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

NCT ID: NCT03285958

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2018-08-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

STEPS Intervention

Intervention Type: 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 Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Janevic

Assistant Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Janevic

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Public Health

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00133021

Identifier Type: -

Identifier Source: org_study_id