- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01648673
Pilot Evaluation of the JHI Platform
February 12, 2020 updated by: Steven J. Keteyian, Henry Ford Health System
Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).
The main purpose of this pilot study is to evaluate an impact of JHI CR Platform on patient referral, recruitment and retention rates and overall patient satisfaction in cardiovascular rehabilitation programs at the HFHS.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cardiology services.
Description
Inclusion Criteria:
- Men and women age 18 years old (inclusive) and older
- Recent hospitalization at HFHS Main Campus hospital with one of the following diagnosis
- Stable angina with medical management
- Myocardial infarction (MI)/Acute coronary syndrome
- Percutaneous Coronary Intervention (PCI)
- Coronary Artery Bypass Graft (CABG) surgery
- Heart valve surgical repair or replacement
- Patients must be attending outpatient CR program at the HFHS Detroit location.
- Willingness to participate in the study and follow study requirements
- Willingness to respond to several surveys at the baseline and periodically during the study
Exclusion Criteria:
- Active substance abuse per medical record
- Unstable psychiatric condition
- Inability to exercise
- Unstable medical condition that would prevent safe and regular exercise training
- Uncorrected Severe Aortic Stenosis or Severe Mitral Stenosis
- Inpatient referring physician feels that exercise in contra-indicated due to safety reasons or is ill advised due to other patient specific factors
- LVAD, Heart Transplant. Although these patients qualify for CR, HFHS is not recruiting them due to difficulty in coordinating with surgical patients and their providers. In addition, there may also be surgical issues (infection, wound dehiscence, bone healing etc) that may reasonably interfere with exercise.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient referral, recruitment and retention rates and overall patient satisfaction.
Time Frame: Beginning, middle, and end of participation.
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Beginning, middle, and end of participation.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
July 20, 2012
First Submitted That Met QC Criteria
July 23, 2012
First Posted (Estimate)
July 24, 2012
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 12, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFHS-JHI Platform
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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