Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention

HIV 疲劳管理：睡眠和昼夜节律试点干预

• 批准号: 8789509
• 负责人: KATHRYN LEE
• 金额: $ 23.71万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8789509
• 关键词: Address; Adherence; Adult; Adverse effects; Affect; Age; Age-Years; Aging; Aging-Related Process; Anemia; Anti-Retroviral Agents; Anxiety; Attention; Beds; Behavior; Behavior Therapy; Behavioral; Chronic Disease; Circadian Rhythms; Clinical; Cognitive; Comorbidity; Complex; Control Groups; Diagnosis; Diet; Dimensions; Disease; Distress; Drowsiness; Drug Prescriptions; Elderly; Essential Drugs; Evidence based intervention; Exertion; Exposure to; Fatigue; Feeling; Frequencies; Future; Goals; HIV; HIV Infections; HIV Seropositivity; HIV therapy; Health; Individual; Intention; Intervention; Life; Longevity; Malaise; Measures; Medical; Mental Depression; Meta-Analysis; Modeling; Moods; Outcome; Participant; Patients; Pattern; Pharmaceutical Preparations; Pharmacotherapy; Physical Function; Pilot Projects; Population; Process; Psyche structure; Quality of life; Randomized; Randomized Clinical Trials; Regimen; Research; Research Design; Resort; Retirement; Sample Size; Sampling; Schedule; Severities; Sleep; Sleeplessness; Sunlight; Symptoms; Testing; Time; Viral Load result; awake; cognitive function; cost; depressive symptoms; design; disability; effective intervention; exhaustion; experience; group intervention; hypnotic; improved; medication compliance; post intervention; public health relevance; response; satisfaction; social; symptom management; treatment planning; trend

DESCRIPTION (provided by applicant): This application is in response to PA-13-211 calling for applications that address symptom management in HIV-infected older adults. This pilot study builds from our prior descriptive research with the HIV-positive population, where we found fatigue, lack of energy, or daytime sleepiness to be their most prevalent symptoms. Fatigue can vary from morning to night or across the social week, and can be measured by severity, frequency, or distress. Fatigue may be related to their chronic disease process, to side effects of drug therapy, or to insufficient sleep. Fatigue limits daytime function and can interfere with adherence to HIV drug therapy. Health-promoting behaviors that strengthen day/night circadian rhythms can improve fatigue without adding another medication to their therapy. In fact, sleep medications have many daytime side effects that include fatigue, inertia, malaise, sleepiness, lack of energy and subsequent insomnia. For this R21, we propose a pilot exploratory study designed as a randomized clinical trial to improve fatigue for adults diagnosed with HIV who are over 50 years of age without adding more medication. The overall aim is to test a brief behavioral intervention, the "Six Strategies for Fatigue" against an attentional control condition, "Dietary Actions to Diminish Fatigue" at 1, 2, and 3 months post- intervention. We will assess feasibility, satisfaction, and attrition issues in 60 participants (Aim 1). The goal is to show moderate to large effect sizes for reducing all dimensions of fatigue (Aim 2). We also expect small to moderate effect sizes and trends for reducing use of sleep medication, improving daytime function, and lowering anxiety and depressive symptoms (secondary aims). Analyses will be by intention-to-treat and we will use Linear Mixed Models to compare the two groups at four time points (baseline, 1, 2, and 3 months). Findings from this pilot study are essential for determining the optimal approach for moving forward to test this behavioral intervention in a larger sample of older HIV-infected adults. If effective, this intervention offers a non-pharmacologic and low-cost option to reduce fatigue as well as other symptoms associated with fatigue such as daytime sleepiness, depression and anxiety. By reducing fatigue in this chronic illness population, daytime function can be improved. This intervention also has high potential for treating fatigue in older adults with other types of complex chronic illness conditions.

描述（由申请人提供）：本申请是对 PA-13-211 的响应，该申请呼吁解决感染 HIV 的老年人的症状管理问题。这项试点研究建立在我们之前对艾滋病毒阳性人群进行的描述性研究的基础上，我们发现疲劳、精力不足或白天嗜睡是他们最常见的症状。疲劳从早到晚或在整个社交周中都会有所不同，并且可以通过严重程度、频率或痛苦来衡量。疲劳可能与他们的慢性疾病过程、药物的副作用有关。 药物治疗，或者睡眠不足。疲劳会限制白天的功能，并可能影响对艾滋病毒药物治疗的依从性。加强昼夜节律的促进健康的行为可以改善疲劳，而无需在治疗中添加其他药物。事实上，睡眠药物在白天有许多副作用，包括疲劳、惰性、不适、嗜睡、精力不足以及随后的失眠。对于这个 R21，我们提出了一项试点探索性研究，设计为一项随机临床试验，旨在改善 50 岁以上被诊断患有 HIV 的成年人的疲劳，而无需添加更多药物。总体目标是测试简短的行为干预，即针对注意力控制条件的“疲劳六种策略”， 干预后 1、2 和 3 个月的“减轻疲劳的饮食措施”。我们将评估 60 名参与者的可行性、满意度和人员流失问题（目标 1）。目标是显示降低各个方面的疲劳的中等到大的效果（目标 2）。我们还预计减少使用安眠药物、改善日间功能以及降低焦虑和抑郁症状（次要目标）的效果大小和趋势为小到中等。分析将按意向治疗进行，我们将使用线性混合模型在四个时间点（基线、1、2 和 3 个月）比较两组。这项试点研究的结果对于确定最佳方法至关重要，以便在更大的老年艾滋病毒感染者样本中测试这种行为干预措施。如果有效，这种干预措施将提供一种非药物且低成本的选择，以减轻疲劳以及与疲劳相关的其他症状，例如白天嗜睡、抑郁和焦虑。通过减少慢性病人群的疲劳，可以改善白天的功能。这种干预措施对于治疗患有其他类型复杂慢性疾病的老年人的疲劳也具有很大的潜力。