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Completed

NCT Number: NCT03285958

Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Adherence to Step Count Reporting - SMS

    Time frame: Two weeks

    Proportion of days that step count was successfully provided/possible reporting days for SMS

  3. Adherence to Step Count Reporting - IVR

    Time frame: two weeks

    Proportion of days that step count was successfully provided/possible reporting days for IVR.

  4. 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

Secondary outcomes

  1. Change in Physical Functioning

    Time frame: 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.

  2. Change in Social Participation

    Time frame: 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.

  3. Validity of Manually-reported Step Count Data - SMS

    Time frame: Two weeks

    Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

  4. Validity of Manually Reported Step Count Data - IVR

    Time frame: Two weeks

    Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2017
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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