Telemonitoring of Lung Function by Spirometry

NCT04447664 | Unknown

• 1 other identifier: TMED_SPIRO_001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is the most common respiratory disorder in children that causes breathing problems. The patients may have respiratory symptoms such as cough, wheeze, or short of breath. Asthma can be mild or severe when daily activities become compromised. Generally, by application of proper treatment, asthma symptoms can be well controlled. However, the exacerbation of the disease often leads to acute respiratory adverse events that require hospitalization and school absenteeism. In this study, we plan the remote monitoring of lung function parameters in asthmatic children (under 18 years of age). We hypothesize that the daily home monitoring of respiratory indices will predict the occurrence of exacerbation and the hospitalization can be lowered. Asthmatic children arriving for the regular examinations to the Department of Pediatrics and Pediatric Health Care Center of the University of Szeged will be involved. The patients are randomly divided into two treatment groups, telemonitoring and control. For both groups, general patient characteristics will be recorded, and lung function parameters will be measured with a clinical spirometer. Patients in the telemedicine group receive the home mobile controlled spirometer and trained by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months, and children are asked to perform measurements minimum 4 times per week (at least one day a week in the morning and in the evening). In the case of asthma attacks, more frequent measurements repeated several times a day are required. Children in the telemedicine group complete the Asthma Control Test (ACT) after each measurement, which provides a numerical score related to the severity of asthma symptoms. Lung function parameters measured by children and the ACT results are automatically uploaded to a clinical server where the pulmonologists and built-in algorithms are monitoring the quality of the data. In case of deterioration of the lung function parameters, the patients are called for a personal visit and their treatment can be revised. Every three months, members of both groups come to the outpatient clinic for a personal visit, where the same examinations are performed.

Conditions

Asthma in Children; Asthma

Keywords

Spirometry

Outcome Measures

Primary Outcomes (1)

• Incidence of asthma exacerbations per year

  Change of the incidence of asthma exacerbations per year using telespirometry system

  12 months

Secondary Outcomes (6)

• expiratory Forced Vital Capacity (FVC), the maximum amount of air that can forcibly be blown out after full inspiration

  12 months

• Forced Expiratory Volume in one second (FEV1), is the volume of air that can forcibly be blown out in first 1 second after full inspiration

  12 months

• FEV1/FVC ratio (FEV1%)

  12 months

• Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration

  12 months

• Forced Expiratory Flow at 25-75% of FVC (FEF25-75%), mean of forced expiratory flow over the middle half of the FVC

  12 months

Study Arms (2)

Telemedicine arm

EXPERIMENTAL

Device: Inclouded telespirometry system

Control arm

NO INTERVENTION

Interventions

Inclouded telespirometry system DEVICE

Components of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application

Telemedicine arm

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Younger than 18 years
• signed ICF
• asthmatic children with 2-5 GINA score
• The children is open-minded for telespirometric measurements at home and is capable for those measurements
• Parent understands and supports the investigation

You may not qualify if:

• Withdrawal of consent
• Any disease which, by the investigators opinion, is a risk for the patients health and/or is contraindicating the participation in the study
• Bad general condition

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

University of Szeged

Szeged, 6720, Hungary

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Katalin Kapus, MD

CONTACT

+3662545331; kapus.katalin@med.u-szeged.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 25, 2020
• Study Start: June 30, 2020
• Primary Completion: May 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)