An interventional study of STEPS Intervention in Chronic Pain, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-10-04.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
Wearable, commercially-available physical activity monitors are being increasingly incorporated into chronic pain self-management interventions as a tool to help patients set goals and to tailor intervention content based on patient progress. Yet older adults from resource-challenged communities may face significant barriers to using these monitors and reporting activity data. Our pilot study will focus on wearable monitor use among older adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of various technology-based strategies for reporting daily step count data. The study will also assess whether six weeks of monitor use is associated with improvements in functioning, relative to a control group.
Exclusion criteria:
Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.
Behavioral: STEPS Intervention
Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.
Change in Pain Interference
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. 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 scores are 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, eight weeks
Adherence to Step Count Reporting - SMS
Proportion of days that step count was successfully provided/possible reporting days for SMS
Time frame: Two weeks
Adherence to Step Count Reporting - IVR
Proportion of days that step count was successfully provided/possible reporting days for IVR.
Time frame: two weeks
Adherence to Step Count Reporting - Sync
Proportion of days that step count was successfully provided/possible reporting days for syncing with app
Time frame: two weeks
Change in 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, eight 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.
Time frame: Baseline, eight weeks
Validity of Manually-reported Step Count Data - SMS
Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Time frame: Two weeks
Validity of Manually Reported Step Count Data - IVR
Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Time frame: Two weeks
| Milestone | STEPS Intervention Group | STEPS Control Group |
|---|---|---|
| Started | 33 | 24 |
| Completed | 28 | 23 |
| Not completed | 5 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Not able to attend required orientation | 3 | 0 |
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. 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 scores are 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.
| score on a scale | STEPS Intervention Group | STEPS Control Group |
|---|---|---|
| Change in Pain Interference | -0.85 ± 6.2 | -0.21 ± 6.6 |
Proportion of days that step count was successfully provided/possible reporting days for SMS
| person-days | STEPS Intervention Group |
|---|---|
| Adherence to Step Count Reporting - SMS | 299 |
Proportion of days that step count was successfully provided/possible reporting days for IVR.
| person-days | STEPS Intervention Group |
|---|---|
| Adherence to Step Count Reporting - IVR | 257 |
Proportion of days that step count was successfully provided/possible reporting days for syncing with app
| person-days | STEPS Intervention Group |
|---|---|
| Adherence to Step Count Reporting - Sync | 267 |
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.
| units on a scale (T-score) | STEPS Intervention Group | STEPS Control Group |
|---|---|---|
| Change in Physical Functioning | -1.4 ± 3.5 | -0.85 ± 3.7 |
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.
| units on a scale | STEPS Intervention Group | STEPS Control Group |
|---|---|---|
| Change in Social Participation | 0.28 ± 7.8 | 0.83 ± 8.4 |
Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
| person-days | STEPS Intervention Group |
|---|---|
| Validity of Manually-reported Step Count Data - SMS | 133 |
Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
| person-days | STEPS Intervention Group |
|---|---|
| Validity of Manually Reported Step Count Data - IVR | 94 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| STEPS Intervention Group | 0/28 (0%) | 1/28 (3.6%) | 0/28 (0%) |
| STEPS Control Group | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Event | STEPS Intervention Group | STEPS Control Group |
|---|---|---|
| hospitalizationRespiratory, thoracic and mediastinal disorders | 1/28 | 0/23 |
Note: This is the analytic sample (i.e., participants with baseline and 8-week follow-up data, representing 51 of 57 randomized.)
| Age, Continuous(years) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| Mean | 71.3 ± 7.1 | 69.3 ± 6.4 | 70.4 ± 6.8 |
| Sex: Female, Male(Participants) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| Female | 26 | 19 | 45 |
| Male | 2 | 4 | 6 |
| Race (NIH/OMB)(Participants) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 21 | 48 |
| White | 0 | 0 | 0 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| United States | 28 | 23 | 51 |
| Pain intensity in last week(units on a scale) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| Mean | 5.1 ± 1.3 | 5.4 ± 2.2 | 5.2 ± 1.8 |
| PROMIS 4-item pain interference T-score(units on a scale) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| Mean | 58.7 ± 6.1 | 57.0 ± 8.4 | 58.0 ± 7.2 |
| PROMIS 4-item physical function difficulty T-score(units on a scale) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| Mean | 33.2 ± 4.3 | 31.9 ± 4.2 | 33.0 ± 5.2 |
| PROMIS 4-item social partcipation T-score(units on a scale) | STEPS Intervention Group | STEPS Control Group | Total |
|---|---|---|---|
| Mean | 38.1 ± 7.3 | 37.0 ± 6.4 | 37.6 ± 6.9 |
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