RSV Burden in Older Adults in Primary Care in The Netherlands: the RAPID Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Burden of medically attended RSV infection in the Dutch primary care
研究概览
简要总结
RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adults
With this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting.
详细描述
Th RAPID study is a prospective, observational study in Dutch primary care practices during two RSV seasons. As part of routine care, rapid molecular viral diagnostic testing on respiratory samples will be offered to all older adults attending the primary care physician because of symptoms of acute respiratory tract infection (ARTI). RSV positive cases will be included for further study. Participants will be asked to fill out three questionnaires by phone or by online at day 0, 14 and 30 after the GP-visit.
The main endpoint is the burden of medically attended RSV infection in the Dutch primary care setting, quantified using several clinical and socioeconomic parameters, including (but not limited to) clinical symptoms and their duration, medicine use, hospitalisation rate, quality of life and ability to perform normal daily activities. Secondary, data on health care consumption and indirect costs will be collected and we will assess the effect of age and severe comorbidity on clinical course of RSV disease.
A population size of 1000 older adults age >60 years presenting with acute respiratory symptoms to the general practitioner (GP) during RSV season will be tested for RSV as part of routine care. We expect about 100 RSV+. Based on our sample size calculation, 100 RSV+ cases would provide sufficient accuracy for estimating the relevant outcomes.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (≥60 years of age)
- •RSV positive
- •Subject is willing and able to give informed consent for participation in the study
- •Subject is willing and able to adhere to protocol-specific procedures
排除标准
- •Subject is not able to understand and communicate in the local language or English.
- •Previous or current participation in RSV interventional trial (vaccine, antivirals)
结局指标
主要结局
Burden of medically attended RSV infection in the Dutch primary care
时间窗: Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)
The burden of medically attended RSV infection in the Dutch primary care setting will be defined as severity and duration of clinical symptoms, and healthcare resource use.
次要结局
- Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use(Data will be collected at the last timepoint (30 days after viral swab))
- Association between disease severity and several clinical and demographic parameters (e.g. age, cardiopulmonary comorbidity, smoking status, chronic immunosuppressive medication use) and RSV burden (by disease severity and healthcare usage)(Data will be collected at three timepoints (Day 0, Day 14 and Day 30 after viral swab))
- RSV-related health care consumption and indirect costs in older adults(Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab))
- Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting(At day of sampling (Day 0))