ACTIVE_NOT_RECRUITING

STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine whether community health workers (CHWs)-i.e., lay health workers with close ties to the communities they serve - can effectively teach cognitive-behavioral pain management strategies to older adults in a disadvantaged urban setting. Specific aims are: to test, in a sample of 414 primarily African American older adults, whether the STEPS pain self-management intervention, delivered over 7 weeks through telephone sessions with a CHW and mobile health tools, improves pain outcomes at 2 and 12 months compared to a usual care control group. We will also assess the mechanisms by which the intervention may bring about positive changes in pain outcomes. We will use mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and factors affecting implementation.

Official Title

An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-Management Support for Vulnerable Older Adults

Quick Facts

Study Start:2022-11-29
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05278234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Community-living
  2. * Have a cell or landline phone
  3. * 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.
  4. * Able to converse comfortably in English
  1. * Serious acute illness or hospitalization in last month
  2. * Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement);
  3. * Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to participation

Contacts and Locations

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-29
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2022-11-29
Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain