A Comparison of Respiratory Sample Collection by a Parent or by a Healthcare Worker

NCT ID: NCT00966069

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Healthcare worker home visit

Intervention Type: OTHER

Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.

Parent collection

Home collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness.

Group Type: EXPERIMENTAL

Parent collection

Intervention Type: OTHER

Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.

Interventions

Parent collection

Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Dr Stephen Lambert

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith Grimwood, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Theo P Sloots, PhD

Role: PRINCIPAL_INVESTIGATOR

Queensland Paediatric Infectious Diseases Laboratory

Michael D Nissen, FRACP

Role: PRINCIPAL_INVESTIGATOR

Queensland Paediatric Infectious Disease Laboratory

Stephen B Lambert, MBBS

Role: PRINCIPAL_INVESTIGATOR

Queensland Paediatric Infectious Diseases Laboratory

Locations

Queensland Children's Medical Research Institute

Brisbane, Queensland, Australia

Countries

Australia

References

Zoch-Lesniak B, Ware RS, Grimwood K, Lambert SB. The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged <2 Years. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):134-141. doi: 10.1093/jpids/piy136.

Reference Type: DERIVED

PMID: 30657971 (View on PubMed)

Other Identifiers

HREC/09/QRCH/42

Identifier Type: -

Identifier Source: org_study_id