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Clinical Trials/NCT03285958
NCT03285958CompletedNot Applicable

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

University of Michigan1 site in 1 country57 target enrollmentStarted: November 16, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
1
Primary Endpoint
Adherence to Step Count Reporting - SMS

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: STEPS Intervention (Behavioral)

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.

Outcomes

Primary Outcomes

Adherence to Step Count Reporting - SMS

Time Frame: Two weeks

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

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 - 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

Secondary Outcomes

  • Change in Social Participation(Baseline, eight weeks)
  • Validity of Manually-reported Step Count Data - SMS(Two weeks)
  • Change in Physical Functioning(Baseline, eight weeks)
  • Validity of Manually Reported Step Count Data - IVR(Two weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary Janevic

Assistant Research Scientist

University of Michigan

Study Sites (1)

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