Chronic PainNCT06671925
A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults
A study testing Strengthening COnnections to Overcome Pain (SCOOP) in people with Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Strengthening COnnections to Overcome Pain (SCOOP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Rebecca Lindsay, MPH, 734-763-6369, reblin@umich.edu
Mary Janevic, PhD
About this study
Official title: Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas
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:
- Does participating in SCOOP result in less pain interference with daily life?
- Does participating in SCOOP result in decreased loneliness?
- 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.
Read more
Participants will:
- Watch brief videos teaching strategies to manage pain and boost social connections.
- Engage in up to 7 weekly coaching sessions with a community health worker.
- Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.
- Conditions
- Chronic Pain
- Being tested
- Strengthening COnnections to Overcome Pain (SCOOP)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening COnnections to Overcome Pain (SCOOP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement as measured by number of sessions completed
Number of sessions out of 7 that participants have completed 8 weeks from baseline.
Measured: 8 weeks from baseline
Secondary outcomes (3)
Participant satisfaction with the SCOOP intervention
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.
Measured: 8 weeks from baseline
Change in Loneliness as measured by the UCLA 8-item Loneliness Scale
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.
Measured: Baseline, 8 weeks from baseline
Change in Pain Interference 6-item subscale from PROMIS-43 Adult Profile
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.
Measured: Baseline, 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Jan 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Northern Michigan Health Consortium, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671925
- Sponsor's protocol ID
- HUM00261437
- Other IDs
- P30AG022845
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Loneliness in the Context of Chronic Pain Self-Management: An Intervention for Older Adults Living in Rural Areas
- ClinicalTrials.gov ID
- NCT06671925
- Acronym / sponsor ID
- HUM00261437
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Northern Michigan Health Consortium, University of Michigan
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does participating in SCOOP result in less pain interference with daily life?
- Does participating in SCOOP result in decreased loneliness?
- 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:
- Watch brief videos teaching strategies to manage pain and boost social connections.
- Engage in up to 7 weekly coaching sessions with a community health worker.
- Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCOOP Intervention Group | Experimental | Behavioral: Strengthening COnnections to Overcome Pain (SCOOP)SCOOP is a 7-week intervention, delivered primarily over the telephone by community health workers, to support chronic pain self-management and social connectedness. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SCOOP Intervention Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Related trials for Chronic Pain
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
Effects of Expectancy and Mindfulness Instructions on Chronic Pain
Chronic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic Pain, Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening COnnections to Overcome Pain (SCOOP) in people with Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary R. Janevic, PhD (734-647-3194, mjanevic@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement as measured by number of sessions completed (time frame: 8 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.