PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Percentage of days Garmin Tracker was worn during antibiotic course
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- Parent/guardian does not speak English
结局指标
主要结局
Percentage of days Garmin Tracker was worn during antibiotic course
时间窗: 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.
Issues with Garmin Tracker use (as recorded on study-specific questionnaires) - reports by frequency
时间窗: Day 14
As reported in the day 14 follow-up questionnaire or the daily symptom questionnaires completed by parent/guardian via WeGuide.
Number of parents/participants who expressed no concerns with study procedures
时间窗: Day 28
As reported in questionnaires completed by parent/guardian via WeGuide.
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
时间窗: Day 14
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency
时间窗: Day 28
As reported in the follow-up questionnaires completed by parent/guardian via WeGuide.
Number of parents willing to be contacted regarding joining a parent group
时间窗: 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 report issues completing study-specific questionnaires
时间窗: Day 28
As reported in the follow-up questionnaire completed by parent/guardian via WeGuide.
Acceptability of the study procedures as measured by a study-specific targeted questionnaire
时间窗: 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.
Acceptability of the Garmin Tracker as measured by a study-specific targeted questionnaire
时间窗: Day 14
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Percentage of completed study-specific questionnaires
时间窗: Baseline through to Day 28
All study specific questionnaires completed by parent/guardian via WeGuide
Number of parents/participants who completed all study-specific procedures
时间窗: 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)
次要结局
- Agreement between reports of fever recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient(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(Baseline to Day 10)
- Number of participants who re-start antibiotics within 28 days of antibiotic commencement as reported in study-specific questionnaire(Day 28)
- Number of reported doses of antibiotics administered versus doses prescribed as reported in study-specific questionnaire(Day 10)
- Agreement between reports of sleep quality recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient(Baseline to Day 10)
- Number of participants who report stopping antibiotics early due to resolution of symptoms - as reported on the study-specific questionnaire(Day 14)
- Reason for stopping antibiotics early as reported on study-specific questionnaire(Day 14)
- Number of participants who finished complete course of antibiotics as reported in study-specific questionnaire(Day 14)
- Number of participants who are still unwell at Day 28 as reported in study-specific questionnaire(Day 28)