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Not Yet RecruitingNCT07456150

Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Half of all Veterans who seek care from the Veterans Health Administration (VHA) experience chronic musculoskeletal pain. First-line treatment for chronic pain should include nonpharmacological interventions. Although Veterans have access to these interventions, there is no standardized process to personalize them to meet the needs of individual Veterans despite the fact that personalization and self-care are key components of the VHA's Stepped Care Model for pain management. This proposal seeks to adapt and evaluate a coaching intervention that will be a personalized approach to help Veterans develop and maintain pain self-care plans. The proposed research responds to VHA's strategic objectives to tailor service delivery (obj. 2.2) and develop or adapt interventions that improve Veteran outcomes (obj. 2.4).

Detailed description

The overall purpose of this research is to design and test an intervention that will support Veterans in developing and maintaining a self-care plan for chronic pain. This study will use a multi-stage mixed methods intervention development and optimization design. The first stage (Aim 1) is a convergent mixed methods design that incorporates traditional qualitative, human-centered design, and quantitative methods to discover Veteran and clinician preferences and recommendations for an intervention to support personalization and maintenance of pain self-care plans. The second stage (Aim 2) uses human-centered design methods to engage with multiple key partners (Veterans, clinicians, leadership, etc.) to iterative design the intervention. The final stage (Aim 3) is a convergent mixed-methods design that will test the intervention among Veterans with chronic pain. Aim 3 will evaluate the feasibility and acceptability of the intervention using a randomized feasibility study with 2 parallel arms (n=15/arm). The primary feasibility outcomes are recruitment and retention; secondary outcomes will evaluate willingness of participants to be randomized, acceptability of the intervention, and changes in Veteran-level outcomes (pain interference, quality of life, etc.).

Conditions

Interventions

TypeNameDescription
BEHAVIORALCoachingThe intervention will likely incorporate health coaching to support participants in developing and maintaining their pain self-care plans. Details of the intervention will be updated prior to enrollment because the core components may changed based on findings from stages 1 and 2 (aims 1 and 2).

Timeline

Start date
2029-01-01
Primary completion
2030-06-30
Completion
2031-06-30
First posted
2026-03-06
Last updated
2026-03-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07456150. Inclusion in this directory is not an endorsement.