Case ManagerCMNCT04934735
Case-management Rehabilitation Intervention in Facilitating Return to Work After Myocardial Infarction
A study testing Rehabilitation program group in people with Case Manager and Myocardial Infarction, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 57 years
- Conditions the study is for
- Case Manager, Myocardial Infarction, Sick Leave
- What is being tested?
- Rehabilitation program group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2007to 31 Aug 2011
- 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 Up to 57 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
The program was conducted by a clinical social worker within the OM clinic and included several components:
- Intake by a CM covering information regarding the rehabilitating program, assessing the patients' perception of their illness and the impact of the event on their life and family. Also included were: familiarization with the patient's occupational background, assessment of motivation, expectations, perceived efficacy and difficulties concerning RTW, and the identification of areas of intervention. Referral to further evaluation and treatment by a psychologist/psychiatrist was up to the CM's discretion.
- Referral to an OP was within one week of the intake.
- Charting an occupational rehabilitation program and timing the RTW date, not later than 35 days from hospital discharge. Before their RTW date, patients were invited for an additional meeting with the CM to facilitate their readiness to RTW and make any necessary arrangements.
- Coordinating between the patients and their family, treating physicians, the employer, community services, and meeting with the patient's family - all on a needful basis.
- Provision of a guidance booklet for employers on the RTW of cardiac patients. Patients could read it by themselves and/or hand it to their employer.
- The psychosocial intervention was tailored to the patient's emotional state, occupational needs, and specific requests. When needed, short-term (up to 4 sessions) psychotherapeutic treatment was provided to help alleviate anxiety and other debilitating concerns, illness misconceptions, family issues, and occupational wavering.
- Intensive follow-up sessions aimed to ensure that the rehabilitation program was carried out as planned, were conducted 2-, 4-, and 6-weeks after the beginning of the psychosocial intervention.
Intervention during follow-up
- Patients who had RTW within three months after discharge from the hospital, received follow-up calls as follows: two weeks from the start of the CM intervention, every two months during the first six months, and once every six months thereafter (as outlined above). If needed, one or more of the above interventions were applied.
- Patients who had not RTW within six months after discharge, due to psychosocial or employer-related issues received up to 12 intensive intervention sessions, in which the relevant parties were involved. Upon successful RTW, the six months follow-up calls were resumed.
- Patients who had not RTW after six months for the above reasons, and were assessed as having rehabilitation potential, were referred to the National Social Security rehabilitation services and were followed up monthly for one year. The CM intervention was ended for patients without rehabilitation potential. For both groups, follow-up calls continued for six months.
The study received ethical approval from the institutional review board, serial number 2006038.
Statistical analysis Results are presented as mean + standard deviation (SD) for continuous variables and as frequencies for categorical variables. Data were analyzed using the SPSS statistical package (Version 26, SPSS Inc., Chicago, IL). Student's t-test was used to test for a difference between the means of two groups on a continuous dependent variable. Chi-square test of homogeneity was used to test for a difference between two proportions. For small groups, it was replaced by Fisher's exact test.
A multiple logistic regression model was used to investigate the relationship between employment status (employed/unemployed) at one year and two years of follow-up and CM program participation. Adjustments were made for factors that were found in previous studies to be associated with vocational re-integration and that could have confounded the findings of this study. A list of the possible confounders is presented in Table 4. Significance was determined by p<0.05.
- Conditions
- Case Manager, Myocardial Infarction, Sick Leave, Return to Work
- Being tested
- Rehabilitation program group
- Keywords
- Rehabilitation, return to work, maintenance of employment
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation program groupProcedure or surgery
Also called complex case-management rehabilitation program
The case-management rehabilitation program was conducted by a clinical social worker within the occupational medicine clinic and included several components:
- Intake by a case manager
- Referral to an occupational physician was within one week of the intake.
- Charting an occupational rehabilitation program and timing the RTW date
- Coordinating between the patients and their family, treating physicians, the employer, community services, and meeting with the patient's family - all on a needful basis.
- Provision of a guidance booklet for employers on the RTW of cardiac patients.
- The psychosocial intervention was tailored to the patient's emotional state, occupational needs, and specific requests.
- Intensive follow-up sessions aimed to ensure that the rehabilitation program was carried out as planned.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group: received a complex case-management rehabilitation program | Active comparator | The intervention group was followed at 6, 12, 18, 24 months after entering the study. The follow-up was conducted by the case manager for patients in the intervention group, and by a research assistant for patients in the control group. Medical data were retrieved from the computerized medical records in the relevant hospitals. Receives: Procedure: Rehabilitation program group |
| The control: group received the standard care | No intervention | The control group received regular care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months from hospital discharge
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.
Measured: Up to 24 months from hospital discharge
Secondary outcomes (2)
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.
Measured: Up to 24 months from hospital discharge
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.
Measured: Up to 24 months from hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jun 2007
- Primary completion30 Jun 2008
- Study completion31 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Case ManagerStudies 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
- Model description
- This prospective randomized controlled trial was conducted among patients who underwent an uncomplicated acute MI. Two weeks after hospitalization patients were referred to an examination by a cardiologist (to obtain a standardized clinical examination for all participants). Following this examination, the patients were assigned to an intervention group and a control group using simple randomization based on a computer-generated random sequence of numbers. The main outcomes are the rate of return to work in each phase of the study (meaning after 6,12,18, and 24 months)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shlomo Moshe, Assuta Hospital Systems
- Investigators
- Melamed Shmuel, Ass. Prof., Study chair, Tal Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934735
- Sponsor's protocol ID
- 2006038
- Acronym
- CM
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Owing to data privacy regulations, the raw data for this study cannot be shared.
Publications
Zack O, Melamed S, Silber H, Cinamon T, Levy D, Moshe S. 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. Clin Rehabil. 2022 Jun;36(6):753-766. doi: 10.1177/02692155221076826. Epub 2022 Feb 22.
PubMed 35191331
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04934735
- Acronym / sponsor ID
- CM / 2006038
- Conditions
- Case Manager, Myocardial Infarction, Sick Leave, Return to Work
- Keywords
- Rehabilitation, return to work, maintenance of employment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 30 Jun 2008 (actual)
- Study completion
- 31 Aug 2011 (actual)
- First posted
- 22 Jun 2021 (actual)
- 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.
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.
Detailed description
The program was conducted by a clinical social worker within the OM clinic and included several components:
- Intake by a CM covering information regarding the rehabilitating program, assessing the patients' perception of their illness and the impact of the event on their life and family. Also included were: familiarization with the patient's occupational background, assessment of motivation, expectations, perceived efficacy and difficulties concerning RTW, and the identification of areas of intervention. Referral to further evaluation and treatment by a psychologist/psychiatrist was up to the CM's discretion.
- Referral to an OP was within one week of the intake.
- Charting an occupational rehabilitation program and timing the RTW date, not later than 35 days from hospital discharge. Before their RTW date, patients were invited for an additional meeting with the CM to facilitate their readiness to RTW and make any necessary arrangements.
- Coordinating between the patients and their family, treating physicians, the employer, community services, and meeting with the patient's family - all on a needful basis.
- Provision of a guidance booklet for employers on the RTW of cardiac patients. Patients could read it by themselves and/or hand it to their employer.
- The psychosocial intervention was tailored to the patient's emotional state, occupational needs, and specific requests. When needed, short-term (up to 4 sessions) psychotherapeutic treatment was provided to help alleviate anxiety and other debilitating concerns, illness misconceptions, family issues, and occupational wavering.
- Intensive follow-up sessions aimed to ensure that the rehabilitation program was carried out as planned, were conducted 2-, 4-, and 6-weeks after the beginning of the psychosocial intervention.
Intervention during follow-up
- Patients who had RTW within three months after discharge from the hospital, received follow-up calls as follows: two weeks from the start of the CM intervention, every two months during the first six months, and once every six months thereafter (as outlined above). If needed, one or more of the above interventions were applied.
- Patients who had not RTW within six months after discharge, due to psychosocial or employer-related issues received up to 12 intensive intervention sessions, in which the relevant parties were involved. Upon successful RTW, the six months follow-up calls were resumed.
- Patients who had not RTW after six months for the above reasons, and were assessed as having rehabilitation potential, were referred to the National Social Security rehabilitation services and were followed up monthly for one year. The CM intervention was ended for patients without rehabilitation potential. For both groups, follow-up calls continued for six months.
The study received ethical approval from the institutional review board, serial number 2006038.
Statistical analysis Results are presented as mean + standard deviation (SD) for continuous variables and as frequencies for categorical variables. Data were analyzed using the SPSS statistical package (Version 26, SPSS Inc., Chicago, IL). Student's t-test was used to test for a difference between the means of two groups on a continuous dependent variable. Chi-square test of homogeneity was used to test for a difference between two proportions. For small groups, it was replaced by Fisher's exact test.
A multiple logistic regression model was used to investigate the relationship between employment status (employed/unemployed) at one year and two years of follow-up and CM program participation. Adjustments were made for factors that were found in previous studies to be associated with vocational re-integration and that could have confounded the findings of this study. A list of the possible confounders is presented in Table 4. Significance was determined by p<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This prospective randomized controlled trial was conducted among patients who underwent an uncomplicated acute MI. Two weeks after hospitalization patients were referred to an examination by a cardiologist (to obtain a standardized clinical examination for all participants). Following this examination, the patients were assigned to an intervention group and a control group using simple randomization based on a computer-generated random sequence of numbers. The main outcomes are the rate of return to work in each phase of the study (meaning after 6,12,18, and 24 months)
| Arm | Type | Receives |
|---|---|---|
| The intervention group: received a complex case-management rehabilitation program | Active comparator | Procedure: Rehabilitation program groupThe intervention group was followed at 6, 12, 18, 24 months after entering the study. The follow-up was conducted by the case manager for patients in the intervention group, and by a research assistant for patients in the control group. Medical data were retrieved from the computerized medical records in the relevant hospitals. |
| The control: group received the standard care | No intervention | –The control group received regular care. |
Who may qualify
- Ages
- Up to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Rehabilitation program groupAlso: complex case-management rehabilitation programThe case-management rehabilitation program was conducted by a clinical social worker within the occupational medicine clinic and included several components: 1. Intake by a case manager 2. Referral to an occupational physician was within one week of the intake. 3. Charting an occupational rehabilitation program and timing the RTW date 4. Coordinating between the patients and their family, treating physicians, the employer, community services, and meeting with the patient's family - all on a needful basis. 5. Provision of a guidance booklet for employers on the RTW of cardiac patients. 6. The psychosocial intervention was tailored to the patient's emotional state, occupational needs, and specific requests. 7. Intensive follow-up sessions aimed to ensure that the rehabilitation program was carried out as planned. | Procedure or surgery | The intervention group: received a complex case-management rehabilitation program |
Primary outcome
Participants' return-to-work rates within 6 months from hospital discharge
Time frame: Up to 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.
Percentage of participants that maintained their employment at 12, 18, and 24 months of follow-up
Time frame: Up to 24 months from hospital discharge
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.
2 secondary outcomes
Occupational status of employed patients (full-time vs. part-time)
Time frame: Up to 24 months from hospital discharge
Occupational status of employed patients (Same vs. different job)
Time frame: Up to 24 months from hospital discharge
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 25 Jun 2021.
- Derived from this study: PubMed 35191331Zack O, Melamed S, Silber H, Cinamon T, Levy D, Moshe S. 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. Clin Rehabil. 2022 Jun;36(6):753-766. doi: 10.1177/02692155221076826. Epub 2022 Feb 22.
- Individual participant dataSharing planned: No. Owing to data privacy regulations, the raw data for this study cannot be shared.
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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.
Melamed Shmuel, Ass. Prof. study chair
Tal Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program group in people with Case Manager and Myocardial Infarction, run by Assuta Hospital Systems at 1 site in Israel.
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 6 inclusion and 5 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 25 Jun 2021. 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 Israel. 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?
Participants' return-to-work rates within 6 months from hospital discharge (time frame: Up to 6 months from hospital discharge). The study lists 2 primary outcomes in all. 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 NCT04934735, which also lists 1 linked publication.
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 25 Jun 2021.