Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Referred by Cardiologist for Phase 2 Cardiac Rehabilitation
• Intervention / Treatment: Device: Remote Cardiac Rehab

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Saint Louis University - SLUCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients completing remote rehab program compared to case controls	Immediately after cardiac rehab completion or stoppage

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Lisa Alderson, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation
• Other Study ID Numbers: 28544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no current plan

Drug and device information, study documents

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