A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults
- Conditions
- Chronic Pain
- Registration Number
- NCT06671925
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile Baseline, 8 weeks from baseline 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). Scores are converted to a standardized T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
- Secondary Outcome Measures
Name Time Method Change in Loneliness as measured by the UCLA 8-item Loneliness Scale Baseline, 8 weeks from baseline Eight items ask about feelings of loneliness and social isolation. Each question is rated on a 4-point scale: 1=never, 2=rarely, 3=sometimes, and 4 =always. Two positively worded items ("I am an outgoing person" and "I can find companionship when I want it" are reverse-scored. All items are summed to give a total score of 8 to 32 points. A higher score indicates a greater degree of loneliness.
Engagement as measured by number of sessions completed 8 weeks from baseline Number of sessions out of 7 that participants have completed 8 weeks from baseline.
Global Impression of Change in Pain, Functioning, and Loneliness 8 weeks from baseline Three items, analyzed separately: 1) How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). 2) How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)). 3) How participant thinks their feelings of loneliness have changed from baseline (much worse (-3) to much better(+3)).
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States