Effect of Family-Centered Empowerment Model

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction: Rehabilitation Phase
• Interventions: Other: Family-centered empowerment model; Other: Control

• Registration Number: NCT02402582
• Lead Sponsor: Baqiyatallah Medical Sciences University

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2015-01
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Study Completion: 2023-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-04
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-Centered Empowerment Model	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
Mortality rate	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

Secondary Outcome Measures

Name	Time	Method
Level of quality of life	48 months	the 36-Item Short Form Health Survey (SF-36)
Patient Stress	48 months	14-item Perceived Stress Questionnaire (PSQ-14)
psychological distress	48 months	Psychological Distress Scale (K10)
Anxiety	48 months	Beck 20-Item state and 20-Item trait anxiety Questionnaires