Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Pain interference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
干预措施: RAMP Program (Behavioral)
Usual Care
结局指标
主要结局
Pain interference
时间窗: Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.
Measured using the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.
次要结局
- Use of opioids(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Pain intensity(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Pain impact(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Quality of life(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Physical functioning(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Sleep disturbance(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Sleep duration(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Fatigue(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Participation in Social Roles and Activities(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Anxiety(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Depression(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Post Traumatic Stress Disorder (PTSD)(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Overall improvement(Average over 6 months of follow-up, with assessments at 3 and 6 months.)
- Substance use(Average over 6 months of follow-up, with assessments at baseline, 3 and 6 months.)
- Adverse events(Average over 6 months of follow-up, with assessments at 3 and 6 months.)
研究者
Diana J. Burgess
Principal Investigator
Minneapolis Veterans Affairs Medical Center