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

NCT03285958 | Completed Results

• 1 other identifier: HUM00133021
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Change in Physical Functioning

  Baseline, eight weeks

• Change in Social Participation

  Baseline, eight weeks

• Validity of Manually-reported Step Count Data - SMS

  Two weeks

• Validity of Manually Reported Step Count Data - IVR

  Two weeks

Study Arms (2)

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.

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.

Interventions

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.

STEPS Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious acute illness or hospitalization in last month
• Planned surgery in next month
• Severe cognitive impairment

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Mary Janevic
• Organization: University of Michigan

mjanevic@umich.edu

734 647 3194

Study Officials

• Mary Janevic

  University of Michigan School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: November 16, 2017
• Primary Completion: July 20, 2018
• Study Completion: August 14, 2018
• Last Updated: October 4, 2021
• Results First Posted: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)