Acute Myocardial Infarction: Rehabilitation PhaseNCT02402582
Effect of Family-Centered Empowerment Model
A study testing Family-centered empowerment model in people with Acute Myocardial Infarction: Rehabilitation Phase, run by Baqiyatallah Medical Sciences University.
Trial summary
The objective of this study was to evaluate the effectiveness of a FCEM-focused hybrid CR program for survivors of myocardial infarction (MI). The study sought to compare the long-term impact of FCEM-based intervention with a standard CR program in terms of mortality rates and different aspects of health related… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction: Rehabilitation Phase
- What is being tested?
- Family-centered empowerment model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to 1 Jan 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being within the age-range of 45 to 85 years old
- having the minimum literacy for reading and writing
- being hospitalized due to MI for the first time
- verification of MI by clinical symptoms
- enzyme-serum tests and cardiograph changes
- lack of participation in the any related educational course simultaneously with the execution of intervention
Show all 9Show fewer
- patients' willingness toward participating in the research
- having no psychological problems
- ability to fill out the questionnaire and participating in the empowerment program.
Who cannot join
- any offending items from mentioned criteria.
About this study
Official title: Family-Centered Empowerment Model With Four-stage Including Perceived Threat With Group Discussion Method, Self-efficacy With Problem Solving Method, Self-esteem With Educational Partnership, and Outcome and Process Evaluations
The objective of this study was to evaluate the effectiveness of a FCEM-focused hybrid CR program for survivors of myocardial infarction (MI). The study sought to compare the long-term impact of FCEM-based intervention with a standard CR program in terms of mortality rates and different aspects of health related quality of life (HRQoL), which includes soft outcomes such as levels of stress, anxiety, psychological distress, quality of life (QoL), and hard outcomes such as the percentage of ejection fraction (EF), independent functioning, and functional exercise capacity status.
Read the detailed description
The investigators conducted a triple-blind randomized controlled clinical trial study in patients admitted for MI to the CCU of an academic teaching hospital from June 2012 to January 2023. The study was approved by the institutional investigative review board at Tarbiat Modares University and Baqiyatallah University of Medical Sciences. Patients were block randomized to receive either standard home cardiac rehabilitation (CR) or CR using the Family-centered Empowerment Model (FCEM) strategy. Patients had not previously gone through CR programs. The difference between the two groups was not disclosed at any point. Patients consented knowing that they would receive cardiac rehabilitation, but without knowing the details. Patients and their designated family/friend were enrolled as a 'unit'. Patient empowerment was measured with FCEM questionnaires pre-intervention and post-intervention for a total of 9 assessments. Quality-of-life, perceived stress, state and trait anxiety, psychological distress, independent functioning, and functional exercise capacity status were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, the 20-item State and 20-item Trait Anxiety questionnaires, Kessler Psychological Distress Scale,Barthel Index (BI) activities of daily living index, six-minute walk test (6MWT), and free walking index (FWI), respectively. In addition, echocardiography was used to measure ejection fraction.
- Being tested
- Family-centered empowerment model, Control
- Keywords
- Family-Centered Empowerment Model, Quality of life, Perceived stress, Anxiety, Myocardial infarction, Clinical trial, Iran
- Medical subject headings
- Anxiety Disorders, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centered empowerment modelOther
Also called FCEM
FCEM and Control groups had similar inpatient care. Patients in the intervention group received care employing the FCEM in four stages. Stage 1: Awareness and cognition. During 3-5 group sessions they were evaluated for their insight into their perceived illness severity and perceived sensitivity, or the degree to which they felt threatened by their illness. Stage 2: Expectations. 3-5 sessions. Stage 3: Acceptance. Assessed using an educational participation method in group discussion. Stage 4: Formative summative evaluations. The formative evaluation encourages patients to internalize their locus of control by seeing his/her self-empowerment (increasing self-responsibility about their health). Summative evaluations were performed to evaluate the influence of the intervention on HRQoL dimensions, perceived stress and anxiety -- assessed at baseline and at 3 months post-intervention. Empowerment was measured at baseline and at 10 days post-intervention by deploying FCEM questionnaires.
ControlOther
FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Family-Centered Empowerment Model | Experimental | Have the same in-patient, pre-intervention, and post-intervention follow-up care as Control Group. However, rather than routine care and follow-up during the intervention period, they recieved than 4 stage intervention using the Family Centered Empowerment Model. Receives: Other: Family-centered empowerment model |
| Control | Active comparator | Same in-patient, pre-intervention, and post-intervention follow-up care as Experimental Group. However, rather than 4 stage intervention they receive routine care and follow-up. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
5-year, 7-year, and 10-year mortality rates of MI survivors who received a FCEM-focused hybrid CR program as intervention group compared with those who received a standard CR program as control group
Measured: 10-year
Secondary outcomes (4)
Patient Stress
14-item Perceived Stress Questionnaire (PSQ-14)
Measured: 48 months
Anxiety
Beck 20-Item state and 20-Item trait anxiety Questionnaires
Measured: 48 months
Level of quality of life
the 36-Item Short Form Health Survey (SF-36)
Measured: 48 months
psychological distress
Psychological Distress Scale (K10)
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction: Rehabilitation PhaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients had similar inpatient rehabilitation programs. Both groups exercised for 0-2h/day. Walking distance was measured using a Fitbit (Fitbit, San Francisco, USA). Routine care included education on smoking cessation and education on food selection. FCEM: Daily exercise occurred between 8-10 AM and was supervised by designated family members. Investigators randomly attended sessions in an unannounced fashion. Physical therapy consultation was available on investigator request. Exercise data were independently collected from the patient and their designated family member on a weekly basis (κ statistic=0.9). Control: Patients exercised daily, at any time. Sessions were supervised by family members. Investigators did not attend sessions. Exercise data were independently collected from the patient and their designated family member on a weekly basis (κ statistic=0.4).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Tarbiat Modarres University
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
- Investigators
- Amir vahedian-azimi, Resea fellow, Principal investigator, BMSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402582
- Sponsor's protocol ID
- BMSU
- Status last verified
- Jun 2023
- First submitted
- 20 Mar 2015
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vahedian-Azimi A, Miller AC, Hajiesmaieli M, Kangasniemi M, Alhani F, Jelvehmoghaddam H, Fathi M, Farzanegan B, Ardehali SH, Hatamian S, Gahremani M, Mosavinasab SM, Rostami Z, Madani SJ, Izadi M. Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial. Open Heart. 2016 Apr 19;3(1):e000349. doi: 10.1136/openhrt-2015-000349. eCollection 2016.
PubMed 27110376Vahedian-Azimi A, Sanjari MJ, Rahimi-Bashar F, Gohari-Mogadam K, Ouahrani A, Mustafa EMM, Ait Hssain A, Sahebkar A. Cardiac Rehabilitation Using the Family-Centered Empowerment Model is Effective in Improving Long-term Mortality in Patients with Myocardial Infarction: A 10-year Follow-Up Randomized Clinical Trial. High Blood Press Cardiovasc Prev. 2024 Mar;31(2):189-204. doi: 10.1007/s40292-024-00636-2. Epub 2024 Apr 2.
PubMed 38564167
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centered Empowerment Model With Four-stage Including Perceived Threat With Group Discussion Method, Self-efficacy With Problem Solving Method, Self-esteem With Educational Partnership, and Outcome and Process Evaluations
- ClinicalTrials.gov ID
- NCT02402582
- Acronym / sponsor ID
- BMSU
- Keywords
- Family-Centered Empowerment Model, Quality of life, Perceived stress, Anxiety, Myocardial infarction, Clinical trial, Iran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Tarbiat Modarres University
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 30 Mar 2015 (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 objective of this study was to evaluate the effectiveness of a FCEM-focused hybrid CR program for survivors of myocardial infarction (MI). The study sought to compare the long-term impact of FCEM-based intervention with a standard CR program in terms of mortality rates and different aspects of health related quality of life (HRQoL), which includes soft outcomes such as levels of stress, anxiety, psychological distress, quality of life (QoL), and hard outcomes such as the percentage of ejection fraction (EF), independent functioning, and functional exercise capacity status.
Detailed description
The investigators conducted a triple-blind randomized controlled clinical trial study in patients admitted for MI to the CCU of an academic teaching hospital from June 2012 to January 2023. The study was approved by the institutional investigative review board at Tarbiat Modares University and Baqiyatallah University of Medical Sciences. Patients were block randomized to receive either standard home cardiac rehabilitation (CR) or CR using the Family-centered Empowerment Model (FCEM) strategy. Patients had not previously gone through CR programs. The difference between the two groups was not disclosed at any point. Patients consented knowing that they would receive cardiac rehabilitation, but without knowing the details. Patients and their designated family/friend were enrolled as a 'unit'. Patient empowerment was measured with FCEM questionnaires pre-intervention and post-intervention for a total of 9 assessments. Quality-of-life, perceived stress, state and trait anxiety, psychological distress, independent functioning, and functional exercise capacity status were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, the 20-item State and 20-item Trait Anxiety questionnaires, Kessler Psychological Distress Scale,Barthel Index (BI) activities of daily living index, six-minute walk test (6MWT), and free walking index (FWI), respectively. In addition, echocardiography was used to measure ejection fraction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients had similar inpatient rehabilitation programs. Both groups exercised for 0-2h/day. Walking distance was measured using a Fitbit (Fitbit, San Francisco, USA). Routine care included education on smoking cessation and education on food selection. FCEM: Daily exercise occurred between 8-10 AM and was supervised by designated family members. Investigators randomly attended sessions in an unannounced fashion. Physical therapy consultation was available on investigator request. Exercise data were independently collected from the patient and their designated family member on a weekly basis (κ statistic=0.9). Control: Patients exercised daily, at any time. Sessions were supervised by family members. Investigators did not attend sessions. Exercise data were independently collected from the patient and their designated family member on a weekly basis (κ statistic=0.4).
| Arm | Type | Receives |
|---|---|---|
| Family-Centered Empowerment Model | Experimental | Other: Family-centered empowerment modelHave the same in-patient, pre-intervention, and post-intervention follow-up care as Control Group. However, rather than routine care and follow-up during the intervention period, they recieved than 4 stage intervention using the Family Centered Empowerment Model. |
| Control | Active comparator | Other: ControlSame in-patient, pre-intervention, and post-intervention follow-up care as Experimental Group. However, rather than 4 stage intervention they receive routine care and follow-up. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being within the age-range of 45 to 85 years old
- having the minimum literacy for reading and writing
- being hospitalized due to MI for the first time
- verification of MI by clinical symptoms
- enzyme-serum tests and cardiograph changes
Key exclusion criteria (1 listed)
- any offending items from mentioned criteria.
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 |
|---|---|---|
| Family-centered empowerment modelAlso: FCEMFCEM and Control groups had similar inpatient care. Patients in the intervention group received care employing the FCEM in four stages. Stage 1: Awareness and cognition. During 3-5 group sessions they were evaluated for their insight into their perceived illness severity and perceived sensitivity, or the degree to which they felt threatened by their illness. Stage 2: Expectations. 3-5 sessions. Stage 3: Acceptance. Assessed using an educational participation method in group discussion. Stage 4: Formative summative evaluations. The formative evaluation encourages patients to internalize their locus of control by seeing his/her self-empowerment (increasing self-responsibility about their health). Summative evaluations were performed to evaluate the influence of the intervention on HRQoL dimensions, perceived stress and anxiety -- assessed at baseline and at 3 months post-intervention. Empowerment was measured at baseline and at 10 days post-intervention by deploying FCEM questionnaires. | Other | Family-Centered Empowerment Model |
| ControlFCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up. | Other | Control |
Primary outcome
Mortality rate
Time frame: 10-year
5-year, 7-year, and 10-year mortality rates of MI survivors who received a FCEM-focused hybrid CR program as intervention group compared with those who received a standard CR program as control group
4 secondary outcomes
Patient Stress
Time frame: 48 months
Anxiety
Time frame: 48 months
Level of quality of life
Time frame: 48 months
psychological distress
Time frame: 48 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 6 Jun 2023.
- Results publication: PubMed 27110376Vahedian-Azimi A, Miller AC, Hajiesmaieli M, Kangasniemi M, Alhani F, Jelvehmoghaddam H, Fathi M, Farzanegan B, Ardehali SH, Hatamian S, Gahremani M, Mosavinasab SM, Rostami Z, Madani SJ, Izadi M. Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial. Open Heart. 2016 Apr 19;3(1):e000349. doi: 10.1136/openhrt-2015-000349. eCollection 2016.
- Derived from this study: PubMed 38564167Vahedian-Azimi A, Sanjari MJ, Rahimi-Bashar F, Gohari-Mogadam K, Ouahrani A, Mustafa EMM, Ait Hssain A, Sahebkar A. Cardiac Rehabilitation Using the Family-Centered Empowerment Model is Effective in Improving Long-term Mortality in Patients with Myocardial Infarction: A 10-year Follow-Up Randomized Clinical Trial. High Blood Press Cardiovasc Prev. 2024 Mar;31(2):189-204. doi: 10.1007/s40292-024-00636-2. Epub 2024 Apr 2.
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.
Amir vahedian-azimi, Resea fellow principal investigator
BMSU
Questions about this trial
What is this clinical trial studying?
A study testing Family-centered empowerment model in people with Acute Myocardial Infarction: Rehabilitation Phase, run by Baqiyatallah Medical Sciences University.
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 9 inclusion and 1 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality rate (time frame: 10-year). 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 NCT02402582, which also lists 2 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 6 Jun 2023.