Phase II: GEMINI: Virtual Integrative Medical Group Visits for Managing Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Reduced pain impact (based on PROMIS 29)
研究概览
简要总结
The goal of this research study is to test the efficacy of a non-prescription medicine, web-based platform solution for patients with chronic pain, to improve pain self-management and related outcomes. The main question investigators aim to answer is; would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact?
详细描述
This study has 6 mandatory components and 1 optional component:
- Recruitment Screening Call
- Informed Consent Session
- Baseline Survey Session
- Intervention: Engagement with the Our Whole Lives (OWL) an e-health platform: For 9 weeks, participants will all have access to a mindfulness program within OWL, optimized for people with chronic pain.
- Live-Online Mindfulness Group weekly
- Control: Low dose engagement with OWL with no group engagement.
- Follow-Up Survey Sessions at Week 10, Week 16, and Week 24.
- Online Focus Group/Individual Interview. Participants will be asked to participate in an OPTIONAL individual interview, or a one-hour focus group with other participants in the study who used the OWL website as well.
Researchers will compare two groups that will be using the web-based platform. Each group will have different engagement content from the web-based platform and investigators will see if it affects overall chronic pain and pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, 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
- •English-speaking adults
- •Over the age of 18
- •Experiencing chronic musculoskeletal pain. (Pain may have more than one source; Pain must be non-malignant; Participant must have an average pain intensity of ≥ 4 (1 out of 10) in the past 7 days; Participant must meet the chronic criteria of a pain problem that has persisted at least 3 months, and has resulted in pain on at least half the days in the past 6 months)
排除标准
- •Inability to understand English at a level necessary for informed consent and understanding participation instructions, and participating in the group;
- •Serious underlying systemic or co-morbid conditions or life event that precludes physical or cognitive ability to participate in the study.
- •Severe depression
- •Current mania or psychosis;
- •Active heroin or cocaine use in the past 3 months
- •Heavy alcohol use
- •Known or planned pregnancy
结局指标
主要结局
Reduced pain impact (based on PROMIS 29)
时间窗: up to 24 weeks
The primary trial aim is to reduce pain impact.
次要结局
- Timeline Follow-Back (TLFB)(up to 24 weeks)
- The Patient-Reported Outcomes Measurement Information System (PROMIS 29)(up to 24 weeks)
- Pain Self- Efficacy Scale (PSEQ)(up to 24 weeks)