NCT06185101

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 14, 2023

Results QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 8 weeks from baseline

Secondary Outcomes (4)

  • Global Impression of Change in Pain

    8 weeks from baseline

  • Global Impression of Change in Functioning

    8 weeks from baseline

  • Engagement as Measured by Number of Sessions Completed

    8 weeks from baseline

  • Participant Satisfaction

    8 weeks from baseline

Study Arms (2)

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.

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.

Interventions

STEP-UPBEHAVIORAL

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.

Also known as: Support, Training, and Education for Pain self-management, Using Podcasts
STEP-UP intervention group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Palliative CareEducational Status

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Dr. Mary Janevic
Organization
University of Michigan

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 29, 2023

Study Start

May 2, 2024

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

January 26, 2026

Results First Posted

January 26, 2026

Record last verified: 2026-01

Locations