Chronic Pain
Conditions
Brief summary
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.
Interventions
BEHAVIORALPositive 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 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.
Sponsors
National Institute on Aging (NIA)
Weill Medical College of Cornell University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English-proficient * Ambulatory with or without assistive device * Community-living * Have a cell or landline phone * Have Internet access (home or elsewhere); * Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities.
Exclusion criteria
* Serious acute illness or hospitalization in last month * Planned surgery in next three months * Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | Baseline and 8 weeks | 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. |
| Change in Self-reported Physical Functioning | Baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Participation | Baseline and 8 weeks | 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. |
| Participant Global Impression of Change--Pain | Baseline and 8 weeks | How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome. |
| Participant Global Impression of Change - Functioning | 8 weeks | How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome. |
| Change in Resilience | Baseline and 8 weeks | 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. |
| Change in Pain Self-efficacy | Baseline and 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 26 |
| Total | 51 |
Baseline characteristics
| Characteristic | Total | Usual Care Control Group | Intervention Group |
|---|---|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 7.2 | 71.9 years STANDARD_DEVIATION 7.6 | 71.6 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 25 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Pain intensity (0 to 10) | 6.4 units on a scale STANDARD_DEVIATION 1.7 | 6.4 units on a scale STANDARD_DEVIATION 1.5 | 6.3 units on a scale STANDARD_DEVIATION 1.9 |
| Pain interference (PROMIS 6-item scale) | 59.4 T-score STANDARD_DEVIATION 7.3 | 59.1 T-score STANDARD_DEVIATION 7.9 | 59.8 T-score STANDARD_DEVIATION 6.6 |
| Pain Self-Efficacy | 4.5 units on a scale STANDARD_DEVIATION 1.3 | 4.4 units on a scale STANDARD_DEVIATION 1.3 | 4.7 units on a scale STANDARD_DEVIATION 1.3 |
| Physical functioning (PROMIS 4-item scale) | 40.9 T-score STANDARD_DEVIATION 6.7 | 40.8 T-score STANDARD_DEVIATION 6.4 | 41.1 T-score STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 24 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 51 participants | 26 participants | 25 participants |
| Resilience (Connor-Davidson 10-item scale) | 3.2 units on a scale STANDARD_DEVIATION 0.52 | 3.3 units on a scale STANDARD_DEVIATION 0.49 | 3.1 units on a scale STANDARD_DEVIATION 0.56 |
| Sex: Female, Male Female | 46 Participants | 23 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 2 Participants |
| Social participation (PROMIS 4-item scale) | 48.8 T-score STANDARD_DEVIATION 9.1 | 48.2 T-score STANDARD_DEVIATION 8.9 | 49.4 T-score STANDARD_DEVIATION 9.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 2 / 25 | 0 / 26 |
Outcome results
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.
Time frame: Baseline and 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Pain Interference | -3.82 T-score | Standard Deviation 5.2 |
| Usual Care Control Group | Change in Pain Interference | .32 T-score | Standard Deviation 5 |
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.
Time frame: Baseline and 8 weeks
Population: Participants who had both baseline and follow-up data on this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Self-reported Physical Functioning | 43.7 T-score | Standard Deviation 7.7 |
| Usual Care Control Group | Change in Self-reported Physical Functioning | 40.9 T-score | Standard Deviation 6.3 |
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.
Time frame: Baseline and 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Pain Self-efficacy | .36 units on a scale | Standard Deviation 0.91 |
| Usual Care Control Group | Change in Pain Self-efficacy | -.16 units on a scale | Standard Deviation 0.71 |
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.
Time frame: Baseline and 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Resilience | .10 units on a scale | Standard Deviation 0.38 |
| Usual Care Control Group | Change in Resilience | -.02 units on a scale | Standard Deviation 0.44 |
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.
Time frame: Baseline and 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Social Participation | .11 T-score | Standard Deviation 4.4 |
| Usual Care Control Group | Change in Social Participation | .17 T-score | Standard Deviation 3.3 |
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.
Time frame: 8 weeks
Population: Participants with baseline and follow-up data on this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Participant Global Impression of Change - Functioning | 6.4 units on a scale | Standard Deviation 0.74 |
| Usual Care Control Group | Participant Global Impression of Change - Functioning | 4.6 units on a scale | Standard Deviation 1.4 |
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.
Time frame: Baseline and 8 weeks
Population: Participants with baseline and follow-up data on this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Participant Global Impression of Change--Pain | 6.1 units on a scale | Standard Deviation 0.97 |
| Usual Care Control Group | Participant Global Impression of Change--Pain | 4.4 units on a scale | Standard Deviation 1.3 |