We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 2017 by Mary Janevic, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT03285958
First Posted: September 18, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mary Janevic, University of Michigan
  Purpose
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.

Condition Intervention
Chronic Pain Behavioral: STEPS Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies

Resource links provided by NLM:


Further study details as provided by Mary Janevic, University of Michigan:

Primary Outcome Measures:
  • Adherence to step count reporting [ Time Frame: Six weeks ]
    Proportion of days that step count was successfully provided/possible reporting days

  • Change in pain interference [ Time Frame: Baseline, six weeks ]
    Participants will be asked to rate their pain interference on the PROMIS-29, where a higher score indicates more pain interference.


Secondary Outcome Measures:
  • Change in physical functioning [ Time Frame: Baseline, six weeks ]
    Participants will be asked to rate their physical functioning on the PROMIS-29, where a higher score indicates more difficulty in functioning.

  • Participants will be asked to rate their participation in social roles on the PROMIS-29, where a higher score indicates more difficulty in participating. [ Time Frame: Baseline, six weeks ]
    from PROMIS-29

  • Validity of manually-reported step count data [ Time Frame: One week ]
    Correlation of manually-reported with automatically uploaded data - percentage of days that counts are within 50 steps of each other


Estimated Enrollment: 50
Actual Study Start Date: November 16, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STEPS Intervention Group
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
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.
No Intervention: STEPS Control Group
Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285958


Contacts
Contact: Mary Janevic, PhD 734 647 3194 mjanevic@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Mary Janevic University of Michigan School of Public Health
  More Information

Responsible Party: Mary Janevic, Assistant Research Scientist, University of Michigan
ClinicalTrials.gov Identifier: NCT03285958     History of Changes
Other Study ID Numbers: HUM00133021
First Submitted: September 14, 2017
First Posted: September 18, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms