Myocardial Infarction Clinical Trial
— CMOfficial title:
The Effectiveness of Case-management Rehabilitation Intervention in Facilitating Return to Work and Maintenance of Employment After Myocardial Infarction: Results of a Randomized Controlled Trial
NCT number | NCT04934735 |
Other study ID # | 2006038 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2007 |
Est. completion date | August 31, 2011 |
Verified date | June 2021 |
Source | Assuta Hospital Systems |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Abstract Purpose: To study the long-term effectiveness of case-management rehabilitation intervention among patients after myocardial infarction (MI) compared with the current standard of care. Methods: Participants were 151 patients who underwent uncomplicated MI and of which nearly all enrolled in a cardiac rehabilitation program. Patients were randomized into an intervention or control group and provided two years of follow-up data. The intervention, conducted within an occupational medicine clinic, started during hospitalization or immediately thereafter and continued for 2 years. It included: early referral to an occupational physician, charting an occupational intervention program, coordinating between the patient and relevant parties, psychosocial intervention, intensive follow-up sessions during the first 1.5 months, and more spaced interventions during the follow-up period. Outcome variables were: return to work within 6 months of hospitalization and maintenance of employment at one and two years of follow-up.
Status | Completed |
Enrollment | 151 |
Est. completion date | August 31, 2011 |
Est. primary completion date | June 30, 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 57 Years |
Eligibility | Inclusion Criteria: - Sex/Gender: Both males and females - Age limits: Minimum Age: 25 years old; Maximum age: 57 years old - Clinical diagnosis: Patients after acute myocardial infarction - Occupational status: Patients that have been working before the myocardial infarction - HMO membership: Members in Maccabi Healthcare Service (HMO in Israel) - Sampling Method: A consecutive participant sampling took place. Each patient who fulfilled the study terms was invited to participate in the study Exclusion Criteria: - Age over 57 years old or less than 25 years old - Clinical diagnosis: Patients who had not sustained acute myocardial infarction - Occupational status: Not working 6 months prior to the acute myocardial infarction - HMO membership: Non-members of Maccabi Healthcare Service (HMO in Israel). - Consent to participate: Patients who have not agreed to participate in the study |
Country | Name | City | State |
---|---|---|---|
Israel | ?Shlomo Moshe? | Rishon LeZion |
Lead Sponsor | Collaborator |
---|---|
Assuta Hospital Systems |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants' return-to-work rates within 6 months from hospital discharge | This outcome measures the percentage of participants in either study or control groups, who have returned to work within 6 months of hospital discharge. This time window represents the optimal return to work period for most cardiac patients and assesses the effectiveness of the intervention in supporting the return to work process. | Up to 6 months from hospital discharge | |
Primary | Percentage of participants that maintained their employment at 12, 18, and 24 months of follow-up | This outcome measures the percentage of participants in either study or control groups that have maintained their employment over time after having returned to work.
Since some participants may not be capable of maintaining their employment status despite having returned to work, this outcome represents the effectiveness and quality of the return to work process and assesses the contribution of the case manager in supporting the participants' overall return to work. |
Up to 24 months from hospital discharge | |
Secondary | Occupational status of employed patients (full-time vs. part-time) | This outcome measures the degree of employment (full vs. part-time) of participants that have returned to work after their myocardial event.
Some participants are able to return to full-time work, others need their work hours accommodated - this measure provides more information on the employment status amongst those that have managed to return to work and the effectiveness of the case manager in supporting the return to full-time work. |
Up to 24 months from hospital discharge | |
Secondary | Occupational status of employed patients (Same vs. different job) | This outcome measures whether participants that return to work, will do so to their previous jobs/occupation or whether to a different job/occupation.
Some participants are able to maintain the same job/occupation, others require accommodations and/or restrictions - this measure provides more information on the employment status amongst those that have managed to return to work and the effect the case manager will have in supporting the return to the same job/occupation. |
Up to 24 months from hospital discharge |
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