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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04286113
Recruitment Status : Not yet recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: control group Behavioral: Lifestyle management Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREDHICT: Precision Recruitment and Engagement of Diabetics and Hypertensives in Clinical Studies
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : April 2021

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286113


Contacts
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Contact: Azizi Seixas 646-501-3430 azizi.seixas@nyulangone.org
Contact: Shannique Richards 646-501-3449 shannique.richards@nyulangone.org

Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Azizi Seixas NYU Langone
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04286113    
Other Study ID Numbers: 17-01791-substudy
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases