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临床试验/NCT02402582
NCT02402582已完成不适用

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

Baqiyatallah Medical Sciences University0 个研究点目标入组 70 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
主要终点
Mortality rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • any offending items from mentioned criteria.

结局指标

主要结局

Mortality rate

时间窗: 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

次要结局

  • Level of quality of life(48 months)
  • Patient Stress(48 months)
  • psychological distress(48 months)
  • Anxiety(48 months)

研究者

发起方
Baqiyatallah Medical Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Vahedian-Azimi

Baqiyatallah Medical Sciences University

Baqiyatallah Medical Sciences University

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