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NCT Number: NCT07456150

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location contact

Michelle R Rauzi, DPT

CONTACT

[email protected]

208-630-4002

Michelle R Rauzi, DPT

PRINCIPAL_INVESTIGATOR

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: 3 Months (primary) and 6 Months

    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)

Secondary outcomes

  1. Feasibility of Intervention Measure (scale)

    Time frame: 3 Months

    The Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater feasibility of the program. Feasibility will be evaluated post-program (anticipated 3 months).

  2. Acceptability of Intervention Measure (scale)

    Time frame: 3 Months

    The Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater acceptability of the program. Feasibility will be evaluated post-program (anticipated 3 months).

  3. Intervention Appropriateness Measure (scale)

    Time frame: 3 Months

    The Intervention Appropriateness Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater appropriateness of the program. Feasibility will be evaluated post-program (anticipated 3 months).

  4. Pain intensity and interference

    Time frame: Baseline, 3 Months, 6 Months

    Pain intensity and interference will be measured by the PEG-3 (Pain intensity, interference with Enjoyment of life, and interference with General activity) scale. The PEG-3 is a 3-item measure that is valid for individuals with chronic pain and is sensitive to change. Mean of the three individual item scores are reported and can range from 0 to 10. Lower scores indicated less pain intensity and interference.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph W Frank, MD MPH

CONTACT

[email protected]

(720) 857-2784

Michelle R Rauzi, DPT

CONTACT

[email protected]

(208) 630-4002

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2029
Primary completion
2030
Study completion
2031
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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