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临床试验/NCT04095650
NCT04095650已完成不适用

A New Model to Reach Vulnerable Older Adults With Pain Self-management Support

University of Michigan2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Change in pain interference

研究概览

简要总结

Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-proficient
  • Age >= 60 years
  • Ambulatory with or without assistive device
  • Community-living
  • Have a cell or landline phone
  • Have Internet access (home or elsewhere)
  • Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >4 (0-10 scale) average pain level over last week; >1 day/previous 30 when pain made it difficult to do usual activities
  • Ability to attend a one-time study orientation session

排除标准

  • Serious acute illness or hospitalization in last month
  • Planned surgery in next three months
  • Significant cognitive impairment as indicated by affirmative response to question: "Do you have significant difficulties with your memory that get in the way of your usual daily activities?"
  • Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.

结局指标

主要结局

Change in pain interference

时间窗: baseline and 8 weeks

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)..

Participant engagement

时间窗: 8 weeks

Number of completed sessions with the community health worker (range 1 to 7).

次要结局

  • Participant Global Impression of Change(8 weeks)
  • Participant satisfaction: Likert-scale questions(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Janevic

Assistant Research Scientist

University of Michigan

研究点 (2)

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