Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEPS Intervention Group | Experimental | 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 Control Group | No Intervention | Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STEPS Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, eight weeks |
| Adherence to Step Count Reporting - SMS | Proportion of days that step count was successfully provided/possible reporting days for SMS | Two weeks |
| Adherence to Step Count Reporting - IVR | Proportion of days that step count was successfully provided/possible reporting days for IVR. | two weeks |
| Adherence to Step Count Reporting - Sync | Proportion of days that step count was successfully provided/possible reporting days for syncing with app | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Janevic | University of Michigan School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
No significant pre-assignment events.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Note: This is the analytic sample (i.e., participants with baseline and 8-week follow-up data, representing 51 of 57 randomized.)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, eight weeks |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant was hospitalized for pneumonia. Not related to research. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Janevic | University of Michigan | 734 647 3194 | mjanevic@umich.edu |
Not provided
| 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 | Jun 19, 2018 | Aug 31, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2018 | Aug 31, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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 | 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 | Two weeks |
| Not able to attend required orientation |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain intensity in last week | Pain intensity rated on 1 to 10 scale, where 1=no pain and 10=worst imaginable pain). | Mean | Standard Deviation | units on a scale |
|
| PROMIS 4-item pain interference T-score | 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). Converted to population-normed T-score (population mean of 50). | Mean | Standard Deviation | units on a scale |
|
| PROMIS 4-item physical function difficulty T-score | 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). Converted to population-normed T-score (population mean of 50). | Mean | Standard Deviation | units on a scale |
|
| PROMIS 4-item social partcipation T-score | Items assess difficulty participating in family activities, leisure activities, and work 1=not at all to 5=very much). Converted to population-normed T-score (population mean of 50). | Mean | Standard Deviation | units on a scale |
|
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.
| OG001 | 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. |
|
|
| Primary | Adherence to Step Count Reporting - SMS | Proportion of days that step count was successfully provided/possible reporting days for SMS | 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. | Posted | Count of Units | person-days | Two weeks | person-days | person-days |
|
|
|
| Primary | Adherence to Step Count Reporting - IVR | Proportion of days that step count was successfully provided/possible reporting days for IVR. | 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. | Posted | Count of Units | person-days | two weeks | person-days | 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 | Intervention group participants with baseline and follow-up data. Result represents number of adherent person-days out of all possible person-days for sync. | Posted | Count of Units | person-days | two weeks | person-days | person-days |
|
|
|
| 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. | 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 | units on a scale (T-score) | Baseline, eight 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 value) is a better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, eight weeks |
|
|
|
| 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 | Result is number of person- days with valid data reported that were within 50 steps of sync value. | Posted | Count of Units | person-days | Two weeks | person-days | person-days |
|
|
|
| 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 | Result is number of person- days with valid data reported that were within 50 steps of sync value. | Posted | Count of Units | person-days | Two weeks | person-days | person-days |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
|
Not provided
Not provided
Not provided