Chronic Pain
Conditions
Brief summary
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.
Interventions
BEHAVIORALSTEPS Intervention
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.
Sponsors
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
* Age \> 60 years * Ambulatory with or without assistive device * Community living * Have a SMS-capable cell phone * Internet access (via smartphone, in-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 * Ability to travel to study location in Detroit for a one-time session
Exclusion criteria
* Serious acute illness or hospitalization in last month * Planned surgery in next month * Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Step Count Reporting - Sync | two weeks | Proportion of days that step count was successfully provided/possible reporting days for syncing with app |
| Change in Pain Interference | Baseline, eight weeks | 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. |
| Adherence to Step Count Reporting - SMS | Two weeks | Proportion of days that step count was successfully provided/possible reporting days for SMS |
| Adherence to Step Count Reporting - IVR | two weeks | Proportion of days that step count was successfully provided/possible reporting days for IVR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Functioning | Baseline, eight 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. |
| Change in Social Participation | Baseline, eight 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. |
| Validity of Manually-reported Step Count Data - SMS | Two weeks | Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other |
| Validity of Manually Reported Step Count Data - IVR | Two weeks | Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other |
Countries
United States
Participant flow
Pre-assignment details
No significant pre-assignment events.
Participants by arm
| Arm | Count |
|---|---|
| STEPS Intervention Group 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.
STEPS Intervention: 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. | 28 |
| STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count. | 23 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Not able to attend required orientation | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | STEPS Control Group | Total | STEPS Intervention Group |
|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 6.4 | 70.4 years STANDARD_DEVIATION 6.8 | 71.3 years STANDARD_DEVIATION 7.1 |
| Pain intensity in last week | 5.4 units on a scale STANDARD_DEVIATION 2.2 | 5.2 units on a scale STANDARD_DEVIATION 1.8 | 5.1 units on a scale STANDARD_DEVIATION 1.3 |
| PROMIS 4-item pain interference T-score | 57.0 units on a scale STANDARD_DEVIATION 8.4 | 58.0 units on a scale STANDARD_DEVIATION 7.2 | 58.7 units on a scale STANDARD_DEVIATION 6.1 |
| PROMIS 4-item physical function difficulty T-score | 31.9 units on a scale STANDARD_DEVIATION 4.2 | 33.0 units on a scale STANDARD_DEVIATION 5.2 | 33.2 units on a scale STANDARD_DEVIATION 4.3 |
| PROMIS 4-item social partcipation T-score | 37.0 units on a scale STANDARD_DEVIATION 6.4 | 37.6 units on a scale STANDARD_DEVIATION 6.9 | 38.1 units on a scale STANDARD_DEVIATION 7.3 |
| 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 | 21 Participants | 48 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 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 | 23 participants | 51 participants | 28 participants |
| Sex: Female, Male Female | 19 Participants | 45 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 23 |
| other Total, other adverse events | 0 / 28 | 0 / 23 |
| serious Total, serious adverse events | 1 / 28 | 0 / 23 |
Outcome results
Primary
Adherence to Step Count Reporting - IVR
Proportion of days that step count was successfully provided/possible reporting days for IVR.
Time frame: two weeks
Population: Intervention group participants with baseline and follow-up data. Excludes one case who did not receive IVR calls on schedule due to system error. Result represents number of adherent person-days out of all possible person-days for IVR.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| STEPS Intervention Group | Adherence to Step Count Reporting - IVR | 257 person-days |
Primary
Adherence to Step Count Reporting - SMS
Proportion of days that step count was successfully provided/possible reporting days for SMS
Time frame: Two weeks
Population: Intervention group participants with baseline and follow-up data. Excludes one case that did not have a texting plan on her phone. Result represents number of adherent person-days out of all possible person-days for SMS.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| STEPS Intervention Group | Adherence to Step Count Reporting - SMS | 299 person-days |
Primary
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
Population: Intervention group participants with baseline and follow-up data. Result represents number of adherent person-days out of all possible person-days for sync.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| STEPS Intervention Group | Adherence to Step Count Reporting - Sync | 267 person-days |
Primary
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
Population: This is from the analytic sample that had both baseline and follow-up data on this 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 |
|---|---|---|---|
| STEPS Intervention Group | Change in Pain Interference | -0.85 score on a scale | Standard Deviation 6.2 |
| STEPS Control Group | Change in Pain Interference | -0.21 score on a scale | Standard Deviation 6.6 |
Secondary
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
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 |
|---|---|---|---|
| STEPS Intervention Group | Change in Physical Functioning | -1.4 units on a scale (T-score) | Standard Deviation 3.5 |
| STEPS Control Group | Change in Physical Functioning | -0.85 units on a scale (T-score) | Standard Deviation 3.7 |
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, eight 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 value) is a better outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| STEPS Intervention Group | Change in Social Participation | 0.28 units on a scale | Standard Deviation 7.8 |
| STEPS Control Group | Change in Social Participation | 0.83 units on a scale | Standard Deviation 8.4 |
Secondary
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
Population: Result is number of person- days with valid data reported that were within 50 steps of sync value.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| STEPS Intervention Group | Validity of Manually Reported Step Count Data - IVR | 94 person-days |
Secondary
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
Population: Result is number of person- days with valid data reported that were within 50 steps of sync value.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| STEPS Intervention Group | Validity of Manually-reported Step Count Data - SMS | 133 person-days |