Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Royal Children's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | All participants eligible participants parent/guardian will be asked to complete:
In addition, a small number of participants will also be asked to wear a Garmin Smartwatch for the duration of their antibiotic course (3 devices only available, will be offered when available - approximately 60 participants). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garmin Smartwatch | Device | Garmin Venu 3 - Worn for the duration of antibiotic course |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through to Day 10 |
| 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. | Day 10 |
| 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. | Day 14 |
| 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. | Day 14 |
| Acceptability of the Garmin Tracker as measured by a study-specific targeted questionnaire | As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide. | Day 14 |
| Percentage of completed study-specific questionnaires | All study specific questionnaires completed by parent/guardian via WeGuide |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Day 10 |
| Agreement between reports of sleep quality recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Parent/guardian does not speak English
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A/Prof Penelope Bryant | Contact | +61383416200 | penelope.bryant@rch.org.au | |
| Lucy Hill | Contact | +61383416200 | lucy.hill@mcri.edu.au |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Children's Hospital | Recruiting | Melbourne | Victoria | 3052 | Australia |
Individual participant data that underlie the results that are published after de-identification (text, tables, figures and appendices) will be made available long-term for use by future researchers from a recognised research institution who meet access criteria as outlined below.
12 months following analysis and publication of the subsequent planned clinical trial.
Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D002481 | Cellulitis |
| D007169 | Impetigo |
| D010612 | Pharyngitis |
| D014069 | Tonsillitis |
| D012141 | Respiratory Tract Infections |
| D010033 | Otitis Media |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
This is a largely observational study with a small device feasibility portion. The primary outcome of the study is looking at feasibility and satisfaction of study instruments. In addition, approximately 60 of the anticipated total of 300 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 surveys) in order to determine level of agreement and investigate if further research into the devices use may be useful.
Not provided
Not provided
Not provided
Not provided
| Baseline through to Day 28 |
| Number of parents/participants who report issues completing study-specific questionnaires | As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide. | Day 10 |
| Number of parents/participants who report issues completing study-specific questionnaires | As reported in the follow-up questionnaire completed by parent/guardian via WeGuide. | Day 28 |
| Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency | As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide. | Day 10 |
| Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency | As reported in the follow-up questionnaires completed by parent/guardian via WeGuide. | Day 28 |
| Number of parents/participants who expressed no concerns with study procedures | As reported in questionnaires completed by parent/guardian via WeGuide. | Day 28 |
| Acceptability of the study procedures as measured by a study-specific targeted questionnaire | 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. | Day 28 |
| Number of parents willing to be contacted regarding joining a parent group | 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. | Day 28 |
| Number of parents/participants who completed all study-specific procedures | 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) | Day 28 |
As assessed by Garmin Tracker and in study-specific daily questionnaires completed by parent/guardian via WeGuide |
| Baseline to Day 10 |
| 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 | Baseline to Day 10 |
| 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. | Day 28 |
| Number of participants who are still unwell at Day 28 as reported in study-specific questionnaire | As reported in the study-specific day 28 follow-up questionnaire completed by parent/guardian via WeGuide. | Day 28 |
| Number of participants who finished complete course of antibiotics as reported in study-specific questionnaire | As reported in the study-specific day 14 follow-up questionnaire completed by parent/guardian via WeGuide. Participant who finished complete course of antibiotics is defined as a participant whose parent reports that all prescribed doses are administered exactly as prescribed in the study specific questionnaire delivered via WeGuide | Day 14 |
| Number of reported doses of antibiotics administered versus doses prescribed as reported in study-specific questionnaire | As reported in study-specific daily questionnaires completed by parent/guardian via WeGuide | Day 10 |
| Number of participants who report stopping antibiotics early due to resolution of symptoms - as reported on the study-specific questionnaire | Stopping antibiotics early as reported in day 14 follow-up questionnaire completed by parent/guardian via WeGuide. Symptom resolution defined as normalisation of Garmin Tracker health parameters or parent/guardian reporting of no symptoms in daily symptom questionnaire completed via WeGuide. | Day 14 |
| Reason for stopping antibiotics early as reported on study-specific questionnaire | As reported in the study-specific day 14 follow-up questionnaire completed by parent/guardian via WeGuide. | Day 14 |
| D052801 | Male Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012871 | Skin Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010031 | Otitis |
| D004427 | Ear Diseases |