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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG022845-20 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Western Wayne Family Health Centers | UNKNOWN |
| National Institute on Aging (NIA) | NIH |
| Weill Medical College of Cornell University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEP-UP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Impression of Change in Pain | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks from baseline |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| unexplained bleeding | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Janevic | University of Michigan | (734) 647-3194 | mjanevic@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 | Dec 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2024 | Dec 5, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).
| 8 weeks from baseline |
| Engagement as Measured by Number of Sessions Completed | Number of sessions out of 6 completed 8 weeks from baseline | 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. | 8 weeks from baseline |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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. |
|
|
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| Secondary | Global Impression of Change in Pain | How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks from baseline |
|
|
|
| Secondary | Global Impression of Change in Functioning | How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks from baseline |
|
|
|
| Secondary | Engagement as Measured by Number of Sessions Completed | Number of sessions out of 6 completed 8 weeks from baseline | Posted | Mean | Standard Deviation | sessions | 8 weeks from baseline |
|
|
|
| Secondary | 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. | Participants who attended any intervention sessions | Posted | Mean | Standard Deviation | score on a scale | 8 weeks from baseline |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 1 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| hospitalization | Infections and infestations | Non-systematic Assessment |
|
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| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |