Chronic pain self-management for older adults with cognitive impairment: A randomized pilot trial

患有认知障碍的老年人的慢性疼痛自我管理：一项随机试点试验

• 批准号: 10709192
• 负责人: Mary Rose Janevic
• 金额: $ 39万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709192
• 关键词: Acceleration; Address; Adult; Advocacy; Affect; African American; Age; Alzheimer' s disease related dementia; Americas; Analgesics; Behavior Therapy; Behavioral; Caregivers; Caring; Characteristics; Clinical; Cognition; Cognition Disorders; Cognitive; Cognitive deficits; Collaborations; Communities; Community Health Aides; Consultations; Data; Dementia; Development; Disadvantaged; Education; Educational Curriculum; Educational process of instructing; Elderly; Elements; Face; Feedback; Focus Groups; Goals; Impaired cognition; Individual; Infrastructure; Intervention; Interview; Low income; Measures; Memory; Methods; Michigan; Mind; Modeling; Older Population; Outcome; Pain; Pain intensity; Pain interference; Pain management; Parents; Participant; Persistent pain; Persons; Pharmaceutical Preparations; Phase; Physical activity; Pilot Projects; Population; Preparation; Process; Program Acceptability; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Resources; Risk; Rural; Sampling; Self Management; Symptoms; Techniques; Testing; Training; Transportation; Underserved Population; United States National Institutes of Health; Urban Community; Work; age related; caregiving; chronic musculoskeletal pain; chronic pain; chronic pain management; cognitive function; comorbidity; daily functioning; design; evidence base; executive function; experience; functional decline; high risk; implementation barriers; improved; insight; intervention refinement; low health literacy; member; mild cognitive impairment; non-drug; novel strategies; pain self-management; pain-related disability; patient engagement; pilot trial; population health; preference; primary outcome; process evaluation; programs; psychosocial; recruit; rural area; secondary outcome; skills; sleep health; social; telephone based; telephone session; treatment group; trend; urban setting; urban underserved

Project Summary Psychosocial interventions for chronic pain are largely untested in the growing segment of the older population living with mild cognitive impairment or early-stage Alzheimer’s disease and related dementias (MCI/ADRD). Chronic pain and cognitive impairment each exacerbate symptoms of the other, accelerating functional decline. While cognitive-behavioral strategies can improve pain-related functioning, standard interventions teaching these skills may not be effective in older adults with cognitive deficits. This proposed supplement will augment the work of the parent study, a randomized controlled trial of the STEPS chronic pain self-management intervention for underserved older adults, by modifying the intervention to be suitable for people living with MCI/ADRD. The original STEPS, delivered through telephone sessions with a community health worker, is already designed to address challenges common in low-income urban communities such as low health literacy, resource needs, and lack of transportation. The new version, called STEPS-CI, will offer simplified chronic pain education and modified processes for skill-building, and will connect participants to resources for MCI/ADRD and caregiving. Preparatory work for this supplement included: 1) interviews with experts about the pain management capabilities and needs of people with MCI/ADRD; and 2) focus groups with people living with chronic pain and MCI/ADRD. Findings confirmed the need for improved pain management skills in this population and yielded information about how STEPS could be tailored. The aims of this supplement are as follows: 1) Based on preliminary findings and in consultation with the newly formed STEPS-CI Advisory Council, modify the existing STEPS curriculum and program materials; and 2) Conduct a NIH Behavioral Intervention Stage 1 randomized pilot trial with 50 older adults (with optional care partners) who report chronic musculoskeletal pain and mild to moderate cognitive impairment, and assess its acceptability and preliminary effects on primary (pain interference) and secondary (pain intensity and subjective cognitive function) outcomes. Impact on pain medication use will be an exploratory outcome. Mixed methods will be used to evaluate key program processes including participant engagement, and to shed light on reasons for observed outcomes. Pilot study participants will be recruited from the same urban community as the parent trial (Detroit, MI), leveraging existing mechanisms; and, as an exploratory element, a subset of rural participants in northern Michigan will also be recruited, given the similarities in access barriers across these two underserved populations. The National Council of Dementia Minds, an advocacy and support organization led by people living with dementia, will advise on all study phases and processes through the STEPS-CI Advisory Council. This pilot study set the stage for a subsequent Stage 2 or 3 trial, if STEPS-CI is shown to be feasible and demonstrates potential efficacy; otherwise, it will provide valuable information leading to the development of alternative ways to meet the chronic pain management needs of older adults living with MCI/ADRD.

项目摘要 慢性疼痛的心理社会干预在越来越多的老年人口中基本上未经测试 患有轻度认知障碍或早期阿尔茨海默病和相关痴呆症（MCI/ADRD）。 慢性疼痛和认知障碍各自加剧对方的症状，加速功能衰退。 虽然认知行为策略可以改善疼痛相关功能，但标准干预教学 这些技能对于有认知缺陷的老年人可能无效。这一拟议的补充将增加 父母研究的工作，STEPS慢性疼痛自我管理的随机对照试验 对服务不足的老年人进行干预，修改干预措施，使其适合与 MCI/ADRD。最初的STEPS是通过与社区卫生工作者的电话会议提供的， 已经设计用于应对低收入城市社区的常见挑战，如健康素养低， 资源缺乏，交通不便。新版本名为STEPS-CI，将提供简化的慢性疼痛 教育和技能建设的修改过程，并将参与者连接到MCI/ADRD资源 和无意识的。本补充的准备工作包括：1）与专家就疼痛进行访谈 MCI/ADRD患者的管理能力和需求;以及2）与MCI/ADRD患者一起生活的重点群体 慢性疼痛和MCI/ADRD。研究结果证实，需要改善疼痛管理技能， 人口，并产生了关于如何调整STEPS的信息。这一补充的目的是 （1）根据初步调查结果并与新成立的STEPS-CI咨询委员会协商， 理事会，修改现有的STEPS课程和计划材料;和2）进行NIH行为 在50名老年人（有可选的护理伴侣）中进行的干预阶段1随机试点试验，这些老年人报告慢性 肌肉骨骼疼痛和轻度至中度认知障碍，并评估其可接受性和初步 对原发性（疼痛干扰）和继发性（疼痛强度和主观认知功能）的影响 结果。对止痛药使用的影响将是一项探索性结局。将采用混合方法， 评估关键的计划流程，包括参与者的参与，并阐明观察到的原因 结果。试点研究参与者将从与母公司试验相同的城市社区招募（底特律， 作为一项探索性内容，北方的一部分农村参与者参加了这项活动。 密歇根州也将被招募，因为这两个服务不足的地区的准入障碍相似 人口。全国痴呆症理事会是一个由人们领导的倡导和支持组织， 痴呆症患者，将通过STEPS-CI咨询理事会就所有研究阶段和过程提供建议。 如果STEPS-CI被证明是可行的， 展示了潜在的功效;否则，它将提供有价值的信息，从而促进 满足MCI/ADRD老年人慢性疼痛管理需求的替代方法。