About this trial
The study will assess families' perspectives and decision-making regarding the duration of oral antibiotic courses prescribed to children (4-17 years) who present with uncomplicated bacterial infections at the Royal Children's Hospital (RCH) Emergency Department (ED). The study will involve (i) children discharged from ED on oral antibiotics and (ii) children transferred to Hospital-in-the-Home (HITH) on IV antibiotics who then switch to oral antibiotics. In addition, the study will assess how feasible and acceptable it is to track children's symptoms via the Garmin Smartwatch and the WeGuide platform (WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection \[via questionnaires/surveys and from the Garmin Smartwatches\] through a singular platform).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of ≥ 4 years and ≤ 17 years at enrolment.
Diagnosed with any of the following at RCH ED: urinary tract infection (UTI), cellulitis, impetigo, pharyngitis, tonsillitis, respiratory tract infections, otitis media.
Prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care due to having uncomplicated infection as deemed by their treating doctor.
Parent/guardian provides a signed and dated informed consent form.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Garmin Smartwatch
DeviceGarmin Venu 3 - Worn for the duration of antibiotic course
Treatment groups
Trial outcomes
Primary outcomes
Percentage of days Garmin Tracker was worn during antibiotic course
Participants will wear the Garmin Tracker for the duration of their antibiotic course. Number of days Garmin Tracker worn collected via WeGuide app. WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection (via questionnaires/surveys and from the Garmin Smartwatches) through a singular platform.
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Issues with Garmin Tracker use (as recorded on study-specific questionnaires) - reports by frequency
As reported in the day 14 follow-up questionnaire or the daily symptom questionnaires completed by parent/guardian via WeGuide.
Secondary outcomes
Agreement between reports of fever recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient
As assessed by Garmin Tracker and study-specific daily questionnaires completed by parent/guardian via WeGuide
Agreement between reports of sleep quality recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient
As assessed by Garmin Tracker and in study-specific daily questionnaires completed by parent/guardian via WeGuide
Agreement between reports for activity level recorded by the Garmin Tracker versus reports of daytime lethargy/tiredness in the daily questionnaire
As assessed by Garmin Tracker and in study specific daily questionnaires completed by parent/guardian via WeGuide
Number of participants who re-start antibiotics within 28 days of antibiotic commencement as reported in study-specific questionnaire
As reported in the study-specific day 28 follow-up questionnaire completed by parent/guardian via WeGuide.
Sponsors and contacts
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Murdoch Childrens Research Institute
Lead sponsor
Royal Children's Hospital
Collaborator