Skip to main content
OpenTrials
Completed

NCT Number: NCT02402582

Effect of Family-Centered Empowerment Model

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction: Rehabilitation Phase Anxiety Disorders Cardiovascular Diseases Heart Diseases Infarction Ischemia Mental Disorders Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family-centered empowerment model

Other

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

Control

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient Stress

    Time frame: 48 months

    14-item Perceived Stress Questionnaire (PSQ-14)

  2. Anxiety

    Time frame: 48 months

    Beck 20-Item state and 20-Item trait anxiety Questionnaires

  3. Level of quality of life

    Time frame: 48 months

    the 36-Item Short Form Health Survey (SF-36)

  4. psychological distress

    Time frame: 48 months

    Psychological Distress Scale (K10)

Other outcomes

  1. Ejection Fraction

    Time frame: 48 months

    Measured by trans-thoracic echocardiography

  2. Independent functioning

    Time frame: 48 months

    Barthel Index (BI) activities of daily living index

  3. Functional exercise capacity status

    Time frame: 48 months

    six-minute walk test (6MWT), and free walking index (FWI)

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Collaborators

  • Tarbiat Modarres University

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2023
First posted
Mar 30, 2015
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.