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

NCT07456150 | Not Yet Recruiting Phase 1

• 2 other identifiers: RRD9-011-25M25-2658
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

Veterans; Human-centered Design; Coaching; Self Care

Outcome Measures

Primary Outcomes (2)

• Recruitment (number enrolled out of all eligible and asked to participate)

  Recruitment rate is defined as the proportion of Veterans who enroll in the feasibility study out of all those eligible who were asked to participate.

  Baseline

• Retention (number who complete intervention and outcomes at post-intervention out of all enrolled)

  Retention is defined as the proportion of Veterans who complete the intervention (anticipated timeframe of 3 months) and the proportion who complete the post-intervention outcomes (anticipated 3 months) and follow-up outcomes (anticipated 6 months)

  3 Months (primary) and 6 Months

Secondary Outcomes (4)

• Feasibility of Intervention Measure (scale)

  3 Months

• Acceptability of Intervention Measure (scale)

  3 Months

• Intervention Appropriateness Measure (scale)

  3 Months

• Pain intensity and interference

  Baseline, 3 Months, 6 Months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized to the Intervention arm will receive the intervention for developing and maintaining a personalized pain self-care plan. The intervention is anticipated to be a coaching program that will last for about 3 months; specific details of the intervention will be updated prior to enrollment.

Behavioral: Coaching

Control

NO INTERVENTION

Participants randomized to the Control arm will receive advise to continue with their planned medical care and daily activities. Specific details and the type of comparator arm will be updated prior to enrollment because these may changed based on key partner findings in stages 1 and 2 (aims 1 and 2).

Interventions

Coaching BEHAVIORAL

The 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).

Intervention

Eligibility Criteria

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

You may qualify if:

• U.S. military Veteran
• Chronic musculoskeletal pain defined by the National Health Interview Survey (pain that has been present on most days for the past 3 months)

You may not qualify if:

• Moderate to Severe cognitive impairment
• Severe or untreated substance use disorder
• Severe or untreated mental health condition
• Enrolled in hospice or palliative care with life expectancy \<12 months

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Michelle R Rauzi, DPT

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle R Rauzi, DPT

CONTACT

(208) 630-4002; michelle.rauzi@va.gov

Joseph W Frank, MD MPH

CONTACT

(720) 857-2784; joseph.frank2@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the Intervention or Control Group using computer-generated random blocks, stratified by sex.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start (Estimated): January 1, 2029
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)