Coronary Artery DiseaseNCT01648673
Pilot Evaluation of the JHI Platform
An observational study of Coronary Artery Disease, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology services.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Cardiac Rehabilitation
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient referral, recruitment and retention rates and overall patient satisfaction.
Measured: Beginning, middle, and end of participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven J. Keteyian, Henry Ford Health System
- Investigators
- Steven J Keteyian, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648673
- Sponsor's protocol ID
- HFHS-JHI Platform
- Status last verified
- Feb 2020
- First submitted
- 20 Jul 2012
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).
- ClinicalTrials.gov ID
- NCT01648673
- Acronym / sponsor ID
- HFHS-JHI Platform
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology services.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient referral, recruitment and retention rates and overall patient satisfaction.
Time frame: Beginning, middle, and end of participation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Keteyian, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient referral, recruitment and retention rates and overall patient satisfaction. (time frame: Beginning, middle, and end of participation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.