Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

Referred by Cardiologist for Phase 2 Cardiac Rehabilitation Clinical Trial

Official title:

Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491982
• Other study ID #: 28544
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Referred by Cardiologist for Phase 2 Cardiac Rehabilitation

Intervention

Device:
• Remote Cardiac Rehab
Remote Cardiac Rehab

Locations

Country	Name	City	State
United States	Saint Louis University - SLUCare	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients completing remote rehab program compared to case controls		Immediately after cardiac rehab completion or stoppage
Secondary	Six minute walk test compared to case controls		Immediately after cardiac rehab completion or stoppage
Secondary	depression score vs case controls		Immediately after cardiac rehab completion or stoppage
Secondary	Average number of minutes in exercise rehab compared to case controls		Immediately after cardiac rehab completion or stoppage