Effect of Two eHealth Applications on Antibiotic Use for Acute, Uncomplicated Upper Respiratory Tract Infections in Children: a Randomized Controlled Trial Among Parents in Dutch General Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Antibiotic use (yes/no)
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of two self-care eHealth applications in parents of children with uncomplicated upper respiratory tract infections (URTIs).
The main question it aims to answer is:
• What is the effect of a self-management FeverApp and a self-care herbal medicine decision making tool (DMT) on reducing antibiotic use for acute, uncomplicated URTIs, among children in Dutch general practice?
Participants will:
- Complete an online questionnaire at baseline
- Use a self-care eHealth application for ten days (in the intervention groups)
- Report symptom severity of the URTI of their child online at day 2, 5 an 7
- Complete an online follow-up questionnaire at day 10
- Collect two stool samples of their child at baseline and at day 10
Researchers will compare three groups to see if the Apps have an effect on recovery time and complications from URTIs, AB use, frequency of GP visits, and diversity of the gut microbiome:
- Parents that will use an evidence based fever app additional to standard advices of their GP
- Parents that will use an evidence based herbal medicine DMT additional to standard advices of their GP
- A control group of parents who will receive just standard advices from their GP,
详细描述
Rationale:
Antimicrobial resistance (AMR) is a complex and growing international public health problem with important consequences as increased mortality and high economic impact. Less inappropriate antibiotic (AB) prescription is one of the global strategies to reduce AMR. In primary care most inappropriate AB prescriptions are for acute, uncomplicated respiratory tract infections (URTIs). URTIs are among the most frequently seen complaints among children in general practice. ABs are only indicated for URTis in case of complications. Nevertheless, they are still often prescribed for uncomplicated cases. A reason for this could be worried parents parents requesting for an AB prescription for their child. In Dutch primary care, ABs can be prescribed by general practitioners (GPs), nurse practitioners (NPs) and physician assistants (PAs). Besides AMR, ABs can cause damage to the gut microbiome. Adequate fever (self) management and safe use of effective (self-care) herbal medicine (HM) are both expected to reduce AB use in mild, acute uncomplicated URTIs. Therefore, a (self-management) FeverApp and a (self-care) herbal medicine decision making tool (DMT App) were developed for parents in general practice.
Objectives:
The primary objective of this study is to investigate the effect of a self-management FeverApp and a self-care DMT App on reducing antibiotic use for acute, uncomplicated URTIs, among children in Dutch general practice. Secondary objectives are to examine (1) amount of apps-related complications and recovery time from acute, uncomplicated URTIs in comparison to standard GP advices, (2) the effect of apps use on reducing the number of GP practice visits and telephone consultations for acute, uncomplicated URTIs, and (3) the effects of apps use (reducing AB use) on diversity of the gut microbiome.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a child aged 0-12 years old
- •Master the Dutch language
- •Having called the GP for their child aged 0-12 years having:
- •Fever (≥38 °C) AND
- •At least one of the following symptoms:
- •Acute cough
- •Sore throat
- •Earache/runny ear
- •Nasal congestion/runny nose
- •Being screened by a triage specialist (GP practice assistant) and not being indicated for a GP/NP/PA visit
- •Not being included in the trial before
排除标准
- •The current URTI complaints of the child already exist longer than 2 weeks
- •The child who has a URTI
- •is younger than 3 months old
- •has asthma or another chronic or severe illness
- •has a history of pneumonia
- •has a history of complications or hospitalization from a previous URTI
- •has Down Syndrome
- •has a less functioning immune system
- •The parent being very worried
结局指标
主要结局
Antibiotic use (yes/no)
时间窗: Self-reported10 days after inclusion in the study
Antibiotic use of the child in the current URTI episode
次要结局
- Normal recovery time from URTI(Self-reported 10 days after inclusion in the study)
- Adverse events/complications(Self-reported 10 days after inclusion in the study)
- GP visits(Self-reported 10 days after inclusion in the study)
- Telephone consultations(Self-reported 10 days after inclusion in the study)
- Gut microbiome diversity(At baseline (inclusion) AND 10 days after inclusion in the study)
- AB type(Self-reported at 10 days after inclusion in the study)
- AB dosage(Self-reported at 10 days after inclusion in the study)
研究者
Max Nieuwdorp
Clinical professor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)