Chronic PainNCT03285958
Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit
A study testing STEPS Intervention in people with Chronic Pain, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- STEPS Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 14 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- >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
Who cannot join
- Serious acute illness or hospitalization in last month
- Planned surgery in next month
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies
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.
- Conditions
- Chronic Pain
- Being tested
- STEPS Intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPS InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: STEPS Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, eight weeks
Adherence to Step Count Reporting - SMS
Proportion of days that step count was successfully provided/possible reporting days for SMS
Measured: Two weeks
Adherence to Step Count Reporting - IVR
Proportion of days that step count was successfully provided/possible reporting days for IVR.
Measured: two weeks
Adherence to Step Count Reporting - Sync
Proportion of days that step count was successfully provided/possible reporting days for syncing with app
Measured: two weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start16 Nov 2017
- Primary completion20 Jul 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Janevic, University of Michigan
- Investigators
- Mary Janevic, Principal investigator, University of Michigan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285958
- Sponsor's protocol ID
- HUM00133021
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2017
- Last updated
- 4 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies
- ClinicalTrials.gov ID
- NCT03285958
- Acronym / sponsor ID
- HUM00133021
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 4 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS Intervention Group | Experimental | Behavioral: STEPS InterventionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (3 listed)
- Serious acute illness or hospitalization in last month
- Planned surgery in next month
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPS InterventionParticipants 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. | Behavioural | STEPS Intervention Group |
Primary outcome
Change in Pain Interference
Time frame: 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
Time frame: Two weeks
Proportion of days that step count was successfully provided/possible reporting days for SMS
Adherence to Step Count Reporting - IVR
Time frame: two weeks
Proportion of days that step count was successfully provided/possible reporting days for IVR.
Adherence to Step Count Reporting - Sync
Time frame: two weeks
Proportion of days that step count was successfully provided/possible reporting days for syncing with app
4 secondary outcomes
Change in Physical Functioning
Time frame: Baseline, eight weeks
Change in Social Participation
Time frame: Baseline, eight weeks
Validity of Manually-reported Step Count Data - SMS
Time frame: Two weeks
Validity of Manually Reported Step Count Data - IVR
Time frame: Two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Janevic principal investigator
University of Michigan School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS Intervention in people with Chronic Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Interference (time frame: Baseline, eight weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.