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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04095650
Enrollment
38
Registered
2019-09-19
Start date
2019-09-20
Completion date
2020-05-14
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

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

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
American Pain Society
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in pain interferencebaseline and 8 weeksThe 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 engagement8 weeksNumber of completed sessions with the community health worker (range 1 to 7).

Secondary

MeasureTime frameDescription
Participant Global Impression of Change8 weeksTwo 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)).
Participant satisfaction: Likert-scale questions8 weeksLikert-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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026