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

Overview

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.

Interventions

• Behavioral Strengthening COnnections to Overcome Pain (SCOOP)
  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.

Primary outcome measures

• Engagement as measured by number of sessions completed [Time frame: 8 weeks from baseline]

Secondary outcome measures (3)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT06671925 · HUM00261437 · P30AG022845

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗