Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

Not Applicable

Completed

• Conditions: Referred by Cardiologist for Phase 2 Cardiac Rehabilitation

• Registration Number: NCT03491982
• Lead Sponsor: St. Louis University

Brief Summary

This study evaluates the compliance of patients in a Phase 2 (outpatient clinic based) cardiac rehabilitation program, who are offered the opportunity to perform the rehab remotely (e.g. at home, not at the clinic), using a remote monitor and smart-phone application.

Detailed Description

In spite of the fact that cardiac rehabilitation has been shown to be beneficial to patients who have had a cardiac event, such as a heart attack, only 5% of eligible patients complete this program. Some of the reasons cited include limited facility access, travel time and cost.

We are testing the hypothesis that cardiac rehab compliance will be greater if patients are offered the opportunity, and associated technology, to perform cardiac rehab anywhere.

Study Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-09
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• referred to SLU cardiac rehab facility

Exclusion Criteria

• does not own app compatible smart phone
• dementia
• syncope
• valvular disease
• life expectancy < 1 year
• non-English speaking
• unstable angina
• decompensated congestive heart failure
• ventricular arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of patients completing remote rehab program compared to case controls	Immediately after cardiac rehab completion or stoppage

Secondary Outcome Measures

Name	Time	Method
Six minute walk test compared to case controls	Immediately after cardiac rehab completion or stoppage
depression score vs case controls	Immediately after cardiac rehab completion or stoppage
Average number of minutes in exercise rehab compared to case controls	Immediately after cardiac rehab completion or stoppage

Trial Locations

Locations (1)

Saint Louis University - SLUCare; 🇺🇸 Saint Louis, Missouri, United States