Effect of Family-Centered Empowerment Model

June 4, 2023 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 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
10-year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ejection Fraction
Time Frame: 48 months
Measured by trans-thoracic echocardiography
48 months
Independent functioning
Time Frame: 48 months
Barthel Index (BI) activities of daily living index
48 months
Functional exercise capacity status
Time Frame: 48 months
six-minute walk test (6MWT), and free walking index (FWI)
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baqiyatallah Medical Sciences University

Collaborators

Tarbiat Modarres University

Investigators

  • Principal Investigator: Amir vahedian-azimi, Resea fellow, BMSU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimated)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 4, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMSU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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