Pilot Evaluation of the JHI Platform
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Henry Ford Health System.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Steven J. Keteyian, Henry Ford Health System
First received: July 20, 2012
Last updated: March 18, 2013
Last verified: March 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).
Primary Outcome Measures:
- Patient referral, recruitment and retention rates and overall patient satisfaction. [ Time Frame: Beginning, middle, and end of participation. ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648673
|Henry Ford Hospital
|Detroit, Michigan, United States, 48202 |
|Contact: Matthew A Saval, MS 313-972-4018 firstname.lastname@example.org |
|Principal Investigator: Steven J Keteyian, PhD |
Henry Ford Health System
||Steven J Keteyian, PhD
||Henry Ford Health System
No publications provided
||Steven J. Keteyian, Program Director, Henry Ford Health System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 20, 2012
||March 18, 2013
||United States: Institutional Review Board
United States: Food and Drug Administration
Keywords provided by Henry Ford Health System:
Coronary Artery Disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Coronary Artery Disease
Arterial Occlusive Diseases