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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285958
• Other study ID #: HUM00133021
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: August 14, 2018

Study information

• Verified date: September 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 14, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• STEPS Intervention
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adherence to Step Count Reporting - SMS	Proportion of days that step count was successfully provided/possible reporting days for SMS	Two weeks
Primary	Adherence to Step Count Reporting - IVR	Proportion of days that step count was successfully provided/possible reporting days for IVR.	two weeks
Primary	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	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.	Baseline, eight weeks
Secondary	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.	Baseline, eight weeks
Secondary	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	Two weeks
Secondary	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	Two weeks