Clinical trial NCT06671925: A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults
Official title: Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Northern Michigan Health Consortium
name: Weill Medical College of Cornell University
First posted: 2024-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile
timeFrame: Baseline, 8 weeks from baseline
Secondary outcomes:
measure: Change in Loneliness as measured by the UCLA 8-item Loneliness Scale
timeFrame: Baseline, 8 weeks from baseline
measure: Engagement as measured by number of sessions completed
timeFrame: 8 weeks from baseline
measure: Global Impression of Change in Pain, Functioning, and Loneliness
timeFrame: 8 weeks from baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: