Perspectives on Antibiotics and Tracking Symptoms in Children
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Garmin Smartwatch.
- Кому может быть актуально
- Состояния в реестре: Urinary Tract Infection, Cellulitis, Impetigo, Pharyngitis. Базовые параметры: 4 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study
Обзор
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).
Подробное описание
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.
Вмешательства
- Устройство Garmin Smartwatch
Garmin Venu 3 - Worn for the duration of antibiotic course
Первичные конечные точки
- Percentage of days Garmin Tracker was worn during antibiotic course [Срок оценки: Baseline through to Day 10]
- Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use [Срок оценки: Day 10]
- Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use [Срок оценки: Day 14]
- Issues with Garmin Tracker use (as recorded on study-specific questionnaires) - reports by frequency [Срок оценки: Day 14]
- Acceptability of the Garmin Tracker as measured by a study-specific targeted questionnaire [Срок оценки: Day 14]
- Percentage of completed study-specific questionnaires [Срок оценки: Baseline through to Day 28]
- Number of parents/participants who report issues completing study-specific questionnaires [Срок оценки: Day 10]
- Number of parents/participants who report issues completing study-specific questionnaires [Срок оценки: Day 28]
- Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency [Срок оценки: Day 10]
- Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency [Срок оценки: Day 28]
Вторичные конечные точки (9)
- Agreement between reports of fever recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline to Day 10]
- Number of participants who re-start antibiotics within 28 days of antibiotic commencement as reported in study-specific questionnaire [Срок оценки: Day 28]
- Number of participants who are still unwell at Day 28 as reported in study-specific questionnaire [Срок оценки: Day 28]
- Number of participants who finished complete course of antibiotics as reported in study-specific questionnaire [Срок оценки: Day 14]
- Number of reported doses of antibiotics administered versus doses prescribed as reported in study-specific questionnaire [Срок оценки: Day 10]
- Number of participants who report stopping antibiotics early due to resolution of symptoms - as reported on the study-specific questionnaire [Срок оценки: Day 14]
- Reason for stopping antibiotics early as reported on study-specific questionnaire [Срок оценки: Day 14]
Критерии участия
Критерии включения
- 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.
Критерии исключения
\- Parent/guardian does not speak English
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Австралия · 1 центр
- Royal Children's Hospital — Melbourne
Идентификаторы
NCT: NCT07093749 · 116407