Wearables and Cardiac Rehabilitation

NCT06065319 | Active Not Recruiting

• 1 other identifier: R21EB028486
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Rehabilitation

Keywords

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Improvement in cardiac function

  Improvement in the 6 minute walk test performance from pre assessment to post assessment

  12 weeks, 36 session cardiac rehabilitation

Study Arms (1)

All Comers to Cardiac Rehabilitation

Any participant that is enrolled in cardiac rehabilitation is eligible for this study.

Device: Wearable Sensors

Interventions

Wearable Sensors DEVICE

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.

All Comers to Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead
• Ascension Health: collaborator

Study Sites (2)

Ascension Health

Austin, Texas, 78705, United States

Location

Texas A&M University

College Station, Texas, 77843, United States

Location

Study Officials

• Thomas Kurian

  Ascension Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: October 3, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: At the end of the study and for at least 3 years
• Access Criteria: Reasonable request and data use agreement with investigators

Locations

US (2)