The Efficacy of the HIV/AIDS Symptom Management Manual
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 775
- 试验地点
- 21
- 主要终点
- Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
研究概览
简要总结
The goals of this research are: 1) To test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) To examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life.
The University of California, San Francisco is the coordinating site for this multi-site international study.
详细描述
People living with HIV/AIDS encounter many psychological, physiological, and cognitive symptoms, such as pain, diarrhea, fever, fatigue, depression, and confusion. These symptoms have been found to restrict a person's daily life significantly. Self-management of multiple HIV and medication side effects symptoms and maintaining optimal quality of life have, therefore, become major daily tasks for people living with HIV/AIDS.
This study is a randomized controlled trial with a two-group repeated measures design to test the efficacy of the symptom management manual. Two groups (experimental and control) will be assessed in a repeated measures design at 3 time points: baseline (time 0), one month (time 1), and two months (time 2). Data will be analyzed using longitudinal mixture modeling.
Comparison(s): HIV-positive patients receiving a symptom management manual and orientation to the manual, compared to HIV-positive patients receiving a nutrition manual and orientation to the manual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed HIV/AIDS
- •Adult (men and women, transgender)
- •Presence of at least one symptom within the past week
- •May or may not be pregnant
- •May or may not be on ART
- •Able to use the manual with or without family support
排除标准
- •Documented diagnosis of dementia
- •Unable to understand consent procedure as judged by the person getting consent
- •Self-reporting no symptoms within the past week
- •Self-reports having had experience with a self-care Symptom Management Manual
结局指标
主要结局
Degree of helpfulness (not at all, somewhat, very, extremely) of the symptom management manual at 1 month and 2 months.
时间窗: 1 month and 2 months
次要结局
- Change in quality of life.(1 month and 2 months)
- Change in adherence.(1 month and 2 months)
- Change in symptoms.(1 month and 2 months)