RecruitingACTRN12619000903189

A Clinical Registry for Children presenting to Hospital with Respiratory Infections.

The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) - Clinical Registry

Sponsor

Telethon Kids Institute

Enrollment

4,000 participants

Start Date

Feb 9, 2020

Study Type

Observational

Conditions

Acute Respiratory Infection/ Respiratory Infections Infectious Diseases

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

Sex: Both males and femalesMin Age: 1 MonthsMax Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

Respiratory infections — colds, flu, croup, bronchiolitis, and pneumonia — are the most common reason children end up in the emergency department. Despite how frequently these illnesses occur, there is surprisingly limited evidence about which treatments work best for which children. The PATRIC Registry is a large database being built to collect detailed, real-world information about how children with respiratory infections present, how they are treated, and how they recover over the following four weeks. Parents of children aged 1 month to 15 years who come to Perth Children's Hospital with symptoms of a respiratory infection (fever, cough, or flu-like symptoms within the last 3 weeks) will be invited to participate. Using a tablet in the emergency department, parents will watch a short video and provide consent digitally. They will then receive follow-up surveys by phone each week for four weeks after the visit. Families who do not have sufficient English to understand the materials, or who are unwilling to provide consent, are not eligible. Children under 1 month old or over 15 years are also excluded. This registry will serve as the foundation for future clinical trials testing new treatments for childhood respiratory infections, giving researchers the tools to design studies that reflect the real diversity of children affected.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.