4 week follow up visit, 6 month follow up visit

    Increase in physical activity will be measured by self-report diaries collected by study staff through health and wellness app platforms.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2020
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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