Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial (STEP-UP)

January 7, 2026 updated by: Mary Janevic, University of Michigan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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 the study team to pose a significant barrier to participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STEP-UP intervention group
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
Behavioral: STEP-UP
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.
Other Names:
  • Support, Training, and Education for Pain self-management, Using Podcasts
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Impression of Change in Pain
Time Frame: 8 weeks from baseline
How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)).
8 weeks from baseline
Global Impression of Change in Functioning
Time Frame: 8 weeks from baseline
How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).
8 weeks from baseline
Participant Satisfaction
Time Frame: 8 weeks from baseline
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.
8 weeks from baseline
Engagement as Measured by Number of Sessions Completed
Time Frame: 8 weeks from baseline
Number of sessions out of 6 completed 8 weeks from baseline
8 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
Weill Medical College of Cornell University
Western Wayne Family Health Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00240183
  • 5P30AG022845-20 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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