跳至主要内容
临床试验/NCT04715490
NCT04715490已完成不适用

Effects of a Multimedia Symptom Management Program on Coping Strategies, Symptom Distress, Depressive Status, and Quality of Life in Patients With Heart Failure: A Randomized Controlled Trial

Tri-Service General Hospital0 个研究点目标入组 78 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
主要终点
Minnesota Living with Heart Failure Questionnaire

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of a Multimedia Symptom Management Program on increasing coping strategies, reducing symptom distress and depression, and improving HRQoL in patients with HF.

详细描述

Design A single-blind two-group longitudinal experimental study will be conducted to compare a Multimedia Symptom Management Program with a usual care.

After receiving informed consents, participants will be randomly assigned to intervention and control groups at a 1:1 ratio. The intervention group will receive a Multimedia Symptom Management Program; the control group will receive usual care. Outcomes from four self-report questionnaires at 1 month and 3 months after initiating the intervention will be compared to baseline assessments. Outcome measurements include the following parameters: 28-item Brief COPE, Cardiac Symptom Survey (CSS), Beck Depression Inventory-II (BDI-II), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).

Inclusion and exclusion criteria The inclusion criteria are: (1) those who are ≥20 years old and HF diagnosed by a cardiology specialist, (2) have clear consciousness, (3) are fluent in Mandarin/Taiwanese. The exclusion criteria are: (1) diagnosed with any psychiatric disorder, (2) are addicting to drugs or alcohol at the time of the study, (3) are undergoing other psychotherapy during the study and (4) are refusing to participate in the study.

Recruitment Participants will be recruited from a cardiology outpatient clinic of a medical center in northern Taiwan. The study design and protocols had been reviewed and approved by the institutional review board of the participating hospital. At the content session, all assessments and procedures will be fully explained.

Assessment of eligibility and randomisation Participants will be considered eligible if they meet the inclusion criteria. All participants will be informed that they are able to withdraw from the study at any time. Before randomisation, participants will be asked to answer five questionnaires. The questionnaires include demographic characteristics, 28-item Brief COPE, Cardiac Symptom Survey (CSS), Beck Depression Inventory-II (BDI-II), and Minnesota Living with Heart Failure Questionnaire (MLHFQ). Participants will be randomly assigned to either the intervention group or the control group at a 1:1 ratio; randomization will be performed with the use of a computer-generated randomization scheme (SPSS software Version 23.0).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • those who are ≥20 years old and HF diagnosed by a cardiology specialist
  • have clear consciousness
  • are fluent in Mandarin/Taiwanese.

排除标准

  • diagnosed with any psychiatric disorder
  • are addicting to drugs or alcohol at the time of the study
  • are undergoing other clinical trial during the study
  • are refusing to participate in the study.

结局指标

主要结局

Minnesota Living with Heart Failure Questionnaire

时间窗: Change from quality of life at 3 months

次要结局

  • 28-item Brief COPE(Change from coping strategy at 3 months)
  • Cardiac Symptom Survey Questionnaire(Change from symptom distress at 3 months)
  • Beck Depression Inventory-II(Change from depressive status at 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fung-Wei Chang

Director, Head of Obstetrics and Gynecology, Clinical Professor

Tri-Service General Hospital

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