跳至主要内容
临床试验/NCT06671925
NCT06671925
招募中
不适用

Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas

University of Michigan1 个研究点 分布在 1 个国家目标入组 80 人2026年1月27日

概览

阶段
不适用
干预措施
Strengthening COnnections to Overcome Pain (SCOOP)
疾病 / 适应症
Chronic Pain
发起方
University of Michigan
入组人数
80
试验地点
1
主要终点
Engagement as measured by number of sessions completed
状态
招募中
最后更新
上个月

概览

简要总结

The goal of this clinical trial is to test a new community health worker-delivered program (Strengthening COnnections to Overcome Pain, or SCOOP) that teaches strategies for managing chronic pain and loneliness to older adults living in rural areas. The main questions it aims to answer are:

  1. Does participating in SCOOP result in less pain interference with daily life?
  2. Does participating in SCOOP result in decreased loneliness?
  3. What is the level of participant engagement in SCOOP? Researchers will compare people who have participated in SCOOP with people who have not participated in SCOOP to see if SCOOP is helpful in decreasing pain interference and loneliness.

Participants will:

  1. Watch brief videos teaching strategies to manage pain and boost social connections.
  2. Engage in up to 7 weekly coaching sessions with a community health worker.
  3. Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.
注册库
clinicaltrials.gov
开始日期
2026年1月27日
结束日期
2027年5月31日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Mary Janevic

Research Associate Professor Department of Health Behavior and Health Equity University of Michigan School of Public Health

University of Michigan

入排标准

入选标准

  • Age \>= 60 years;
  • Have a mobile or landline phone;
  • 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);
  • Self-reported loneliness (Feeling lonely "some of the time" or more often);
  • Able to converse comfortably in English.

排除标准

  • Serious acute illness or hospitalization in the last month;
  • Planned major surgery in the next three months that would interfere with program participation (e.g., knee or hip replacement);
  • Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose a significant barrier to participation.

研究组 & 干预措施

SCOOP Intervention Group

SCOOP is a 7-week intervention, delivered primarily over the telephone by community health workers, to support chronic pain self-management and social connectedness.

干预措施: Strengthening COnnections to Overcome Pain (SCOOP)

Control group

Control group participants receive usual care between the baseline and 8-week follow-up survey. After completing the follow-up survey, control participants will be invited to take part in an educational workshop about pain and loneliness and will receive all intervention materials.

结局指标

主要结局

Engagement as measured by number of sessions completed

时间窗: 8 weeks from baseline

Number of sessions out of 7 that participants have completed 8 weeks from baseline.

次要结局

  • Participant satisfaction with the SCOOP intervention(8 weeks from baseline)
  • Change in Loneliness as measured by the UCLA 8-item Loneliness Scale(Baseline, 8 weeks from baseline)
  • Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile(Baseline, 8 weeks from baseline)

研究点 (1)

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