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

NCT ID: NCT04095650

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2020-05-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

STEPS (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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

American Pain Society

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Janevic

Assistant Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Janevic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Public Health

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

K01AG050706

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00154949

Identifier Type: -

Identifier Source: org_study_id