RECRUITING

Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.

Official Title

Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT

Quick Facts

Study Start:2024-10-08
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06753045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke/Transient Ischemic Attack (TIA), or diabetes mellitus).
  2. * Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study).
  1. * Participants who cannot read, speak, and/or understand English.
  2. * Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form.
  3. * Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
  4. * Participants who are pregnant.
  5. * Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device.
  6. * Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).
  7. * Participants with a pacemaker.
  8. * Participants with allergies to watch and/or wristband materials.
  9. * Participants with known plans to permanently leave the state of Louisiana within the observational period.
  10. * Participants who have no known medical history with any of the enrolling institutions.
  11. * Patients without a compatible smartphone (iOS 13 \& Android 11 at minimum).

Contacts and Locations

Study Contact

Kunal Sameer, MD
CONTACT
504-988-3058
heartbeat@tulane.edu
Quintrele Jones, MPH
CONTACT
504-988-3063
qjones1@tulane.edu

Principal Investigator

Nassir Marrouche, MD
PRINCIPAL_INVESTIGATOR
Tulane University

Study Locations (Sites)

East Jefferson General Hospital
New Orleans, Louisiana, 70006
United States
Tulane University Medical Group Clinics
New Orleans, Louisiana, 70112
United States
University Medical Center
New Orleans, Louisiana, 70112
United States

Collaborators and Investigators

Sponsor: Tulane University

  • Nassir Marrouche, MD, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-10-08
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Heart failure
  • Coronary artery disease
  • Stroke/TIA
  • Diabetes mellitus
  • Chronic kidney disease
  • Cardiac arrhythmias
  • Smart watch
  • Atrial fibrillation
  • A-fib
  • Artificial intelligence
  • Machine learning

Additional Relevant MeSH Terms

  • Heart Diseases