Wearables and Cardiac Rehabilitation

Estimating Recovery in Cardiac Rehabilitation Using Mobile Health Technology and Personalized Machine Learning

The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring recovering of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Device: Wearable Sensors

Detailed Description

The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring the recovery of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

This work will use data from cardiac rehabilitation, captured from smartwatches, and data from rest/sleep, captured from smartwatches and smartrings, to see if there are trends in recovery that can be modeled. Recovery is measured as an improvement in 6 minute walk test performance over the course of cardiac rehabilitation.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Chloe Cowan; Phone Number: 51232443434; Email: chloe.cowan@ascension.org
• Study Contact Backup: Name: Bobak Mortazavi; Phone Number: 9794582642; Email: bobakm@tamu.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Ascension Health
      • Contact: Chloe Cowan; Phone Number: 512-324-3434; Email: chloe.cowan@ascension.org
      • Principal Investigator: Thomas Kurian
    • College Station, Texas, United States, 77843
      • Texas A&M University
      • Contact: Bobak J Mortazavi, PhD; Phone Number: 979-458-2642; Email: bobakm@tamu.edu
      • Principal Investigator: Bobak J Mortazavi, PhD
      • Sub-Investigator: Roozbeh Jafari, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All-comers to cardiac rehabilitation who are capable of using smartphones for remote data collection

Description

Inclusion Criteria:

• Enrollment in Cardiac Rehabilitation - eligible all-comers to Cardiac Rehabilitation
• Age 18 or older
• Native English speaker

Exclusion Criteria:

• Inability to wear one or more SmartWatches or Smartring
• Inability to walk unassisted
• Inability to participate in cardiac rehabilitation
• Inability to use a smartphone to aid in upload of remote data
• Lack of smartphone to use in the study
• There is a change in participant health such that the participant meets any of the exclusion criteria for this study during the course of the cardiac rehab sessions

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Comers to Cardiac Rehabilitation; Any participant that is enrolled in cardiac rehabilitation is eligible for this study.	Device: Wearable Sensors; Participants will wear smartwatches and smartrings and this data will be used to design algorithms which seek to find associations between device data and recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in cardiac function	Improvement in the 6 minute walk test performance from pre assessment to post assessment	12 weeks, 36 session cardiac rehabilitation

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Ascension Health
• Investigators: Principal Investigator: Thomas Kurian, Ascension Health

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation
• Other Study ID Numbers: R21EB028486 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified wearable data and 6minute walk data will be made available, upon reasonable request, for other researchers
• IPD Sharing Time Frame: At the end of the study and for at least 3 years
• IPD Sharing Access Criteria: Reasonable request and data use agreement with investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No