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| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG022845-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Weill Medical College of Cornell University | OTHER |
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Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a randomized pilot and feasibility trial of a positive psychology-based chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 50 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants will engage in a 7-week positive psychology-based chronic pain self-management program. |
|
| Usual care control group | No Intervention | After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive STEPS | Behavioral | Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They can choose to report daily step counts either by automatically syncing to an app or by manual reporting via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants will also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Interference | The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (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). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome. | Baseline and 8 weeks |
| Change in Self-reported Physical Functioning | The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Global Impression of Change--Pain | How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome. | Baseline and 8 weeks |
| Change in Pain Self-efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Janevic, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35394525 | Derived | Janevic M, Robinson-Lane SG, Courser R, Brines E, Hassett AL. A Community Health Worker-Led Positive Psychology Intervention for African American Older Adults With Chronic Pain. Gerontologist. 2022 Oct 19;62(9):1369-1380. doi: 10.1093/geront/gnac010. |
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Data will be available for sharing upon the date of online publication of the results of the primary aims.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants will engage in a 7-week positive psychology-based chronic pain self-management program. Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker. |
| FG001 | Usual Care Control Group | After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who were randomized to a treatment condition and completed baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants will engage in a 7-week positive psychology-based chronic pain self-management program. Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age data not available for one participant |
| 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 | The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (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). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome. | Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome. | Posted | Mean | Standard Deviation | T-score | Baseline and 8 weeks |
|
Two months
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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 | Intervention Group | Participants will engage in a 7-week positive psychology-based chronic pain self-management program. Positive STEPS: Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They will report daily step counts via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants may also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant had a fall; was determined to be unrelated to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | Jul 1, 2020 | Aug 19, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2020 | Aug 19, 2021 | 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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|
The Pain Self-Efficacy Questionnaire, a 10-item scale (Nicholas 1989) rating confidence at doing specific things (e.g., chores, accomplishing goals, becoming more active) despite pain; each item scored from 0=not at all confident to 6=completely confident.
| Baseline and 8 weeks |
| Change in Social Participation | Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome. | Baseline and 8 weeks |
| Change in Resilience | 10-item version of the Connor-Davidson resilience scale rating the degree (0=not true at all to 4=true nearly all the time) respondent can cope/be resilient in various situations. Higher score means more resilience. | Baseline and 8 weeks |
| Participant Global Impression of Change - Functioning | How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome. | 8 weeks |
| BG001 | Usual Care Control Group | After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Pain interference (PROMIS 6-item scale) | The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (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). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome. | Two participants had missing data on this measure. | Mean | Standard Deviation | T-score |
|
| Physical functioning (PROMIS 4-item scale) | The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome. | Mean | Standard Deviation | T-score |
|
| Social participation (PROMIS 4-item scale) | Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome. | Missing data (missing items) on this measure for a total of 4 participants. | Mean | Standard Deviation | T-score |
|
| Resilience (Connor-Davidson 10-item scale) | 10-item version of the Connor-Davidson resilience scale rating the degree (0=not true at all to 4=true nearly all the time) respondent can cope/be resilient in various situations. Higher score means more resilience. | Mean | Standard Deviation | units on a scale |
|
| Pain Self-Efficacy | The Pain Self-Efficacy Questionnaire, a 10-item scale (Nicholas 1989) rating confidence at doing specific things (e.g., chores, accomplishing goals, becoming more active) despite pain; each item scored from 0=not at all confident to 6=completely confident. | Mean | Standard Deviation | units on a scale |
|
| Pain intensity (0 to 10) | A numeric rating scale ranging from 0 (no pain at all; best outcome) to 10 (worst pain you can imagine; worst outcome) | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care Control Group | After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker. |
|
|
| Primary | Change in Self-reported Physical Functioning | The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome. | Participants who had both baseline and follow-up data on this measure. | Posted | Mean | Standard Deviation | T-score | Baseline and 8 weeks |
|
|
|
| Secondary | Participant Global Impression of Change--Pain | How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome. | Participants with baseline and follow-up data on this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Pain Self-efficacy | The Pain Self-Efficacy Questionnaire, a 10-item scale (Nicholas 1989) rating confidence at doing specific things (e.g., chores, accomplishing goals, becoming more active) despite pain; each item scored from 0=not at all confident to 6=completely confident. | Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, positive change value is a better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Social Participation | Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome. | Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value (or smaller positive change) is a better outcome. | Posted | Mean | Standard Deviation | T-score | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Resilience | 10-item version of the Connor-Davidson resilience scale rating the degree (0=not true at all to 4=true nearly all the time) respondent can cope/be resilient in various situations. Higher score means more resilience. | Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, positive change value is a better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Participant Global Impression of Change - Functioning | How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome. | Participants with baseline and follow-up data on this measure. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| 0 |
| 25 |
| EG001 | Usual Care Control Group | After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker. | 0 | 26 | 0 | 26 | 0 | 26 |
|
| hospitalization | Cardiac disorders | Non-systematic Assessment | Participant hospitalized with chest pain; determined to be unrelated to intervention. |
|
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|