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Pilot Evaluation of the JHI Platform

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ClinicalTrials.gov Identifier: NCT01648673
Recruitment Status : Unknown
Verified July 2015 by Steven J. Keteyian, Henry Ford Health System.
Recruitment status was:  Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Steven J. Keteyian, Henry Ford Health System

Brief Summary:
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 or disease
Coronary Artery Disease

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).
Study Start Date : August 2012
Primary Completion Date : February 2015
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Patient referral, recruitment and retention rates and overall patient satisfaction. [ Time Frame: Beginning, middle, and end of participation. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT01648673


Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Steven J Keteyian, PhD Henry Ford Health System

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
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by Steven J. Keteyian, 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