Emerging Tick-borne Diseases in Children and Adults in Sweden (SWEtick): a Prospective Multicenter Study for Improved Patient Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- EuroQoL-5 Dimension Questionnaire (EQ-5D)
研究概览
简要总结
The purpose of the SWEtick project is to increase the knowledge of the various clinical presentations of emerging tick-borne diseases (eTBD), to assess their importance for human health, to develop and validate laboratory methods for diagnosis of eTBD, and to develop recommendations for knowledge-driven management of patients with suspected eTBD within the Swedish healthcare system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in TBD and Non-TBD groups:
- •Clinical suspicion of tick-borne disease (physician's assessment based on medical history, symptoms, clinical findings and sometimes laboratory results)
排除标准
- •Incapacitated to understand the study information and make decisions (adults and adolescents >15 years)
研究组 & 干预措施
Non-TBD
Patients investigated for suspected tick-borne disease but diagnosed with another condition (tick-borne disease excluded)
Control group CNS
Patients obtaining spinal anasthesia in conjunction with knee or hip replacement surgery due to arthrosis
Control group arthritis
Patients with autoinflammatory joint disease
Control group healthy
Blood donors
TBD
Patients with confirmed tick-borne disease
结局指标
主要结局
EuroQoL-5 Dimension Questionnaire (EQ-5D)
时间窗: 6 months
Difference in EQ-5D Health index between study inclusion and at the 6 month-follow-up
Visual Analogue Scale for Health (VAS)
时间窗: 6 months
Difference between the VAS units at study inclusion and at 6 month-follow-up.
次要结局
未报告次要终点
研究者
Anna J Henningsson
Senior Consultant, Senior Associate Professor
Region Jönköping County