Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:42 AM
Study NCT ID:
NCT07456150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 25-2658 | OTHER_GRANT | COMIRB | View |