Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Lack of energy - severity
研究概览
简要总结
This randomized clinical trial (RCT) pilot study as two main objectives:
- determine the overall feasibility of a behavioral intervention for managing fatigue among older adults with HIV infection.
- to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions of fatigue.
The investigators hypothesize that adherence, satisfaction, and attrition will be similar for the active intervention group and the attention control group. The investigators also hypothesize that all five dimensions will improve in the intervention group compared to controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5 SD units for all five fatigue dimensions at all three post-intervention time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of HIV infection
- •Be at least 50 years of age
- •Have a Fatigue Severity Score13 > 4.0
- •Be retired or on disability
- •Be willing to wear a FitBit One Tracker and keep a 7-day diary at 4 time points (electronic, paper, or other convenient format)
- •Be able to speak, understand, and read English
- •Have a telephone, cell phone, computer access, or other means of communication
排除标准
- •Current temporary, part-time, or full-time employment
- •Planning to travel or be away from home during the 3-month study time frame
- •Being pre- or peri-menopausal because of fluctuations in vasomotor symptoms over time
- •Taking hormones to treat symptoms of menopause
- •Brief Interview for Mental Status score < 13
- •AIDS dementia diagnosis
- •Diagnosed sleep disorder that would not be responsive to behavioral interventions (sleep apnea, restless legs, etc.).
结局指标
主要结局
Lack of energy - severity
时间窗: 3 months
self-report rating of the severity of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)
Morning fatigue severity
时间窗: 3 months
self-report ratings of morning fatigue severity (Lee Fatigue Scale)
Lack of energy - distress
时间窗: 3 months
self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale)
Attrition
时间窗: 3 months
Proportion of participants who do not complete the study
Evening fatigue severity
时间窗: 3 months
self-report ratings of evening fatigue severity (Lee Fatigue Scale)
Lack of energy - frequency
时间窗: 3 months
self-report rating of the frequency of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)
Satisfaction with the intervention
时间窗: 3 months
Ratings of participant satisfaction with the 6 intervention components
Adherence to intervention
时间窗: 3 months
Self-reported adherence to each of the 6 behavioral intervention components
次要结局
- Cognitive function(3 months)
- Sleep behavior(3 months)
- Physical function(3 months)
- Objectively measured sleep duration(3 months)
- Objectively-measured activity(3 months)
- Depressed mood(3 months)
- Objectively measured sleep quality(3 months)
- Self-reported sleep quality(3 months)
- Anxious mood(3 months)
- Medication adherence(3 months)
- Daytime sleepiness(3 months)
- Sleep medication use(3 months)
- Fatigue interference with daytime function(3 months)