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.

项目概要/摘要超过 60% 接受长期血液透析治疗的肾衰竭患者报告因高度疲劳而出现慢性疼痛迄今为止，尚未有临床试验测试其功效和作用。治疗该人群慢性疼痛的安全性因此，阿片类药物的处方率。尽管接受维持性血液透析的人数比一般人群高出 2-4 倍 HEAL Initiative HOPE 试验是一项随机对照临床试验。旨在测试疼痛应对技能训练 (PCST) 减少疼痛干扰和阿片类药物效果的试验 HOPE 试验旨在招募 640 名参与者。来自由 16 个招募点组成的 8 个临床中心；迄今为止已招募了 327 名参与者。联盟从一开始就成功地吸引了患者，这有助于招募高比例的患者但黑人和拉丁裔参与者在招募几个关键群体方面仍存在重大差距。通过远程医疗进行 PCST 干预；许多患者的动机准备度和技术熟练程度较低；肾衰竭对老年人和患有肾功能衰竭的人造成了不成比例的影响。身体和视力残疾、对移动健康犹豫不决和研究参与度较低的亚群体。目前的试验基础设施也不允许我们接触美洲印第安人和农村人口肾衰竭和阿片类药物处方患病率较高的社区、亚群体弥合这些差距。并确保外部有效的推论，华盛顿大学临床中心（位于新墨西哥州阿尔伯克基，纽约州纽约市和华盛顿州西雅图市）、科学数据和研究中心 (SDRC) 以及 HOPE 试验患者咨询小组正在请求补充资金，以提高三个亚组个人的入学率 - (1) 对移动健康犹豫不决的人；(2) 居住在新州阿尔伯克基附近农村社区的美国印第安人墨西哥；(3) 西雅图附近基萨普半岛和奥林匹克半岛上地理上孤立的社区。拟议的战略是对 NOSI 的回应，因为我们计划 (1) 制定促进包容性的战略 HOPE 是一项使用数字干预的研究；(2) 开发和传播（数字）研究材料适当的健康素养；(3) 拥有具有文化能力的患者协调员，以促进外展活动；美洲印第安人的登记；(4) 为不同旅行的患者提供服务和住宿；重要的是，拟议的工作将在不影响偏远社区的需求的情况下实现其目标。国家发展和改革委员会将分发教材以克服这一问题。对所有 16 个注册地点的移动医疗犹豫不决对美洲印第安人社区和地区的外展工作。基萨普和奥林匹克半岛将使威斯康星大学临床中心能够超越其当前的招生目标这将进一步帮助弥补其他中心的入学缺口。总的来说，这些努力将增强患者的数量。参与并允许试验招募更多样化的参与者群体，以获得更大的外部有效性。