The Clinical Impact of Integrated Behavioral Health Techniques in Patients With Fibromyalgia: A Mayo Clinic-Lin Health Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire - Revised
研究概览
简要总结
The purpose of this research is to assess the impact of using Lin Health to provide virtual long-term follow up care for patients with a diagnosis of fibromyalgia.
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
- 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
- •Patient must be 18 years of age or older.
- •Patient must have a diagnosis of Fibromyalgia.
- •Patient must be being seen at the Mayo Clinic Fibromyalgia and Chronic Fatigue Clinic in Rochester, MN.
- •Patient must be able to understand and provide informed consent and HIPAA authorization
- •Patient must be willing and able to complete all aspects of the study.
- •Patient must be able to speak and read English.
排除标准
- •Patient who is under the age of 18 years old.
- •Patient who is unable to provide informed consent or HIPAA authorization.
- •Patient who declines study participation.
- •Patient who is unable to speak English.
- •Patient who is on active cancer therapy.
- •Patient who is actively psychotic or actively suicidal.
- •Patient who is deemed inappropriate to the study by the medical professional.
研究组 & 干预措施
Experimental Group
Subjects in the experimental group will receive Mayo Clinic's usual standard of care and Lin Health interventions.
干预措施: Longitudinal Behavioral Health Techniques (Behavioral)
Control Group
Subjects in control group will receive Mayo Clinic's usual standard of care.
干预措施: Standard of care treatment for Fibromyalgia (Behavioral)
结局指标
主要结局
Fibromyalgia Impact Questionnaire - Revised
时间窗: Baseline, 3 months
The Revised Fibromyalgia Impact Questionnaire (FIQR) is a self-report questionnaire designed to assess the impact of fibromyalgia on a patient's daily life. It evaluates function, overall impact, and symptoms experienced in the past 7 days. The FIQR uses an 11-point numeric scale (0 to 10) for each of the 21 questions, with higher scores indicating a greater impact of fibromyalgia.
次要结局
未报告次要终点
研究者
Elizabeth C. Wight
Principal Investigator
Mayo Clinic