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Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

Sponsor
St. Louis University (Other)
Overall Status
Completed
CT.gov ID
NCT03491982
Collaborator
(none)
25
Enrollment
1
Location
18.4
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Remote Cardiac Rehab
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation
Actual Study Start Date :
Mar 19, 2018
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients completing remote rehab program compared to case controls [Immediately after cardiac rehab completion or stoppage]

Secondary Outcome Measures

  1. Six minute walk test compared to case controls [Immediately after cardiac rehab completion or stoppage]

  2. depression score vs case controls [Immediately after cardiac rehab completion or stoppage]

  3. Average number of minutes in exercise rehab compared to case controls [Immediately after cardiac rehab completion or stoppage]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Louis University - SLUCare Saint Louis Missouri United States 63117

Sponsors and Collaborators

  • St. Louis University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lisa Alderson MD, F.A.C.C., Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier:
NCT03491982
Other Study ID Numbers:
  • 28544
First Posted:
Apr 9, 2018
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lisa Alderson MD, F.A.C.C., Assistant Professor, St. Louis University
Cardiac Rehabilitation

Study Results

No Results Posted as of Nov 1, 2019