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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: STEPS Intervention

• Registration Number: NCT03285958
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2017-11-16
• Primary Completion: 2018-07-20
• Study Completion: 2018-08-14
• Status Verified: 2021-09
• Results First Submitted: 2021-09-02
• Results First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Results First Posted: 2021-10-04
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEPS Intervention Group	STEPS Intervention	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.

Primary Outcome Measures

Name	Time	Method
Adherence to Step Count Reporting - SMS	Two weeks	Proportion of days that step count was successfully provided/possible reporting days for SMS
Change in Pain Interference	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	two weeks	Proportion of days that step count was successfully provided/possible reporting days for IVR.
Adherence to Step Count Reporting - Sync	two weeks	Proportion of days that step count was successfully provided/possible reporting days for syncing with app

Secondary Outcome Measures

Name	Time	Method
Change in Social Participation	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.
Validity of Manually-reported Step Count Data - SMS	Two weeks	Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Change in Physical Functioning	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.
Validity of Manually Reported Step Count Data - IVR	Two weeks	Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States