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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPS Intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STEPS Intervention Group

STEPS Control Group

Arm Description

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.

Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.

Outcomes

Primary Outcome Measures

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.
Adherence to Step Count Reporting - SMS
Proportion of days that step count was successfully provided/possible reporting days for SMS
Adherence to Step Count Reporting - IVR
Proportion of days that step count was successfully provided/possible reporting days for IVR.
Adherence to Step Count Reporting - Sync
Proportion of days that step count was successfully provided/possible reporting days for syncing with app

Secondary Outcome Measures

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.
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.
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
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

Full Information

First Posted
September 14, 2017
Last Updated
September 2, 2021
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03285958
Brief Title
Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit
Official Title
Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEPS Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
STEPS Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Intervention Type
Behavioral
Intervention Name(s)
STEPS Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in Pain Interference
Description
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.
Time Frame
Baseline, eight weeks
Title
Adherence to Step Count Reporting - SMS
Description
Proportion of days that step count was successfully provided/possible reporting days for SMS
Time Frame
Two weeks
Title
Adherence to Step Count Reporting - IVR
Description
Proportion of days that step count was successfully provided/possible reporting days for IVR.
Time Frame
two weeks
Title
Adherence to Step Count Reporting - Sync
Description
Proportion of days that step count was successfully provided/possible reporting days for syncing with app
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Change in Physical Functioning
Description
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.
Time Frame
Baseline, eight weeks
Title
Change in Social Participation
Description
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.
Time Frame
Baseline, eight weeks
Title
Validity of Manually-reported Step Count Data - SMS
Description
Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Time Frame
Two weeks
Title
Validity of Manually Reported Step Count Data - IVR
Description
Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Janevic
Organizational Affiliation
University of Michigan School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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