Chronic PainSTEPS-CINCT06182423
Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
A study testing STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version) in people with Chronic Pain and Cognitive Impairment, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Pain, Cognitive Impairment
- What is being tested?
- STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years;
- Have a cell or landline phone and internet access;
- Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >1 day/previous 30 when pain made it difficult to do usual activities.
- Self-reported mild cognitive impairment (MCI)/memory difficulties that at least sometimes interfere with usual daily activities
- Willingness to meet by phone or video with a community health worker to learn potentially new ways to manage pain and commit to the duration of the program
- Able to converse comfortably in English.
Who cannot join
- Serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement)
- Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder).
- Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.
- Conditions
- Chronic Pain, Cognitive Impairment
- Being tested
- STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)
- Medical subject headings
- Chronic Pain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)Behavioural
This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities.
| Study group | Role | What they receive |
|---|---|---|
| STEPS-CI Intervention Group | Experimental | Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker. Receives: Behavioral: STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version) |
| STEPS-CI Control Group | No intervention | Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Interference
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (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). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing a worse outcome. Change score represents [follow-up score - baseline score].
Measured: Baseline, 10 weeks from baseline
Secondary outcomes (2)
Change in Pain Intensity
A numeric rating scale of pain in the last week ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome). Change score represents [follow-up score - baseline score].
Measured: Baseline, 10 weeks from baseline
Change in Subjective Cognitive Functioning
The 4-item PROMIS Cognitive Function-Abilities Short Form 4a V. 2.0 measures perceived cognitive functioning in the last 4 days (e.g., "My mind has been as sharp as usual") on a scale from 1=not at all to 5=very much. 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 better cognitive functioning. Change score represents [follow-up score - baseline score].
Measured: Baseline, 10 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 posted26 Dec 2023
- Study start25 Jun 2024
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mary Janevic, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182423
- Sponsor's protocol ID
- HUM00237064
- Other IDs
- R01AG071511-02S1
- Acronym
- STEPS-CI
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2023
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT06182423
- Acronym / sponsor ID
- STEPS-CI / HUM00237064
- Conditions
- Chronic Pain, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Posted 22 May 2026
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 randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS-CI Intervention Group | Experimental | Behavioral: STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker. |
| STEPS-CI Control Group | No intervention | –Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 50 years;
- Have a cell or landline phone and internet access;
- Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >1 day/previous 30 when pain made it difficult to do usual activities.
- Self-reported mild cognitive impairment (MCI)/memory difficulties that at least sometimes interfere with usual daily activities
Key exclusion criteria (3 listed)
- Serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement)
- Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder).
- Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.
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 |
|---|---|---|
| STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version)This intervention is a community health worker (CHW)-led chronic pain self-management program designed for older adults with chronic pain and mild to moderate cognitive impairment. It is a 7-week intervention that includes two primary components: a website that includes brief instructional videos on pain management skills as well as testimonials from individuals living with the two target health conditions; and weekly telephone sessions with a CHW to support and motivate participants in setting goals related to pain management. Reminder strategies and content addressing pain management challenges related to cognitive impairment are incorporated throughout. Participants may choose to work with a care partner during intervention activities. | Behavioural | STEPS-CI Intervention Group |
Primary outcome
Change in Pain Interference
Time frame: Baseline, 10 weeks from baseline
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (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). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing a worse outcome. Change score represents [follow-up score - baseline score].
2 secondary outcomes
Change in Pain Intensity
Time frame: Baseline, 10 weeks from baseline
Change in Subjective Cognitive Functioning
Time frame: Baseline, 10 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS-CI (Support, Training, and Education for Pain Self-management- Cognitively Inclusive version) in people with Chronic Pain and Cognitive Impairment, run by University of Michigan 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 6 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: finished, as of the sponsor's last update on 22 May 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Interference (time frame: Baseline, 10 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 22 May 2026.