A Comparison of Respiratory Sample Collection by a Parent or by a Healthcare Worker (ReSPeCT)
Respiratory Tract Infections
Other: Parent collection
Other: Healthcare worker home visit
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||ReSPeCT: An Unblinded, Randomised, Controlled Trial to Compare Respiratory Sample Collection by a Parent or by a Healthcare Worker at a Home Visit|
- Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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).
- Proportion of specimens collected that have a virus able to be detected. [ Time Frame: 6 months ] [ Designated as safety issue: No ]For this outcome, the Investigators will compare the proportion of all specimens collected during incident ARIs in each group (HCW vs parent collection) that have any virus detected.
- Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab). [ Time Frame: 6 months ] [ Designated as safety issue: No ]This comparison is restricted to children randomised to the health care worker collection group. In this group, at the home visit the HCW will collect a nasopharyngeal swab, place it in universal transport media, and return it immediately to the laboratory. At the same home visit, a parent will collect a dry anterior nasal swab, it will be placed in a post box near the subject's home, and returned to the laboratory by normal surface mail. For this outcome, the Investigators will compare the proportion of all specimens collected during incident ARIs in the HCW group that have any virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).
|Study Start Date:||August 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Healthcare worker visit
Healthcare worker performs home visit when study child has acute respiratory illness to collect a respiratory swab (nasopharyngeal swab).
At the healthcare worker home visit, the HCW will collect the nasopharyngeal swab, and a parent will collect an anterior nasal swab. The HCW swab is to be returned immediately to the laboratory, and the parent collected swab was placed in a post box for return to the laboratory by surface mail.
Other: Healthcare worker home visit
Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.
Experimental: Parent collection
Home collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness.
Other: Parent collection
Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.
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.
We have previously shown that a swab combined with viral transport medium-soaked sponge in a secure transport tube is an efficient and safe way of transporting respiratory swabs. The method complies with guidelines for the transport of clinical specimens. As part of this study, we will use this system to allow for the transport of respiratory specimens to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory through the normal surface mail, thereby allowing study families to manage specimen collection and return without the intervention of a study staff member.
Flocked swabs in combination with specific viral transport media have recently been added to specimen collection options, allowing for simple and sensitive specimen collection whilst avoiding more invasive nasopharyngeal aspirates or washes.
With this study, we plan to compare parent and health care worker collection using flocked swabs, and for some specimens they will be returned to the laboratory through normal surface mail.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966069
|Queensland Children's Medical Research Institute|
|Brisbane, Queensland, Australia, 4029|
|Principal Investigator:||Keith Grimwood, MD||Queensland Children's Medical Research Institute|
|Principal Investigator:||Theo P Sloots, PhD||Queensland Paediatric Infectious Diseases Laboratory|
|Principal Investigator:||Michael D Nissen, FRACP||Queensland Paediatric Infectious Disease Laboratory|
|Principal Investigator:||Stephen B Lambert, MBBS||Queensland Paediatric Infectious Diseases Laboratory|