ReSPeCT: An Unblinded, Randomised, Controlled Trial to Compare Respiratory Sample Collection by a Parent or by a Healthcare Worker at a Home Visit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory.
研究概览
简要总结
The investigators are aiming to learn more about respiratory infections in young children in the community. To prepare for a larger project, the investigators are conducting this study to get information about the best way to collect and transport respiratory specimens from young children. The investigators would like to test whether parents are more likely to collect a simple respiratory specimen themselves during a child's illness, compared to the likelihood of specimen collection when a home visit is made by a health care worker. Further, the investigators want to compare the likelihood a virus will be identified in both groups.
详细描述
Prior to this study, there had been one small study conducted in the Netherlands comparing parent-collected specimens at home with collection by a health care worker (HCW) during an arranged home visit. This study suggested that despite there being approximately the same number of illnesses identified in each group, the parent collection group had a higher proportion of ARIs with a specimen collected (43% vs 24%, parent vs HCW home visit), and a higher proportion of specimens tested positive for a virus (80% vs 67%), although neither of these findings was statistically significant.
In order to prepare for a larger, community based study, we would like to test these findings in our environment.
Community-based respiratory infection research has traditionally been conducted by home visit from a health care worker during illness to collect a sample, such as a nasopharyngeal aspirate. This method has the potential to result in non-reporting of illness or failure to collect a specimen due to the invasive nature of specimen collection or the difficulty arranging a home visit time that is convenient for parents and staff. This may bias findings and interfere with generalisability.
Home collection of a simple respiratory sample has recently been demonstrated as an easy and acceptable method of conducting community-based respiratory research. Members of our group were involved in a large, community-based study in Melbourne involving 234 children and their families over a 12-month period. On this study parents successfully kept daily respiratory symptom diaries and collected a combined nose-throat swab when the child had an illness that met the definition for an acute respiratory illness (ARI) of interest. These study methods were acceptable with 87% parents reporting, at the end of the study, they would have been willing to continue with the study for at least another year.
Since that study, parent collection of simple respiratory specimens has been further validated in the hospital setting and used in the home setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children, 0 to 23 months of age at enrolment (not reached their 2nd birthday)
- •born between 36 and 42 weeks gestational age
- •written informed consent from parent/guardian (available for telephone contact)
- •parent willing to collect an anterior nasal specimen from the study child when meets criteria for ARI of interest
排除标准
- •children with chronic pulmonary or cardiovascular disorders (including diagnosed asthma, or frequent use of asthma medication)
- •children with chronic metabolic disorders (such as but not limited to diabetes mellitis, renal dysfunction, haemoglobinopathies)
- •children with immune system disorders (such as HIV/AIDS or receiving immune system suppressing medications)
- •children with other chronic illnesses whose enrolment is deemed by the investigators to make it inappropriate to enrol them onto the study
- •parent or guardian with sufficient English language skills to complete study diaries and perform study tasks as required
结局指标
主要结局
Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory.
时间窗: 6 months
For this outcome, the Investigators will compare the proportion of all incident ARIs that have a specimen available for testing in each group (HCW vs parent collection).
次要结局
- Proportion of specimens collected that have a virus able to be detected.(6 months)
- Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).(6 months)
研究者
Dr Stephen Lambert
Senior Research Fellow
The University of Queensland