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Effect of Family-Centered Empowerment Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02402582
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : July 3, 2018
Tarbiat Modarres University
Information provided by (Responsible Party):
Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

Brief Summary:
The objective of this study was to determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality-of-life, perceived stress and state anxiety of patients with myocardial infarction (MI).

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction: Rehabilitation Phase Other: Family-centered empowerment model Other: Control Not Applicable

Detailed Description:
The investigators conducted a randomized controlled blinded study in patients admitted for MI to the CCU of an academic teaching hospital from June 2012 to January 2015. 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, and state and trait anxiety were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, and the 20-item State and 20-item Trait Anxiety questionnaires, respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Family-Centered Empowerment Model
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.
Other: Family-centered empowerment model
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.
Other Name: FCEM

Active Comparator: Control
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.
Other: Control
FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.

Primary Outcome Measures :
  1. Patient quality of life as measured by the SF-36 [ Time Frame: 32 months ]
    36-Item Short Form Health Survey (SF-36)

Secondary Outcome Measures :
  1. Patient Stress [ Time Frame: 32 months ]
    14-item Perceived Stress Questionnaire (PSQ-14)

  2. Anxiety [ Time Frame: 32 months ]
    Beck 20-Item state and 20-Item trait anxiety Questionnaires

Other Outcome Measures:
  1. Ejection Fraction [ Time Frame: 32 ]
    Measured by trans-thoracic echocardiography

  2. Exercise Tolerance [ Time Frame: 32 months ]
    Walking Distance

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • patients' willingness toward participating in the research
  • having no psychological problems
  • ability to fill out the questionnaire and participating in the empowerment program.

Exclusion Criteria:

  • any offending items from mentioned criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02402582

Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Tarbiat Modarres University
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Principal Investigator: Amir vahedian-azimi, Resea fellow BMSU
Additional Information:
Publications of Results:
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Responsible Party: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University Identifier: NCT02402582    
Other Study ID Numbers: BMSU
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Keywords provided by Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University:
Family-Centered Empowerment Model
Quality of life
Perceived stress
Myocardial infarction
Clinical trial
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases