NCT06140446

Brief 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,

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 14, 2023

Last Update Submit

November 19, 2023

Conditions

Upper Respiratory Tract Infection

Keywords

eHealthAntibioticsGut microbiomeGeneral practice

Outcome Measures

Primary Outcomes (1)

  • Antibiotic use (yes/no)

    Antibiotic use of the child in the current URTI episode

    Self-reported10 days after inclusion in the study

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (3)

FeverApp group

EXPERIMENTAL

Use af a self-care FeverApp (containing fever advices and a monitoring function for their child with an uncomplicated URTI), additional to standard advices of the GP.

Device: FeverApp

DMT group

EXPERIMENTAL

Use of a self-care decision making tool (to choose a herbal medicinal product for their child with an uncomplicated URTI), additional to standard advices from their GP.

Device: DMT App

Control group

NO INTERVENTION

Just standard advices from the GP for their child with an uncomplicated URTI.

Interventions

FeverAppDEVICE

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.

FeverApp group
DMT AppDEVICE

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.

DMT group

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Headache
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

Location

Related Publications (1)

  • Belt-van Zoen E, van Steenbergen N, Veldman L, Nieuwdorp M, Baars EW. Evaluating the effects of two parental self-management eHealth applications on antibiotic use, number of primary care visits and gut microbiota of febrile Dutch children with acute, uncomplicated upper respiratory tract infections: a study protocol for a randomised controlled trial. BMJ Open. 2025 Dec 19;15(12):e101463. doi: 10.1136/bmjopen-2025-101463.

    PMID: 41419287DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Max Nieuwdorp, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY DIRECTOR

Central Study Contacts

Eefje Belt-van Zoen, MSc

CONTACT

+31648134012belt.e@hsleiden.nl

Noortje van Steenbergen, MSc

CONTACT

+31618523072steenbergen.van.n@hsleiden.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 20, 2023

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

NL(1)