Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER)

单独 CBT 与丁丙诺啡比较的随机 ESRD 试验（恢复）

基本信息

批准号：
10614763
负责人：
Daniel Cukor
金额：
$ 62.14万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10614763
关键词：
Academic Medical Centers Acute Affect American American Indians Area Black race Buprenorphine Clinical Trials Clinical Trials Design Communities Coping Skills Data Diabetes Mellitus Dose Educational Intervention Educational Materials Elderly Elements End stage renal failure Enrollment Ensure Fracture Frequencies Funding General Population Generations Geography Goals Heart failure Helping to End Addiction Long-term Hemodialysis High Prevalence Hospitalization Individual Infrastructure Intervention Kidney Kidney Failure Latino Maintenance Motivation Multicenter Trials Musculoskeletal Neuropathy New Mexico New York Opioid Pacific Northwest Pain Pain interference Participant Patients Persons Population Population Heterogeneity Positioning Attribute Randomized Randomized Controlled Clinical Trials Readiness Reporting Research Research Personnel Risk Rural Community Safety Site Subgroup Symptoms Tablets Technology Testing Time Travel Universities Validity of Results Visual Washington Work adverse event risk chronic pain chronic pain management chronic pain patient clinical center cultural competence design digital digital health digital intervention disability effective therapy efficacy testing ethnic minority falls health literacy high risk improved low socioeconomic status mHealth metropolitan mortality opioid epidemic outreach pain reduction participant enrollment patient engagement physically handicapped prescription opioid racial and ethnic racial minority recruit remote communities rural area skills training telehealth trial comparing trial design urban area

项目摘要

PROJECT SUMMARY/ABSTRACT Over 60% of patients with kidney failure treated with long-term hemodialysis report chronic pain from highly prevalent musculoskeletal and neuropathic conditions. No clinical trial thus far has tested the efficacy and safety of treatments to manage chronic pain in this population. As such, the rate of opioid prescribing for people undergoing maintenance hemodialysis is 2-4 times higher than for the general population despite the significahtly higher risk for adverse events. The HEAL Initiative HOPE trial is a randomized controlled clinical trial designed to test the efficacy of pain coping skills training (PCST) to reduce pain interference and opioid prescribing for patients undergoing long-term hemodialysis. The HOPE trial seeks to enroll 640 participants from eight Clinical Centers composed of 16 enrolling sites; 327 participants have been enrolled to date. The consortium has successfully engaged patients from the outset and this has helped enroll a high proportion of Black and Latino participants. But major gaps remain in enrolling several key sub-groups. The trial is delivering the PCST intervention via telehealth; low motivational readiness and technology proficiency in many patients are posing as barriers to enrollment. Kidney failure disproportionately affects the elderly and those with physical and visual disabilities, sub-groups with high mobile health hesitancy and lower research participation. The current trial infrastructure also does not allow us to reach out to American Indian populations and rural communities, sub-groups with high prevalence of kidney failure and opioid prescribing. To bridge these gaps and ensure externally valid inferences, the University of Washington Clinical Center (sites in Albuquerque, NM, New York, NY, and Seattle, WA), the Scientific Data and Research Center (SDRC), and HOPE Trial Patient Advisory Group are requesting supplemental funds to enhance enrollment of three sub-groups of individuals – (1) those with mobile health hesitancy; (2) American Indians living in rural communities near Albuquerque, New Mexico; and (3) the geographically isolated community on the Kitsap and Olypmic Peninsulas near Seattle. The proposed strategies are responsive to the NOSI as we plan to (1) develop strategies to promote inclusion in HOPE, a study using digital interventions; (2) develop and disseminate study materials that are (digital) health literacy appropriate; (3) have culturally competent patient coordinators to facilitate outreach to and enrollment of American Indians; and (4) provide outreach to and accommodate patients with diverse travel needs such as those in remote communities. Importantly, the proposed work will accomplish its goals without increasing burden to the primary study. The SDRC will disseminate the educational materials to overcome mobile health hesitancy to all the 16 enrolling sites. The outreach efforts to American Indian communities and the Kitsap and Olympic Peninsulas will allow the UW Clinical Center to exceed its current enrollmet targets and this will help offset enrollment shortfalls at other Centers. Collectively, these efforts will further enhance patient engagement and allow the trial to enroll a more diverse population of participants for greater external validity.

项目摘要/摘要长期血液透析治疗的肾衰竭患者中，超过60％的患者报告了高度的慢性疼痛流行的肌肉骨骼和神经性疾病。迄今为止，尚无临床试验测试了效率和治疗治疗该人群慢性疼痛的安全。因此，阿片类药物处方率接受维护血液透析的人比一般人口目的地高2-4倍不良事件的更高风险。 Heal Initiative Hope试验是一个随机控制的临床旨在测试疼痛应对技巧培训（PCST）的效率以减少疼痛干扰和阿片类药物的试验针对接受长期血液透析的患者的处方。希望审判旨在注册640名参与者来自由16个入学地点组成的八个临床中心；迄今为止，已有327名参与者已入学。这联盟从一开始就成功地吸引了患者，这有助于招募很大一部分黑人和拉丁裔参与者。但是，在招募几个关键子组中仍然存在主要差距。审判正在交付通过远程医疗的PCST干预；许多患者的动机准备和技术水平低正构成入学障碍。肾脏衰竭不成比例地影响年长的人和身体和视觉障碍，移动健康犹豫较高的子群体和研究参与较低。当前的试验基础设施也不允许我们与美洲印第安人人口和农村接触社区，肾脏衰竭和阿片类药物处方的次数高。弥合这些差距并确保外部有效的推论，华盛顿大学临床中心（新墨西哥州阿尔伯克基的地点，纽约，纽约州和华盛顿州西雅图），科学数据与研究中心（SDRC），希望审判患者咨询小组要求补充资金，以增强三个个人的入学人数 - （1）具有移动健康健康的人；（2）居住在新的阿尔伯克基附近的农村社区的美洲印第安人墨西哥; （3）在西雅图附近的基萨普和原球半岛上的地理孤立社区。当我们计划（1）制定促进包容的策略时，提议的策略对NOSI有反应希望，一项使用数字干预措施的研究；（2）开发和传播研究材料（数字）健康素养适当；（3）具有文化合格的患者协调员，以促进与美国印第安人的入学；（4）提供外展和容纳多种旅行的患者需要偏远社区的需求。重要的是，拟议的工作将实现其目标增加烧伤对主要研究。 SDRC将传播教育材料以克服所有16个注册网站的移动健康健康。向美洲印第安人社区和 Kitsap和奥林匹克半岛将允许UW临床中心超过其当前的注册征兆目标和这将有助于抵消其他中心的入学率不足。总的来说，这些努力将进一步增强患者参与并允许试验招募更多的参与者，以提高外部有效性。