Clinical trial NCT02402582: Effect of Family-Centered Empowerment Model
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction: Rehabilitation Phase
Keywords: Family-Centered Empowerment Model
Quality of life
Perceived stress
Anxiety
Myocardial infarction
Clinical trial
Iran
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Tarbiat Modarres University
First posted: 2015-03-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality rate
timeFrame: 10-year
Secondary outcomes:
measure: Patient Stress
timeFrame: 48 months
measure: Anxiety
timeFrame: 48 months
measure: Level of quality of life
timeFrame: 48 months
measure: psychological distress
timeFrame: 48 months
Other outcomes:
measure: Ejection Fraction
timeFrame: 48 months
measure: Independent functioning
timeFrame: 48 months
measure: Functional exercise capacity status
timeFrame: 48 months
Locations:
Study officials:
affiliation: BMSU
name: Amir vahedian-azimi, Resea fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.