A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults

NCT06671925 | Recruiting

• 2 other identifiers: HUM00261437P30AG022845
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Does participating in SCOOP result in less pain interference with daily life?
2. 2.Does participating in SCOOP result in decreased loneliness?
3. 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.
4. 4.Watch brief videos teaching strategies to manage pain and boost social connections.
5. 5.Engage in up to 7 weekly coaching sessions with a community health worker.
6. 6.Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Engagement as measured by number of sessions completed

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

  8 weeks from baseline

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Global Impression of Change in Pain, Functioning, and Loneliness

  8 weeks from baseline

Study Arms (2)

SCOOP Intervention Group

EXPERIMENTAL

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

Behavioral: Strengthening COnnections to Overcome Pain (SCOOP)

Control group

NO INTERVENTION

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.

Interventions

Strengthening COnnections to Overcome Pain (SCOOP) BEHAVIORAL

Each week for 7 weeks, SCOOP intervention group participants will watch a brief video on the study website teaching a pain management or social connectedness skill and have a session with a community health worker, where they will receive support with behavioral goal-setting related to pain management and/or social connections. Participants will be screened for unmet social needs and connected to appropriate resources.

SCOOP Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Northern Michigan Health Consortium: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mary R. Janevic, PhD

CONTACT

734-647-3194; mjanevic@umich.edu

Rebecca Lindsay, MPH

CONTACT

734-763-6369; reblin@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor Department of Health Behavior and Health Equity University of Michigan School of Public Health

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 4, 2024
• Study Start: January 27, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)