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
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participants Recruited
研究概览
简要总结
This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3), the investigators will conduct a single-arm pilot study of 40 rural VA patients with chronic pain to assess study feasibility (recruitment and retention), intervention feasibility (fidelity of intervention delivery and participant engagement rates), acceptability, and effectiveness at addressing pre-defined capabilities, opportunities and motivations.
详细描述
Pain is a complex biophysical, psychological, and social condition and there is a growing evidence base to support several complementary and integrative health (CIH) approaches, which can address pain in a more holistic way. While the VA has become a leader in advancing CIH through its Whole Health Initiative, there remain many barriers, especially for rural patients. This pilot study will assess the feasibility of an innovative telehealth evidence-based intervention for rural VA patients with chronic pain: the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP was developed with multiple-levels of VA stakeholders (including rural patients). It was designed to deliver multiple CIH self-management strategies (pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies) in one intervention, to overcome existing barriers to care and improve rural Veterans' pain and important biopsychosocial outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Veteran participants must be rural dwelling
- •Patient's Veterans Affairs (VA) primary care provider is in the Southeast region of the US
- •Email address in the VA electronic health record (EHR)
- •Report pain at least most days in the past 3 months
- •Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater
- •Willingness and ability to complete study activities including meeting remotely via videoconferencing when program sessions are held
排除标准
- •Participation in a prior project conducted by the study team on mindfulness for pain (NCT0456158) or an engagement activities advisor for the current project
- •Current enrollment in a research study for pain
- •Current enrollment in a similar facilitated, multi-week, multi-modal CIH program
- •Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)
研究组 & 干预措施
Intervention
干预措施: RAMP program (Behavioral)
结局指标
主要结局
Participants Recruited
时间窗: 3 months
Number of participants recruited
Female Participants Recruited
时间窗: 3 months
Percentage of Female Participants Recruited
Racial/Ethnic Minoritized Participants Recruited
时间窗: 3 months
Percentage of Racial/Ethnic Minoritized Participants Recruited
Participant Satisfaction
时间窗: 3 months
Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale
Participant Engagement
时间窗: 3 months
Percentage of participants who participated in at least 7 out of 12 sessions either by attending the group session (i.e., synchronous participation) or reporting that they completed any of the session activities on their own (i.e., asynchronous participation)
Fidelity of Intervention Delivery
时间窗: 3 months
Two experts in developing and delivering mind-body interventions for pain independently observed 10% of sessions via videoconference using a structured checklist.
Survey Response Rate
时间窗: 3 month
Percentage of participants completing post-treatment data collection
次要结局
未报告次要终点
研究者
Diana J. Burgess
Core Investigator
Minneapolis Veterans Affairs Medical Center