Trial Outcomes & Findings for Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial (NCT NCT06185101)
NCT ID: NCT06185101
Last Updated: 2026-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline, 8 weeks from baseline
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Support, Training, and Education for Pain Self-Management Using Podcasts: A Pilot Trial
Baseline characteristics by cohort
| Measure |
STEP-UP Intervention Group
n=20 Participants
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
Control Group
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.85 years
STANDARD_DEVIATION 5.81 • n=25 Participants
|
58.3 years
STANDARD_DEVIATION 6.12 • n=25 Participants
|
59.08 years
STANDARD_DEVIATION 5.94 • n=50 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=25 Participants
|
15 Participants
n=25 Participants
|
33 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
7 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
39 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
24 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
13 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks from baselineItems 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.
Outcome measures
| Measure |
STEP-UP Intervention Group
n=20 Participants
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Change in Pain Interference 6-item Subscale From PROMIS-43 Adult Profile
|
-3.3 score on a scale
Standard Deviation 7.8
|
-3.7 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 8 weeks from baselineHow participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)).
Outcome measures
| Measure |
STEP-UP Intervention Group
n=20 Participants
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Global Impression of Change in Pain
|
0.9 score on a scale
Standard Deviation 1.07
|
0.25 score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 8 weeks from baselineHow participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).
Outcome measures
| Measure |
STEP-UP Intervention Group
n=20 Participants
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
Control Group
n=20 Participants
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.
|
|---|---|---|
|
Global Impression of Change in Functioning
|
1.05 score on a scale
Standard Deviation 0.89
|
0.5 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: 8 weeks from baselineNumber of sessions out of 6 completed 8 weeks from baseline
Outcome measures
| Measure |
STEP-UP Intervention Group
n=20 Participants
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
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.
|
|---|---|---|
|
Engagement as Measured by Number of Sessions Completed
|
5.2 sessions
Standard Deviation 1.93
|
—
|
SECONDARY outcome
Timeframe: 8 weeks from baselinePopulation: Participants who attended any intervention sessions
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.
Outcome measures
| Measure |
STEP-UP Intervention Group
n=18 Participants
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
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.
|
|---|---|---|
|
Participant Satisfaction
|
4.33 score on a scale
Standard Deviation 0.59
|
—
|
Adverse Events
STEP-UP Intervention Group
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STEP-UP Intervention Group
n=20 participants at risk
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
Control Group
n=20 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
hospitalization
|
5.0%
1/20 • Number of events 1 • 8 weeks
|
0.00%
0/20 • 8 weeks
|
|
Infections and infestations
hospitalization
|
5.0%
1/20 • Number of events 1 • 8 weeks
|
0.00%
0/20 • 8 weeks
|
Other adverse events
| Measure |
STEP-UP Intervention Group
n=20 participants at risk
Participants will engage in a behavioral intervention for pain self-management that incorporates educational podcasts and sessions with a community health worker.
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.
|
Control Group
n=20 participants at risk
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.
|
|---|---|---|
|
General disorders
unexplained bleeding
|
5.0%
1/20 • Number of events 1 • 8 weeks
|
0.00%
0/20 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place