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Completed

NCT Number: NCT04095650

A New Model to Reach Vulnerable Older Adults With Pain Self-management Support

Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-proficient
  • Age >= 60 years
  • Ambulatory with or without assistive device
  • Community-living
  • Have a cell or landline phone
  • Have Internet access (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 attend a one-time study orientation session

Exclusion criteria

  • Serious acute illness or hospitalization in last month
  • Planned surgery in next three months
  • Significant cognitive impairment as indicated by affirmative response to question: "Do you have significant difficulties with your memory that get in the way of your usual daily activities?"
  • Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.

Treatment and study plan

STEPS (Seniors using Technology to Engage in Pain Self-management)

Behavioral

Participants will meet with a community health worker (CHW) at a one-hour in-person study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and associated materials, and schedule six weekly telephone sessions with the CHW. Participants will be given a wearable physical activity tracker to use throughout the course of the program. They can choose to report daily step counts by automatically syncing to an app or via text message. Each week during the study period, participants will engage with content on the website, have a session with the community health worker, track their daily steps, and set and work toward pain-management goals.

Primary outcomes

  1. Change in pain interference

    Time frame: baseline and 8 weeks

    The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. 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 total scale scores range from 6 (low interference) to 30 (high interference)..

  2. Participant engagement

    Time frame: 8 weeks

    Number of completed sessions with the community health worker (range 1 to 7).

Secondary outcomes

  1. Participant Global Impression of Change

    Time frame: 8 weeks

    Two items: 1) How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). 2) How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).

  2. Participant satisfaction: Likert-scale questions

    Time frame: 8 weeks

    Likert-scale questions about participant satisfaction with the program; e.g., whether participation increased understanding of pain management (Strongly Agree=1 to Strongly Disagree=5), and with selected program elements (e.g., community health workers, videos, website).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Pain Society
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2019
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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