Treatment Options for Insomnia for ESRD

终末期肾病 (ESRD) 失眠的治疗选择

基本信息

批准号：
10320851
负责人：
RAJNISH MEHROTRA
金额：
$ 45.02万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-01-10 至 2023-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10320851
关键词：
American Behavior Therapy Behavioral Benzodiazepines Blinded Caring Chronic Disease Chronic Insomnia Clinical Data Clinical Trials Cognitive Therapy Collaborations Communities Computers Conduct Clinical Trials Country Data Coordinating Center Dialysis patients Dialysis procedure Drowsiness Drug usage Effectiveness Elderly End stage renal failure Evaluation Face Far East Fatigue Future Geographic Locations Group Therapy Health Health Benefit Health Services Accessibility Health Status Hemodialysis High Prevalence Hospitals Hour Individual Interdisciplinary Study Internet Intervention Kidney Failure Level of Evidence Life Maintenance Mental Depression Morbidity - disease rate New Mexico Outcome Pain Patient Outcomes Assessments Patient Self-Report Patient-Focused Outcomes Patients Persons Pharmaceutical Preparations Pharmacotherapy Placebos Population Positioning Attribute Procedures Property Protocols documentation Quality of life Randomized Controlled Clinical Trials Randomized Controlled Trials Recording of previous events Rehabilitation therapy Reporting Research Research Personnel Research Priority Risk Rural Community Safety Schedule Scientist Severities Sleep Sleep Disorders Sleep disturbances Sleeplessness Symptoms Telephone Interviews Testing Time Translating Trazodone Treatment Efficacy Treatment Protocols United States base clinical practice common symptom comparative effectiveness comparative efficacy depressive symptoms drug efficacy drug testing effective therapy efficacy testing experience falls frailty health care service utilization health related quality of life hemodynamics high risk improved mobile computing mortality mortality risk participant enrollment patient population recruit remote delivery response side effect telehealth telephone-based zolpidem

项目摘要

Project Summary/Abstract Patients with end-stage renal disease treated with hemodialysis (HD) report poor health-related quality life, in part because of the large number of troubling symptoms they experience. One of the most frequently reported such symptom is insomnia and includes patients' difficulties in falling asleep, frequently waking up after falling asleep, and early morning awakening. There are unique issues pertaining to HD treatments and schedules that disrupt regular sleep/wake routines and contribute to the high prevalence and severity of insomnia. A large body of evidence from HD patients and other populations also indicate that insomnia is associated with fatigue, daytime sleepiness, pain, depressive symptoms, and a higher risk for death. Despite evidence for broad- ranging health effects of insomnia, no clinical trials have tested the efficacy of treatments for HD patients. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as first line therapy but is inaccessible to HD patients in the United States as they have to commit to thrice weekly dialysis treatments in community- based dialysis facilities; CBT-I delivered by telehealth can overcome the barriers but its efficacy has never been rigorously tested for any patient population. Pharmacotherapy is the most widely used treatment for insomnia for HD patients - while some drugs presently used are unsafe as they are associated with a higher risk for death for this patient population (benzodiazepines and zolpidem-like drugs), the efficacy of others (trazodone) has never been tested for HD patients. With this application, we propose to test the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled clinical trial in which 125 HD patients with chronic insomnia treated in community-based dialysis facilities in Seattle and Albuquerque will be assigned 2:2:1 to telehealth CBT-I, trazodone, and medication placebo, respectively; short-term effectiveness will be determined at the end of 6-weeks of treatment and long-term effectiveness at 24-weeks. Telehealth CBT-I will be delivered through a mobile platform, iHOPE, by English and Spanish-speaking therapists. The primary and secondary patient reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment. The study will be conducted under the oversight of highly experienced Clinical and Data Coordinating Centers in Seattle with a strong track record of patient enrollment and retention in clinical trials, and implementing behavioral interventions with high fidelity to the protocol. This clinical trial will provide the first evidence for the comparative effectiveness of two distinct approaches in improving insomnia and other patient-reported outcomes for HD patients. It will also be the first rigorous evaluation of telehealth CBT-I, a readily scalable approach not only for HD patients but also for other patient populations with difficulty accessing treatment for insomnia.

项目摘要/摘要血液透析治疗（HD）治疗的终末期肾脏疾病的患者报告说，与健康相关的质量寿命差，部分原因是他们经历了大量令人不安的症状。最常报告的这种症状是失眠症，包括患者入睡的困难，经常在跌倒后醒来睡着了，清晨觉醒。与高清处理和时间表有关的独特问题破坏常规的睡眠/唤醒程序，并导致失眠的高患病率和严重程度。一个大 HD患者和其他人群的大量证据也表明失眠与疲劳有关，白天嗜睡，疼痛，抑郁症状和更高的死亡风险。尽管有广泛的证据由于失眠的健康影响，尚无临床试验测试了HD患者治疗的功效。建议对失眠的认知行为疗法（CBT-I）作为第一线治疗，但无法访问美国的高清患者必须承诺在社区中进行每周三次透析治疗基于透析设施；远程医疗提供的CBT-I可以克服障碍，但其功效从未对任何患者人群进行了严格的测试。药物治疗是最广泛使用的治疗方法高清患者的失眠 - 虽然目前使用的某些药物与较高的相关该患者人群死亡的风险（苯二氮卓类药物和类似唑吡坦的药物），其他人的疗效（曲唑酮）从未对HD患者进行测试。通过此应用程序，我们建议测试简短和远程医疗CBT-I，曲唑酮或药物治疗6周的长期比较有效性安慰剂。这将通过一项随机对照临床试验来完成，其中125例HD患者将分配在西雅图和阿尔伯克基的社区透析设施中治疗的慢性失眠症 2：2：1分别是远程医疗CBT-I，曲唑酮和药物安慰剂；短期有效性将是在6周的治疗和24周的长期有效性结束时确定。 Telehealth CBT-I Will 通过英语和讲西班牙语的治疗师通过移动平台IHOPE交付。主要和次要患者报告的结果将通过基于计算机的电话采访评估研究科学家对治疗作业视而不见。该研究将在高度监督下进行在西雅图经验丰富的临床和数据协调中心，并具有较强的患者入学记录并保留在临床试验中，并实施对协议高保真的行为干预措施。这临床试验将为两种不同方法的比较有效性提供第一个证据改善HD患者的失眠和其他患者报告的结果。这也将是第一个严格的评估远程医疗CBT-I，不仅适用于高清患者，而且针对其他患者的一种易于扩展的方法难以获得失眠治疗的人群。