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Clinical Trials/NCT04095650
NCT04095650
Completed
Not Applicable

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

University of Michigan1 site in 1 country38 target enrollmentSeptember 20, 2019
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Michigan
Enrollment
38
Locations
1
Primary Endpoint
Change in pain interference
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2019
End Date
May 14, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Janevic

Assistant Research Scientist

University of Michigan

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)..

Participant engagement

Time Frame: 8 weeks

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

Secondary Outcomes

  • Participant Global Impression of Change(8 weeks)
  • Participant satisfaction: Likert-scale questions(8 weeks)

Study Sites (1)

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