Effect of Family-Centered Empowerment Model

Acute Myocardial Infarction: Rehabilitation Phase Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402582
• Other study ID #: BMSU
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2023
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 1, 2023
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction: Rehabilitation Phase
• Infarction
• Myocardial Infarction

Intervention

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.
• Control
FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	Tarbiat Modarres University

References & Publications (1)

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 Empowerme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ejection Fraction	Measured by trans-thoracic echocardiography	48 months
Other	Independent functioning	Barthel Index (BI) activities of daily living index	48 months
Other	Functional exercise capacity status	six-minute walk test (6MWT), and free walking index (FWI)	48 months
Primary	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	10-year
Secondary	Patient Stress	14-item Perceived Stress Questionnaire (PSQ-14)	48 months
Secondary	Anxiety	Beck 20-Item state and 20-Item trait anxiety Questionnaires	48 months
Secondary	Level of quality of life	the 36-Item Short Form Health Survey (SF-36)	48 months
Secondary	psychological distress	Psychological Distress Scale (K10)	48 months

External Links

•   "Open Heart" site for full text