Pilot Evaluation of the JHI Platform

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Henry Ford Health System
Sponsor:
Information provided by (Responsible Party):
Steven J. Keteyian, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01648673
First received: July 20, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

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: 120
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiology services.

Criteria

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.
  Contacts and Locations
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

Contacts
Contact: Matthew A Saval, MS 313-972-4018 msaval1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Matthew A Saval, MS    313-972-4018    msaval1@hfhs.org   
Principal Investigator: Steven J Keteyian, PhD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Steven J Keteyian, PhD Henry Ford Health System
  More Information

No publications provided

Responsible Party: Steven J. Keteyian, Program Director, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01648673     History of Changes
Other Study ID Numbers: HFHS-JHI Platform
Study First Received: July 20, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Henry Ford Health System:
Coronary Artery Disease
Cardiac Rehabilitation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014