Набор скоро начнётся NCT07456150

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

Фаза I С лечением Chronic Pain Musculoskeletal Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Coaching.
Кому может быть актуально: Состояния в реестре: Chronic Pain, Musculoskeletal Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Подробное описание

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.).

Вмешательства

Поведенческое Coaching
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).

Первичные конечные точки

Recruitment (number enrolled out of all eligible and asked to participate) [Срок оценки: Baseline]
Retention (number who complete intervention and outcomes at post-intervention out of all enrolled) [Срок оценки: 3 Months (primary) and 6 Months]

Вторичные конечные точки (4)

Feasibility of Intervention Measure (scale) [Срок оценки: 3 Months]
Acceptability of Intervention Measure (scale) [Срок оценки: 3 Months]
Intervention Appropriateness Measure (scale) [Срок оценки: 3 Months]
Pain intensity and interference [Срок оценки: Baseline, 3 Months, 6 Months]

Критерии участия

Критерии включения

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)