Effect of Family-Centered Empowerment Model
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|ClinicalTrials.gov Identifier: NCT02402582|
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction: Rehabilitation Phase||Other: Family-centered empowerment model Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||June 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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 Name: 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.
FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.
- Patient quality of life as measured by the SF-36 [ Time Frame: 32 months ]36-Item Short Form Health Survey (SF-36)
- Patient Stress [ Time Frame: 32 months ]14-item Perceived Stress Questionnaire (PSQ-14)
- Anxiety [ Time Frame: 32 months ]Beck 20-Item state and 20-Item trait anxiety Questionnaires
- Ejection Fraction [ Time Frame: 32 ]Measured by trans-thoracic echocardiography
- Exercise Tolerance [ Time Frame: 32 months ]Walking Distance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402582
|Principal Investigator:||Amir vahedian-azimi, Resea fellow||BMSU|