Chronic PainSTEP-UPNCT06185101
Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial
A study testing STEP-UP in people with Chronic Pain, run by University of Michigan at 1 site in United States.
Trial summary
This randomized Stage 1 pilot trial tests the feasibility of a community health worker (CHW) delivered chronic pain self-management intervention for older adults ("STEP-UP"; Support, Training, and Education for Pain Self-Management - Using Podcasts) in a primary care setting. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- STEP-UP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 29 Jan 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 mobile or landline phone
- Report high-impact chronic musculoskeletal pain (defined as pain in muscles or joints for > 3 months "most days" or "every day" on a scale of never, some days, most days, or every day) AND their pain limited life or work activities over the past 3 months "most days" or "every day"
- Have not participated in another chronic pain self-management intervention in the last 5 years.
- 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 the study team to pose a significant barrier to participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of a Chronic Pain Self-management Intervention for Older Adults Incorporating Podcasts and Patient Priorities
This randomized Stage 1 pilot trial tests the feasibility of a community health worker (CHW) delivered chronic pain self-management intervention for older adults ("STEP-UP"; Support, Training, and Education for Pain Self-Management - Using Podcasts) in a primary care setting. A total of 40 participants aged 50+ with high-impact chronic pain will be randomized to intervention or control groups. The STEP-UP intervention will feature an educational podcast series teaching core pain self-management skills. Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period. The Community Health Worker will guide participants in a modified Patient Priorities of Care approach to help them identify their values and priorities and develop goals that reflect these.
- Conditions
- Chronic Pain
- Being tested
- STEP-UP
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEP-UPBehavioural
Also called Support, Training, and Education for Pain self-management, Using Podcasts
The STEP-UP chronic pain self-management intervention (Support, Training, and Education for Pain Self-Management - Using Podcasts) will feature an educational podcast series teaching core pain self-management skills. Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period. The Community Health Worker will guide participants in a modified Patient Priorities of Care (PPC) approach to help them identify their values and priorities and develop goals that reflect these.
| Study group | Role | What they receive |
|---|---|---|
| STEP-UP intervention group | Experimental | Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker. Receives: Behavioral: STEP-UP |
| Control group | No intervention | Members of the control group will not initially receive the STEP-UP intervention. After completing the 8-week follow-up telephone survey, individuals in the control group will be invited to take part in the STEP-UP intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Change scores are calculated as [8 week score] - [baseline score]; therefore, a greater negative value means a greater reduction in pain interference.
Measured: Baseline, 8 weeks from baseline
Secondary outcomes (4)
Global Impression of Change in Pain
How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)).
Measured: 8 weeks from baseline
Global Impression of Change in Functioning
How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).
Measured: 8 weeks from baseline
Engagement as Measured by Number of Sessions Completed
Number of sessions out of 6 completed 8 weeks from baseline
Measured: 8 weeks from baseline
Participant Satisfaction
Items ask about overall satisfaction with the program, e.g., whether participation increased understanding of pain management (1= Strongly Disagree to 5= Strongly Agree). A higher score indicates higher patient satisfaction.
Measured: 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 posted29 Dec 2023
- Study start2 May 2024
- Primary completion29 Jan 2025
- Study completion29 Jan 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Western Wayne Family Health Centers, National Institute on Aging (NIA), Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Mary Janevic, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185101
- Sponsor's protocol ID
- HUM00240183
- Other IDs
- 5P30AG022845-20
- Acronym
- STEP-UP
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2023
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Chronic Pain Self-management Intervention for Older Adults Incorporating Podcasts and Patient Priorities
- ClinicalTrials.gov ID
- NCT06185101
- Acronym / sponsor ID
- STEP-UP / HUM00240183
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Western Wayne Family Health Centers, National Institute on Aging (NIA), Weill Medical College of Cornell University
- Study start
- 2 May 2024 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized Stage 1 pilot trial tests the feasibility of a community health worker (CHW) delivered chronic pain self-management intervention for older adults ("STEP-UP"; Support, Training, and Education for Pain Self-Management - Using Podcasts) in a primary care setting. A total of 40 participants aged 50+ with high-impact chronic pain will be randomized to intervention or control groups. The STEP-UP intervention will feature an educational podcast series teaching core pain self-management skills. Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period. The Community Health Worker will guide participants in a modified Patient Priorities of Care approach to help them identify their values and priorities and develop goals that reflect these.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEP-UP intervention group | Experimental | Behavioral: STEP-UPParticipants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker. |
| Control group | No intervention | –Members of the control group will not initially receive the STEP-UP intervention. After completing the 8-week follow-up telephone survey, individuals in the control group will be invited to take part in the STEP-UP intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 50 years
- Have a mobile or landline phone
- Report high-impact chronic musculoskeletal pain (defined as pain in muscles or joints for > 3 months "most days" or "every day" on a scale of never, some days, most days, or every day) AND their pain limited life or work activities over the past 3 months "most days" or "every day"
- Have not participated in another chronic pain self-management intervention in the last 5 years.
- 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 the 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 |
|---|---|---|
| STEP-UPAlso: Support, Training, and Education for Pain self-management, Using PodcastsThe STEP-UP chronic pain self-management intervention (Support, Training, and Education for Pain Self-Management - Using Podcasts) will feature an educational podcast series teaching core pain self-management skills. Podcasts will be supplemented by sessions with a Community Health Worker taking place at designated times over a 7-week period. The Community Health Worker will guide participants in a modified Patient Priorities of Care (PPC) approach to help them identify their values and priorities and develop goals that reflect these. | Behavioural | STEP-UP intervention group |
Primary outcome
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. Change scores are calculated as [8 week score] - [baseline score]; therefore, a greater negative value means a greater reduction in pain interference.
4 secondary outcomes
Global Impression of Change in Pain
Time frame: 8 weeks from baseline
Global Impression of Change in Functioning
Time frame: 8 weeks from baseline
Engagement as Measured by Number of Sessions Completed
Time frame: 8 weeks from baseline
Participant Satisfaction
Time frame: 8 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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 STEP-UP in people with Chronic Pain, 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 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: finished, as of the sponsor's last update on 26 Jan 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 26 Jan 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 6-item Subscale From PROMIS-43 Adult Profile (time frame: Baseline, 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 26 Jan 2026.