A mHealth Intervention to Improve Symptom Control in Children &

Status Recruiting

Clinical Trial Summary

Asthma is the most common chronic respiratory disease worldwide. Despite advances in asthma management, control of the disease is still a challenge especially among children. Information and communications technology (ICT) have been recently used in clinical practice to increase awareness of diseases, encourage patients to engage in the management of their conditions and improve monitoring and surveillance. The investigators of this study will test a new digital platform combining online/offline content aimed to improve asthma control and reduce exacerbations and unnecessary consultations in children with difficult-to-control asthma. A randomised controlled trial enrolling 60 patients allocated in two groups has been designed. The intervention group (IG) will be granted free access during 6 months to a web-based platform. During this period, patient will have access to online/off line content to improve disease awareness, monitor signs and symptoms and will also get the support of a respiratory coach. In addition, patients in this group will receive an electronic peak flow meter to register daily variations in maximal expiratory flow and an electronic device to connect to their inhaler to track adequate intake of inhaled medication. The control group (CG) will receive usual care consisted of scheduled visitations to medical doctors every 4 - 8 weeks. Both groups will be evaluated at baseline, post-intervention (6 months) and at follow up (one year) in the following variables: age, gender, asthma severity classification according to international guidelines, date of diagnosis, weight, height, Body Mass Index (BMI), forced expiratory volume in 1 second (FEV1), Asthma Control Questionnaire score, treatment received for asthma, number of exacerbations in the previous 6 months and concomitant diseases. Exacerbations will be defined as any worsening in asthma symptoms that requires an increase in the usual therapy, an unscheduled physician visit, treatment in the emergency room or hospitalization.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04166344
Study type	Interventional
Source	Lovexair Foundation
Contact	Raquel Sebio-Garcia, PhD
Phone	+34679336288
Email	raquelsebio@lovexair.com
Status	Recruiting
Phase	N/A
Start date	September 1, 2021
Completion date	September 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Recruiting	`NCT05734261` - Forced Oscillations Technique During a Metacholine Test in Children	N/A
Recruiting	`NCT06044051` - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma	N/A
Completed	`NCT04896502` - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers	N/A
Completed	`NCT03503812` - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches	N/A
Recruiting	`NCT06003569` - Reducing Asthma Attacks in Disadvantaged School Children With Asthma	N/A
Not yet recruiting	`NCT05902702` - Isotonic Saline for Children With Bronchiolitis	N/A
Not yet recruiting	`NCT05547477` - Continuous EMG Measurements in Children With Asthma During Sleep
Completed	`NCT04388098` - Oral Health Status of Asthmatic Children
Terminated	`NCT03586544` - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity	Phase 4
Recruiting	`NCT04821908` - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting	`NCT03277170` - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations	Phase 2
Enrolling by invitation	`NCT06239844` - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English	N/A
Not yet recruiting	`NCT05997784` - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Not yet recruiting	`NCT05974917` - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Recruiting	`NCT05366309` - Performance and Adherence in Children Using Spacers	N/A
Completed	`NCT05684926` - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga	N/A
Completed	`NCT03907410` - The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial	N/A
Completed	`NCT05576142` - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Completed	`NCT03673618` - Soluble Corn Fiber Supplementation for Asthma	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms