Myocardial InfarctionENROLLNCT01596036
Readiness for Behavior Change After a Heart Attack
A study testing Early appointment (within 10 days) and Routine referral (at 5 weeks) in people with Myocardial Infarction and Stable Angina, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Stable Angina, Coronary Artery Disease
- What is being tested?
- Early appointment (within 10 days) and Routine referral (at 5 weeks)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2012
- Phase
- Interventional
- 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
Who may be able to join
- Stable Angina
- Myocardial infarction
- Percutaneous coronary intervention
- willingness to participate and consent for medical record review
- willingness to complete survey's
Who cannot join
- Recent illicit drug use
- Unstable psychiatric condition
- Moderate or severe dementia
- Inability to follow-up
- Leaving system with plans to enroll in cardiac rehabilitation out-of-system
- Inability to exercise (amputee, severe claudication)
Show all 10Show fewer
- Unstable medical condition that would prevent regular exercise training
- Uncorrected severe aortic stenosis or severe mitral stenosis
- Referring physician feels that exercise is contra-indicated due to safety or other patient specific factors
- CABG, LVAD, or Heart Transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.
Read the detailed description
Cardiac Rehabilitation is central to full recovery after a myocardial infarction or a cardiac stenting procedure. Yet, this therapy is underutilized across the nation. Henry Ford currently enrolls about 42% of eligible patients. In addition, it currently takes, on average, 42 +/-26 days from hospital discharge to enrollment in rehabilitation. During this delay, there is strong tendency to return to prior habits (sedentary lifestyle, smoking, poor nutrition, etc.) that led to the myocardial infarction in the first place. This delay is both 1) unnecessary and 2) probably harmful to the patients' readiness to make changes.
The investigators seek to perform a randomized controlled trial of early (7-10 days) vs standard referral (5-6 weeks) to cardiac rehabilitation. In addition, the investigators will examine the patients' readiness to change through the first 3 months of the post-hospitalization period and correlate that to their behavior and enrollment in cardiac rehabilitation. Assessment of readiness to change will be accomplished by serial survey's, which will be administered at discharge, 2 weeks, 5 weeks, and 13 weeks after discharge.
Patients will consent to take the survey and be observed in a clinical study. However, in order to avoid the Hawthorne Effect, patients they will not initially be aware of the primary hypothesis, as the investigators strongly believe this will affect the main behavior they are trying to measure. Full patient disclosure will occur at the end of the trial.
- Being tested
- Early appointment (within 10 days), Routine referral (at 5 weeks)
- Keywords
- cardiac rehabilitation, referral, enrollment, timing
- Medical subject headings
- Myocardial Infarction, Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early appointment (within 10 days)Behavioural
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Routine referral (at 5 weeks)Other
Standard Referral to Cardiac Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Early Appointment | Experimental | Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge Receives: Behavioral: Early appointment (within 10 days) |
| Standard Referral | Placebo comparator | Patients will receive an appointment to cardiac rehabilitation at 5 weeks from the date of their anticipated hospital discharge. A routine referral to cardiac rehabilitation will also occur in parallel. Consequently, it is possible that some patients will attend cardiac rehabilitation earlier than their assigned 5 week appointment. Receives: Other: Routine referral (at 5 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at the free orientation session for Cardiac Rehabilitation
Measured: within 5 weeks of randomized apointment date
Secondary outcomes (5)
Completion of at least one exercise session in Cardiac Rehabilitation
Measured: within 1 month of orientation date
Total number of cardiac rehabilitation exercise sessions attended
Measured: within 6 months of actual orientation date
Completion of the cardiac rehabilitation program
Completion is defined at attending the number of sessions agreed to at the onset of cardiac rehabilitation (e.g. agreeing to 3 session and attending 3) or attending 12 or more sessions.
Measured: within 6 months
Change in exercise capacity from the beginning to end of cardiac rehabilitation
exercise capacity will be calculated from treadmill workloads using standardized formulas published in the 8th edition of ACSM's Guidelines for exercise testing and prescription
Measured: within 6 months
Readiness to make positive behavior changes
Based on a 10 question survey, each patient will have a summary score to collapse across these questions. This summary score will be compared at 0, 5, and 13 weeks.
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quinn R Pack, Henry Ford Health System
- Investigators
- Quinn R Pack, MD, Principal investigator, Henry Ford HospitalSteven J Keteyian, PhD, Study director, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596036
- Sponsor's protocol ID
- HFHS 6649
- Acronym
- ENROLL
- Status last verified
- Nov 2012
- First submitted
- 9 May 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
PubMed 22082676Russell KL, Holloway TM, Brum M, Caruso V, Chessex C, Grace SL. Cardiac rehabilitation wait times: effect on enrollment. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):373-7. doi: 10.1097/HCR.0b013e318228a32f.
PubMed 21826016Pack QR, Mansour M, Barboza JS, Hibner BA, Mahan MG, Ehrman JK, Vanzant MA, Schairer JR, Keteyian SJ. An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation. 2013 Jan 22;127(3):349-55. doi: 10.1161/CIRCULATIONAHA.112.121996. Epub 2012 Dec 18.
PubMed 23250992
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
- ClinicalTrials.gov ID
- NCT01596036
- Acronym / sponsor ID
- ENROLL / HFHS 6649
- Keywords
- cardiac rehabilitation, referral, enrollment, timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 May 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 purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.
Detailed description
Cardiac Rehabilitation is central to full recovery after a myocardial infarction or a cardiac stenting procedure. Yet, this therapy is underutilized across the nation. Henry Ford currently enrolls about 42% of eligible patients. In addition, it currently takes, on average, 42 +/-26 days from hospital discharge to enrollment in rehabilitation. During this delay, there is strong tendency to return to prior habits (sedentary lifestyle, smoking, poor nutrition, etc.) that led to the myocardial infarction in the first place. This delay is both 1) unnecessary and 2) probably harmful to the patients' readiness to make changes.
The investigators seek to perform a randomized controlled trial of early (7-10 days) vs standard referral (5-6 weeks) to cardiac rehabilitation. In addition, the investigators will examine the patients' readiness to change through the first 3 months of the post-hospitalization period and correlate that to their behavior and enrollment in cardiac rehabilitation. Assessment of readiness to change will be accomplished by serial survey's, which will be administered at discharge, 2 weeks, 5 weeks, and 13 weeks after discharge.
Patients will consent to take the survey and be observed in a clinical study. However, in order to avoid the Hawthorne Effect, patients they will not initially be aware of the primary hypothesis, as the investigators strongly believe this will affect the main behavior they are trying to measure. Full patient disclosure will occur at the end of the trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Appointment | Experimental | Behavioral: Early appointment (within 10 days)Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge |
| Standard Referral | Placebo comparator | Other: Routine referral (at 5 weeks)Patients will receive an appointment to cardiac rehabilitation at 5 weeks from the date of their anticipated hospital discharge. A routine referral to cardiac rehabilitation will also occur in parallel. Consequently, it is possible that some patients will attend cardiac rehabilitation earlier than their assigned 5 week appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable Angina
- Myocardial infarction
- Percutaneous coronary intervention
- willingness to participate and consent for medical record review
- willingness to complete survey's
Key exclusion criteria (10 listed)
- Recent illicit drug use
- Unstable psychiatric condition
- Moderate or severe dementia
- Inability to follow-up
- Leaving system with plans to enroll in cardiac rehabilitation out-of-system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early appointment (within 10 days)Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge. | Behavioural | Early Appointment |
| Routine referral (at 5 weeks)Standard Referral to Cardiac Rehabilitation | Other | Standard Referral |
Primary outcome
Attendance at the free orientation session for Cardiac Rehabilitation
Time frame: within 5 weeks of randomized apointment date
5 secondary outcomes
Completion of at least one exercise session in Cardiac Rehabilitation
Time frame: within 1 month of orientation date
Total number of cardiac rehabilitation exercise sessions attended
Time frame: within 6 months of actual orientation date
Completion of the cardiac rehabilitation program
Time frame: within 6 months
Change in exercise capacity from the beginning to end of cardiac rehabilitation
Time frame: within 6 months
Readiness to make positive behavior changes
Time frame: within 3 months
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 14 Nov 2012.
- Background: PubMed 22082676Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
- Background: PubMed 21826016Russell KL, Holloway TM, Brum M, Caruso V, Chessex C, Grace SL. Cardiac rehabilitation wait times: effect on enrollment. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):373-7. doi: 10.1097/HCR.0b013e318228a32f.
- Derived from this study: PubMed 23250992Pack QR, Mansour M, Barboza JS, Hibner BA, Mahan MG, Ehrman JK, Vanzant MA, Schairer JR, Keteyian SJ. An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation. 2013 Jan 22;127(3):349-55. doi: 10.1161/CIRCULATIONAHA.112.121996. Epub 2012 Dec 18.
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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.
Quinn R Pack, MD principal investigator
Henry Ford Hospital
Steven J Keteyian, PhD study director
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early appointment (within 10 days) and Routine referral (at 5 weeks) in people with Myocardial Infarction and Stable Angina, 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 5 inclusion and 10 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 14 Nov 2012. 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. Some participants in this study may receive a placebo. 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?
Attendance at the free orientation session for Cardiac Rehabilitation (time frame: within 5 weeks of randomized apointment date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596036, which also lists 3 linked publications.
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 14 Nov 2012; AzTrials last refreshed its copy on 27 Oct 2026.