A Clinical Registry for Children presenting to Hospital with Respiratory Infections.
The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) - Clinical Registry
Telethon Kids Institute
4,000 participants
Feb 9, 2020
Observational
Conditions
Summary
The aim of PATRIC Clinical Registry is to develop improved evidence-based treatment of Acute Respiratory Infections (ARI), the most common reason that children attend the emergency department (ED) for care. The data collected by the PATRIC Clinical Registry will evaluate current treatments for ARI in a variety of patient groups and provide a platform the PATRIC Clinical Trial that will test various interventions in ARI treatment and management. The PATRIC Clinical Registry will recruit parents and children from the Emergency Department at Perth Children's Hospital (PCH) utilising an informative video and e-consent form. The informative video and e-consent are accessed via a study iPad. A baseline survey immediately follows completion of e-consent with a link sent to the parent's smartphone that can be completed later, if necessary. Following this, engagement with parents will continue with weekly follow-up e-surveys until Day 28, unless they report their child is no longer sick or choose to withdraw from the study.
Eligibility
Inclusion Criteria6
- To be eligible to participate in the PATRIC Clinical Registry, a participant must meet the following criteria:
- Children aged greater than or equal to 1 months of age and less than or equal to 15 years.
- Symptoms and signs of ARI:
- a. A documented fever greater than or equal to 37.5°C or history of fever in the past 96 hours AND
- b. Acute respiratory symptoms including cough and/or flu-like symptoms (e.g. sore throat, rhinorrhoea, fatigue)
- Total duration of symptoms <21 days at time of enrolment.
Exclusion Criteria5
- Potentially eligible individual who meets any of the following criteria will be excluded from participation if the following criteria is met:
- Children less than 1 month old or greater than 15 years
- Previous participation in PATRIC within the last 3 months
- Parents whose English is insufficient to understand study materials
- Parents unwilling/unable to provide consent
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Interventions
The PATRIC Clinical Registry will collect baseline data for children presenting to Perth Children's Hospital with an Acute Respiratory Infection. Emergency Department staff (clinical and/or research staff) will identify and approach prospective participants. ED staff will provide study information (paper or digital) to gain informed consent. Study consent can be obtained by hard paper copy or digitally via a REDCap consent form on a study provided iPad. Once consent is obtained, parents will then be asked to complete a baseline survey on the iPads or via a link sent to their smartphone. Parents will then be contacted via their smartphones for up to four short follow-up surveys (weekly follow up - for a maximum of 4 weeks in total). Each survey will take 5-10 minutes to complete, which will ask questions about parental anxiety, the child's symptoms, the child's level of activity, seeking further healthcare and further treatment. In addition, parents will be asked to provide consent for access to their children's medical records and vaccination history. Parents are given the option to withdraw from the Clinical Registry at any time. At the beginning of each follow-up survey parents will be asked if they are happy to continue to participate in the registry and if they answer with 'no' they are not sent any further surveys. Participation in the registry also stops once parents indicate in the follow-up survey that their child is no longer sick. If this occurs, parents won't be sent any further follow-up surveys and are thanked for their time participating in the registry.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619000903189