search
Back to results

Effect of Family-Centered Empowerment Model

Primary Purpose

Acute Myocardial Infarction: Rehabilitation Phase

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family-centered empowerment model
Control
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myocardial Infarction: Rehabilitation Phase focused on measuring Family-Centered Empowerment Model, Quality of life, Perceived stress, Anxiety, Myocardial infarction, Clinical trial, Iran

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Family-Centered Empowerment Model

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 20, 2015
    Last Updated
    June 4, 2023
    Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Tarbiat Modarres University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02402582
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 1, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Tarbiat Modarres University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction: Rehabilitation Phase
    Keywords
    Family-Centered Empowerment Model, Quality of life, Perceived stress, Anxiety, Myocardial infarction, Clinical trial, Iran

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Family-Centered Empowerment Model
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Family-centered empowerment model
    Other Intervention Name(s)
    FCEM
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.
    Primary Outcome Measure Information:
    Title
    Mortality rate
    Description
    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
    Time Frame
    10-year
    Secondary Outcome Measure Information:
    Title
    Patient Stress
    Description
    14-item Perceived Stress Questionnaire (PSQ-14)
    Time Frame
    48 months
    Title
    Anxiety
    Description
    Beck 20-Item state and 20-Item trait anxiety Questionnaires
    Time Frame
    48 months
    Title
    Level of quality of life
    Description
    the 36-Item Short Form Health Survey (SF-36)
    Time Frame
    48 months
    Title
    psychological distress
    Description
    Psychological Distress Scale (K10)
    Time Frame
    48 months
    Other Pre-specified Outcome Measures:
    Title
    Ejection Fraction
    Description
    Measured by trans-thoracic echocardiography
    Time Frame
    48 months
    Title
    Independent functioning
    Description
    Barthel Index (BI) activities of daily living index
    Time Frame
    48 months
    Title
    Functional exercise capacity status
    Description
    six-minute walk test (6MWT), and free walking index (FWI)
    Time Frame
    48 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amir vahedian-azimi, Resea fellow
    Organizational Affiliation
    BMSU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27110376
    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.
    Results Reference
    result
    Links:
    URL
    http://openheart.bmj.com/content/3/1/e000349
    Description
    "Open Heart" site for full text

    Learn more about this trial

    Effect of Family-Centered Empowerment Model

    We'll reach out to this number within 24 hrs