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

Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06671925
Enrollment
80
Registered
2024-11-04
Start date
2026-01-27
Completion date
2027-05-31
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

BEHAVIORALStrengthening 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.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Northern Michigan Health Consortium
CollaboratorUNKNOWN
University of Michigan
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Engagement as measured by number of sessions completed8 weeks from baselineNumber of sessions out of 7 that participants have completed 8 weeks from baseline.

Secondary

MeasureTime frameDescription
Participant satisfaction with the SCOOP intervention8 weeks from baselineItems ask about overall satisfaction with the program, i.e., whether participation increased understanding of pain management and increased knowledge of strategies to improve social connection (1= Strongly Disagree to 5= Strongly Agree). The mean of the two items will be calculated. A higher score indicates greater participant satisfaction with the intervention.
Change in Loneliness as measured by the UCLA 8-item Loneliness ScaleBaseline, 8 weeks from baselineEight 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.
Change in Pain Interference 6-item subscale from PROMIS-43 Adult ProfileBaseline, 8 weeks from baselineItems 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.

Countries

United States

Contacts

CONTACTMary R. Janevic, PhD
mjanevic@umich.edu734-647-3194
CONTACTRebecca Lindsay, MPH
reblin@umich.edu734-763-6369
PRINCIPAL_INVESTIGATORCary Reid, MD, PhD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026