NCT02402582

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

March 20, 2015

Last Update Submit

June 4, 2023

Conditions

Acute Myocardial Infarction: Rehabilitation Phase

Keywords

Family-Centered Empowerment ModelQuality of lifePerceived stressAnxietyMyocardial infarctionClinical trialIran

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient Stress

    48 months

  • Anxiety

    48 months

  • Level of quality of life

    48 months

  • psychological distress

    48 months

Other Outcomes (3)

  • Ejection Fraction

    48 months

  • Independent functioning

    48 months

  • Functional exercise capacity status

    48 months

Study Arms (2)

Family-Centered Empowerment Model

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Family-centered empowerment modelOTHER

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.

Also known as: FCEM
Family-Centered Empowerment Model
ControlOTHER

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

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • any offending items from mentioned criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27110376RESULT

  • Vahedian-Azimi A, Sanjari MJ, Rahimi-Bashar F, Gohari-Mogadam K, Ouahrani A, Mustafa EMM, Ait Hssain A, Sahebkar A. Cardiac Rehabilitation Using the Family-Centered Empowerment Model is Effective in Improving Long-term Mortality in Patients with Myocardial Infarction: A 10-year Follow-Up Randomized Clinical Trial. High Blood Press Cardiovasc Prev. 2024 Mar;31(2):189-204. doi: 10.1007/s40292-024-00636-2. Epub 2024 Apr 2.

    PMID: 38564167DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersMyocardial Infarction

Condition Hierarchy (Ancestors)

Mental DisordersMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Amir vahedian-azimi, Resea fellow

    BMSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Baqiyatallah Medical Sciences University

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 30, 2015

Study Start

June 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06