Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Engagement as measured by number of sessions completed
研究概览
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:
- Does participating in SCOOP result in less pain interference with daily life?
- Does participating in SCOOP result in decreased loneliness?
- 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:
- Watch brief videos teaching strategies to manage pain and boost social connections.
- Engage in up to 7 weekly coaching sessions with a community health worker.
- Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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) (Behavioral)
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
- Change in Loneliness as measured by the UCLA 8-item Loneliness Scale(Baseline, 8 weeks from baseline)
- 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)
研究者
Mary Janevic
Research Associate Professor Department of Health Behavior and Health Equity University of Michigan School of Public Health
University of Michigan