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

NCT04095650 | Completed

• 2 other identifiers: HUM00154949K01AG050706
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Change in pain interference

  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)..

  baseline and 8 weeks

• Participant engagement

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

  8 weeks

Secondary Outcomes (2)

• Participant Global Impression of Change

  8 weeks

• Participant satisfaction: Likert-scale questions

  8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will engage in a 7-week chronic pain self-management program.

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator
• American Pain Society: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mary Janevic, PhD

  University of Michigan School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: September 20, 2019
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)