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NCT Number: NCT06671925

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Rebecca Lindsay, MPH

CONTACT

[email protected]

734-763-6369

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Engagement as measured by number of sessions completed

    Time frame: 8 weeks from baseline

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

Secondary outcomes

  1. Participant satisfaction with the SCOOP intervention

    Time frame: 8 weeks from baseline

    Items 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.

  2. Change in Loneliness as measured by the UCLA 8-item Loneliness Scale

    Time frame: 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.

  3. Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile

    Time frame: 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.

Other outcomes

  1. Global Impression of Change in Pain, Functioning, and Loneliness

    Time frame: 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)).

Study contacts

Contact information is provided by the study sponsor or research team.

Mary R. Janevic, PhD

CONTACT

[email protected]

734-647-3194

Rebecca Lindsay, MPH

CONTACT

[email protected]

734-763-6369

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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