Effects of the Self-management on Anxiety, Depression, Quality of Life and Self-management of Patients With Acute Coronary Syndromes: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale, HADS
研究概览
简要总结
Purpose :
The purpose of this study is to investigate the tracking effect of selfmanagement programs on anxiety, depression, and quality of life in patients with Acute Coronary Syndromes (ACS).
详细描述
Research Design :
This study the first phase is to construct and develop interventional measures for self-management of patients with ACS. According to the associated factors of study, the intervention measures are designed based on self-management. A pilot study will be conducted to improve research and to develop better selfmanagement interventions in the future. At the secondary stage: a randomized controlled trial with a random sampling design is used to investigate the effects of self-management programs on anxiety, depression, and quality of life in patients with ACS. The study will conduct in a cardiac medicine ward or coronary intensive care center of a north medical center. Patients with ACS,who met the conditions and agreed to join the study will be recruited. Then,the informed consent will be obtained. At the first stage, 10subjects will be collect. At the secondary stage, a total of 104 subjects will be enrolled, 52 in the experimental group will receive the self-management program, and 52 in the control group will receive a routine hospital care.
Method & Results:
The data of demographic and disease characteristics, clinical indicators,depression, anxiety, self-management, and quality of life will be collected.The Hospital Anxiety and Depression Scale, the SF-36 Taiwan version of the Quality-of-Life Questionnaire and the Self-Management Scale will used as tools to collect data. The efficacy of the intervention will be collected 1 month and 3 months after the intervention. Data will be statistically analyzed by GEE.
Hypothesis :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 20 years old
- •The first diagnosis of acute coronary syndrome by a clinician,
- •Clear consciousness, able to converse in Chinese and Taiwanese languages.
- •Willingness to participate in this research
排除标准
- •Those who are unable to take care of themselves
- •Poor vision and inability to read
- •Hard of hearing and deafness
- •Inability to communicate
研究组 & 干预措施
self-management interventions
self-management interventions: According to the results of literature search and based on the theory of self-efficacy, the intervention measures of the self-management program were designed.
regular care:regular care
干预措施: self-management (Other)
self-management interventions
self-management interventions: According to the results of literature search and based on the theory of self-efficacy, the intervention measures of the self-management program were designed.
regular care:regular care
干预措施: regular care (Other)
regular care
regular care
干预措施: regular care (Other)
结局指标
主要结局
Hospital Anxiety and Depression Scale, HADS
时间窗: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge.
The Likert four-point scale (0-3 points) was used, and the two items were scored separately, and the total score was between 0-21 points. The higher the score, the higher the degree of anxiety or depression. A score below 7 means no anxiety or depression, a score between 8 and 10 means the patient is suspected of anxiety or depression, and a score greater than or equal to 11 means that the patient has anxiety or depression. It is a measure to assess change at three-time points. change from Baseline Anxiety and Depression at 1 and 3 months.
The Partner In Health scale, PIH
时间窗: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge
Items in the scale are graded on a nine-point scale, with 0 representing the worst and 8 representing the best. This is a closed and continuous variable. The scale scores range from 0 to 96, with higher scores indicating better selfmanagement. It is a measure to assess change at three-time points. Change from self-management Baseline at 1 and 3 months.
The MOS 36-Item Short-Form Health Survey,SF36
时间窗: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge
Scores range from 0 to 100, with higher scores indicating better self-assessed health. Each item of the questionnaire is calculated separately according to the designed initial scores. Then the scores of the items related to each scale are added up and then subtracted from each scale to obtain the lowest score. Divide by the distance between the possible scores of each scale, and multiply by 100 to get the score. It is a measure to assess change at three-time points. change from Baseline quality of life at 1 and 3 months.
次要结局
未报告次要终点
研究者
Cheng, Hui- Chuan
Nursing Supervisor
Taipei Veterans General Hospital, Taiwan