Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491982
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Alderson MD, F.A.C.C., St. Louis University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Referred by Cardiologist for Phase 2 Cardiac Rehabilitation Device: Remote Cardiac Rehab Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 19, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: Remote Cardiac Rehab
    Remote Cardiac Rehab

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of patients completing remote rehab program compared to case controls [ Time Frame: Immediately after cardiac rehab completion or stoppage ]

Secondary Outcome Measures :
  1. Six minute walk test compared to case controls [ Time Frame: Immediately after cardiac rehab completion or stoppage ]
  2. depression score vs case controls [ Time Frame: Immediately after cardiac rehab completion or stoppage ]
  3. Average number of minutes in exercise rehab compared to case controls [ Time Frame: Immediately after cardiac rehab completion or stoppage ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491982


Locations
Layout table for location information
United States, Missouri
Saint Louis University - SLUCare
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
Layout table for investigator information
Principal Investigator: Lisa Alderson, MD St. Louis University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: April 9, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no current plan

Layout table for additional information
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., St. Louis University:
Cardiac Rehabilitation