Urinary Tract InfectionCellulitisImpetigoPharyngitisTonsillitisRespiratory Tract InfectionsOtitis Media
Investigational drug(s) / intervention(s)
Garmin Smartwatch
Garmin Smartwatch: Garmin Venu 3 - Worn for the duration of antibiotic course
Study summary
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
Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
\- Parent/guardian does not speak English
Primary outcome measure(s)
Percentage of days Garmin Tracker was worn during antibiotic course — Baseline through to Day 10 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 — Day 10 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 — Day 14 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 — Day 14 As reported in the day 14 follow-up questionnaire or the daily symptom questionnaires completed by parent/guardian via WeGuide.
Acceptability of the Garmin Tracker as measured by a study-specific targeted questionnaire — Day 14 As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Percentage of completed study-specific questionnaires — Baseline through to Day 28 All study specific questionnaires completed by parent/guardian via WeGuide
Number of parents/participants who report issues completing study-specific questionnaires — Day 10 As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Number of parents/participants who report issues completing study-specific questionnaires — Day 28 As reported in the follow-up questionnaire completed by parent/guardian via WeGuide.
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency — Day 10 As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency — Day 28 As reported in the follow-up questionnaires completed by parent/guardian via WeGuide.
Number of parents/participants who expressed no concerns with study procedures — Day 28 As reported in questionnaires completed by parent/guardian via WeGuide.
Acceptability of the study procedures as measured by a study-specific targeted questionnaire — Day 28 Targeted questions will be asked to the parent/guardian to elicit feedback on study experience. Open-ended questions analysed via thematic analysis, closed-ended questions assessed as a percentage of each response.
Number of parents willing to be contacted regarding joining a parent group — Day 28 Parents will be asked if they are willing to be contacted regarding participation in an upcoming parent group. The parent group will helps us understand parent/child points of view in antibiotic research and provide consumer input into the development of the upcoming clinical trial.
Number of parents/participants who completed all study-specific procedures — Day 28 All study-specific procedures completed by parent/guardian via WeGuide - includes questionnaires and Garmin Tracker use (for those participants that are invited to and consent to wearing)
Trial sites (1)
Facility
City
Region
Status
Royal Children's Hospital
Melbourne
Victoria
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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