Chronic Pain
Conditions
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.
Interventions
BEHAVIORALSTEP-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.
Sponsors
University of Michigan
Western Wayne Family Health Centers
National Institute on Aging (NIA)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference 6-item Subscale From PROMIS-43 Adult Profile | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Impression of Change in Pain | 8 weeks from baseline | How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). |
| Global Impression of Change in Functioning | 8 weeks from baseline | How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)). |
| Engagement as Measured by Number of Sessions Completed | 8 weeks from baseline | Number of sessions out of 6 completed 8 weeks from baseline |
| Participant Satisfaction | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.85 years STANDARD_DEVIATION 5.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 2 / 20 | 0 / 20 |
Outcome results
None listed