Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in pain interference
研究概览
简要总结
The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years;
- •Have a cell or landline phone and internet access;
- •Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >1 day/previous 30 when pain made it difficult to do usual activities.
- •Self-reported mild cognitive impairment (MCI)/memory difficulties that at least sometimes interfere with usual daily activities
- •Willingness to meet by phone or video with a community health worker to learn potentially new ways to manage pain and commit to the duration of the program
- •Able to converse comfortably in English.
排除标准
- •Serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement)
- •Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder).
- •Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.
研究组 & 干预措施
STEPS-CI Control Group
Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.
STEPS-CI Intervention Group
Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.
干预措施: STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version) (Behavioral)
结局指标
主要结局
Change in pain interference
时间窗: Baseline, 10 weeks from baseline
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing a worse outcome.
次要结局
- Change in subjective cognitive functioning(Baseline, 10 weeks from baseline)
- Change in pain intensity(Baseline, 10 weeks from baseline)
研究者
Mary Janevic
Research Associate Professor
University of Michigan