Effect of Family-Centered Empowerment Model
Condition: Acute Myocardial Infarction: Rehabilitation Phase
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

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 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.
    

Intervention name(s): Family-centered empowerment model; Control
Intervention type(s): Other; Other
Intervention description(s): 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.; FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.
Other intervention name(s): FCEM
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
Keywords: Family-Centered Empowerment Model; Quality of life; Perceived stress; Anxiety; Myocardial infarction; Clinical trial; Iran