Coronary Artery Disease Clinical Trial
Official title:
Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).
| NCT number | NCT01648673 |
| Other study ID # | HFHS-JHI Platform |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2012 |
| Est. completion date | April 2017 |
| Verified date | February 2020 |
| Source | Henry Ford Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | April 2017 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Henry Ford Hospital | Detroit | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Henry Ford Health System |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient referral, recruitment and retention rates and overall patient satisfaction. | Beginning, middle, and end of participation. |
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