Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UH3
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: RAMP Program.
- Кому может быть актуально
- Состояния в реестре: Chronic 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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Официальное название
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
Обзор
The goal of the RAMP mind-body program is to provide Veterans with information and tools that can help them manage their pain. The program explores the important connection between our bodies and minds, and how to use this special connection to manage pain more effectively.
Подробное описание
Our long-term objective is to improve pain management and reduce opioid use among rural patients in the VA. To accomplish this, we will conduct a randomized clinical trial (RCT) to test the effectiveness of an innovative multi-component complementary and integrative intervention, Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP) delivered via group telehealth, for improving rural Veterans' pain management, function, and wellbeing, within the VA healthcare system. This project addresses the significant challenge of implementing effective, non-opioid interventions for chronic pain management among rural Veterans, who experience a disproportionate share of the national pain burden, with more chronicity, opioid harms, comorbid mental health conditions and substance abuse, and are prescribed more opioids and have less access to evidence-based, chronic pain care that addresses their "whole-person" or biopsychosocial needs. The RAMP program strategically coalesces multiple evidence based CIH self-management strategies to address rural Veterans' biopsychosocial needs and overcome existing barriers to implementation. Comprised of pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies, the program is cohesive and scalable.
Вмешательства
- Поведенческое RAMP Program
RAMP is a 9-week program comprised of weekly online group sessions (90 minutes each) with pre-recorded expert-led education videos, mind-body skill training and practice, and facilitated discussions.
Первичные конечные точки
- Pain interference [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
Вторичные конечные точки (12)
- Pain intensity [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Pain impact [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Quality of life [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Quality of life [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Physical functioning [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Sleep disturbance [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Sleep duration [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Fatigue [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Participation in Social Roles and Activities [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Anxiety [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Depression [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
- Post Traumatic Stress Disorder (PTSD) [Срок оценки: Average over 6 months of follow-up, with assessments at baseline, 10 weeks and 6 months.]
Критерии участия
Критерии включения
- 18 years of age or older
- rural-dwelling based on U.S. Health Services Research Administration Criteria
- chronic pain based on two qualifying pain diagnoses in their electronic health record (EHR) within the same diagnostic category, at least 90 days apart, during the previous 2 years
- self-reported pain on at least most days in the past 3 months
- Brief Pain Inventory Interference subscale score ≥ 4/10
- access to a device with internet
- willingness to engage in intervention-specific procedures (e.g., meet remotely online for sessions)
- an email address listed in the EHR.
Критерии исключения
- severe, poorly controlled psychiatric or substance use disorder (identified by chart review)
- active member of advisory panel for the study
- enrollment in another research study for pain
- enrollment in a similar study
- enrollment in a similar facilitated, multi-week, multi-modal complementary and integrative health program.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Minneapolis VAMC — Minneapolis
Идентификаторы
NCT: NCT07541599 · 4UH3NR020929-02