Effect of eHealth on AB Use of Children With Acute, Uncomplicated URTIs

Summary

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,

Conditions

• Upper Respiratory Tract Infection

Interventions

DEVICE

FeverApp

The (self-management) FeverApp contains evidence-based information about fever and how to deal with it, tailored (phase-oriented) fever advices, and the option to monitor the health status of the child during a fever episode. All information and advices are based on the clinical expertise of paediatricians and the most recent international literature on fever, and complement the Dutch national fever guidelines. It is expected that by letting the body fight the infection on its own in a safe way, less ABs are needed, and the immune system will get stronger leading to less future infections as well.

DEVICE

DMT App

The (self-care) DMT App is a decision making tool (DMT) that can be used by parents to choose a safe and effective herbal medicine (HM) product to reduce symptoms of mild, acute uncomplicated URTIs in their child. The advices that the DMT App provides, are based on a systematic review (SR) of SRs on effectiveness of HM for URTIs, a SR on working mechanisms of the most promising herbs, a prescription rates study of HM for URTIs in 6 European countries, and current EMA status of the included herbs. No prescription from a doctor is needed for these products.

Sponsors & Collaborators

• Max Nieuwdorp

  lead OTHER

Principal Investigators

• Max Nieuwdorp, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-31

Primary Completion

2024-05-31

Completion

2024-05-31

Countries

• Netherlands

Study Locations