Perspectives on Antibiotics and Tracking Symptoms in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorMurdoch Childrens Research Institute

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Garmin Smartwatch

    Device

    Garmin Venu 3 - Worn for the duration of antibiotic course

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline through to Day 10
2

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.

Time frame
Day 10
3

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.

Time frame
Day 14
4

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.

Time frame
Day 14

Secondary outcomes

1

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

Time frame
Baseline to Day 10
2

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

Time frame
Baseline to Day 10
3

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

Time frame
Baseline to Day 10
4

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.

Time frame
Day 28

Other outcomes

Sponsors and contacts

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Murdoch Childrens Research Institute

Lead sponsor

Royal Children's Hospital

Collaborator