Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140446
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-14
Brief Title:
Effect of eHealth on AB Use of Children With Acute Uncomplicated URTIs
Sponsor:
Max Nieuwdorp
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
The study design is a Randomized Controlled Trial RCT in six GP practices There will be three study groups 1 a group of parents who will be advised to use the FeverApp additional to advices from their GP practice 2 a group of parents who will be advised to use the self-care DMT App additional to advices from their GP practice and 3 a control group of parents who will only receive advices from their GP practice Recruitment of parents will be done by the GP practice assistants of the participating practices and selection and inclusion will be carried out by a research assistant from University of Applied Sciences Leiden UAS Leiden Randomization over the conditions will be done at random by the research assistant This will result in parents assigned to either the Fever App group the DMT App group or the control group All included parents will after receiving the participant information fill out a baseline online questionnaire including digital informed consent and will collect a baseline stool sample of their child and save it in the freezer T0 After that parents in the intervention groups download and use the app they were assigned to and all parents report severity of URTI symptoms of their child online at 2 5 and 7 days T1 T2 and T3 in an online form Ten days after T0 all parents fill out a follow-up questionnaire collect a second stool sample from their child and save it in their own -20 degrees Celsius freezer T4 At the end of the study all of the stool samples will be picked up at home by research assistants from UAS Leiden and will be transferred to Amsterdam University Medical Centre for the laboratory gut microbiome analysis
Benefits burden and risks
The benefit of participating in the study is that parents in the intervention groups will get extra support by means of the apps on top of the advices that will be provided by the GP practice For the control group there is no real benefit besides contributing to less AB use among children in the future The burden of this study lies in the fact that parents who participate will have to fill out two online questionnaires within two weeks report symptom severity online at two more timepoints and will have to collect a stool sample of their child twice and save it in the freezer Parents in the intervention groups will get the advice to download and use one of the two investigated apps It will be their own decision to actually do this or not
Participating in the study is safe because only parents of children with mild acute uncomplicated URTIs will be involved Furthermore advicescare by the GP practice will be continued for all patients in the study and the advices in the self-management fever app are in line with national fever guidelines The only difference is that based on the most recent insights on fever the app encourages to keep the child warm in the first phase of fever With regards to safety of the self-care DMT App adverse events due to HM are rare Moreover the herbs that are advised on in the app are freely available without prescription in drugstores and pharmacies in the Netherlands Therefore using the self-care DMT App will make things safer rather than less safe because parents in the HM group will get a trustworthy advice based on scientific evidence and safety regulations instead of buying herbal medicine without an evidence-based decision-making tool DMT like they would normally do
All participating parents will be advised to always go to the national website with GP advices in case of doubts about the health status of their child and to call their GP practice the ED emergency department or 112 in case of alarm symptoms Furthermore all parents are told to report complications from the URTI andor adverse events such as hospitalization to the researchers In case of complications or adverse events they will be will go back to just receiving advicescare from their GPNPPA Participating parents will use the apps in a test account so no data will be collected by the apps Also the online questionnaires they fill out are anonymous so the privacy of parents who participate is secured Finally parents can leave the study at any moment and go back to just receiving advices from their GP practice There is no relation between parents in the different study groups
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
The study design is a Randomized Controlled Trial RCT in six GP practices There will be three study groups 1 a group of parents who will be advised to use the FeverApp additional to advices from their GP practice 2 a group of parents who will be advised to use the self-care DMT App additional to advices from their GP practice and 3 a control group of parents who will only receive advices from their GP practice Recruitment of parents will be done by the GP practice assistants of the participating practices and selection and inclusion will be carried out by a research assistant from University of Applied Sciences Leiden UAS Leiden Randomization over the conditions will be done at random by the research assistant This will result in parents assigned to either the Fever App group the DMT App group or the control group All included parents will after receiving the participant information fill out a baseline online questionnaire including digital informed consent and will collect a baseline stool sample of their child and save it in the freezer T0 After that parents in the intervention groups download and use the app they were assigned to and all parents report severity of URTI symptoms of their child online at 2 5 and 7 days T1 T2 and T3 in an online form Ten days after T0 all parents fill out a follow-up questionnaire collect a second stool sample from their child and save it in their own -20 degrees Celsius freezer T4 At the end of the study all of the stool samples will be picked up at home by research assistants from UAS Leiden and will be transferred to Amsterdam University Medical Centre for the laboratory gut microbiome analysis
Benefits burden and risks
The benefit of participating in the study is that parents in the intervention groups will get extra support by means of the apps on top of the advices that will be provided by the GP practice For the control group there is no real benefit besides contributing to less AB use among children in the future The burden of this study lies in the fact that parents who participate will have to fill out two online questionnaires within two weeks report symptom severity online at two more timepoints and will have to collect a stool sample of their child twice and save it in the freezer Parents in the intervention groups will get the advice to download and use one of the two investigated apps It will be their own decision to actually do this or not
Participating in the study is safe because only parents of children with mild acute uncomplicated URTIs will be involved Furthermore advicescare by the GP practice will be continued for all patients in the study and the advices in the self-management fever app are in line with national fever guidelines The only difference is that based on the most recent insights on fever the app encourages to keep the child warm in the first phase of fever With regards to safety of the self-care DMT App adverse events due to HM are rare Moreover the herbs that are advised on in the app are freely available without prescription in drugstores and pharmacies in the Netherlands Therefore using the self-care DMT App will make things safer rather than less safe because parents in the HM group will get a trustworthy advice based on scientific evidence and safety regulations instead of buying herbal medicine without an evidence-based decision-making tool DMT like they would normally do
All participating parents will be advised to always go to the national website with GP advices in case of doubts about the health status of their child and to call their GP practice the ED emergency department or 112 in case of alarm symptoms Furthermore all parents are told to report complications from the URTI andor adverse events such as hospitalization to the researchers In case of complications or adverse events they will be will go back to just receiving advicescare from their GPNPPA Participating parents will use the apps in a test account so no data will be collected by the apps Also the online questionnaires they fill out are anonymous so the privacy of parents who participate is secured Finally parents can leave the study at any moment and go back to just receiving advices from their GP practice There is no relation between parents in the different study groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None