Trials / Recruiting

RecruitingNCT07093749

Perspectives on Antibiotics and Tracking Symptoms in Children

PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 300 (estimated)

Sponsor: Murdoch Childrens Research Institute · Academic / Other
Sex: All
Age: 4 Years – 17 Years
Healthy volunteers: Not accepted

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).

Detailed description

This is a mainly observational study looking at the feasibility and acceptability of the study instruments and procedures to be incorporated into an upcoming clinical trial. Parents/guardians will be asked to provide feedback on study procedures and questionnaires. The study will also assess feasibility and acceptability of a shorter course of antibiotic therapy (i.e. stopping earlier) to be tested in the upcoming clinical trial (noting that no antibiotics will be stopped early in this study). The study will also include a clinical trial component. A small number of participants will be invited to wear a Garmin Smartwatch to collect data about heart rate, heart rate variability, skin temperature and sleep and activity levels. Data collected with the Garmin Smartwatch will be compared to parent reported symptoms (collected via the questionnaires noted above) in order to determine the level of agreement. All study surveys and Garmin data will be collected through 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. Study participants will be children (4-17 years of age) who present to the RCH with uncomplicated bacterial infections and are prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care, to assess their and their parents' satisfaction with the study instruments employed in this study, in preparation for the upcoming clinical trial. WeGuide and Garmin are supporting the PATSy study through the WeGuide and Garmin Health Grant for Digital Health and Wellbeing. The grant includes use of the WeGuide platform and the Garmin Trackers. WeGuide and Garmin have no role in recruitment, data collection, data analysis or publication of the study.

Conditions

Interventions

Type	Name	Description
DEVICE	Garmin Smartwatch	Garmin Venu 3 - Worn for the duration of antibiotic course

Timeline

Start date: 2025-09-16
Primary completion: 2026-06-01
Completion: 2026-08-01
First posted: 2025-07-30
Last updated: 2025-09-22

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT07093749. Inclusion in this directory is not an endorsement.