Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02402582
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2015-03-20
Brief Title:
Effect of Family-Centered Empowerment Model
Sponsor:
Baqiyatallah Medical Sciences University
Organization:
Baqiyatallah Medical Sciences University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 familyfriend 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 ScaleBarthel 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None