|- candidate number||26701|
|- NTR Number||NTR6234|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-feb-2017|
|- Secondary IDs||NL59878.044.16 MEC number|
|- Public Title||Wearable technology to assess children’s asthma control in the home-situation|
|- Scientific Title||Wearable technology to assess children’s asthma control in the home-situation|
|- hypothesis||Home monitoring of asthma symptoms could be used to provide the physician with more insight into the current asthma status and provide an opportunity to anticipate into the episodically waves of asthma. Therefore this research will focus on home monitoring of asthmatic children with the use of wearable technology. |
It is hypothesized that asthma control can be accurately determined with home measured signals of the wearables.
|- Healt Condition(s) or Problem(s) studied||Asthma, Bronchial hyperresponsiveness, Children|
|- Inclusion criteria||Phase 1 (60 patients): |
• Children with paediatric based asthma.
• Children aged between 4 and 14 years old.
• Children that receive an ECT.
Phase 2 (30 healthy controls):
• Healthy children aged between 4 and 14 years old.
|- Exclusion criteria||Both phase 1 and phase 2:|
• Children with an inability to understand or speak Dutch. This also applies for the parents of all children below the age of 12.
• Children with a pacemaker / implantable cardioverter-defibrillator (ICD) or other electrical stimulation device.
• Children for whom it is not possible to wear all wearables. For example due to severe skin diseases or amputation of the arms etc.
• Children with psychomotor retardation.
• Children with chronic diseases (other than asthma).
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-dec-2017|
|- Target number of participants||90|
|- Interventions||*The use of 4 wearables. ECG recorder, activity tracker, smart inhaler and spirometer for 2 weeks.|
*3 questionnaires at the end of each monitoring week. (C-ACT, PAQ-C, PAQLQ)
*Single bio-impedance scale measurement and exhaled breath measurement.
|- Primary outcome||The primary endpoint of this study is the asthma control. This categorical variable will be tested for its agreement with the measured home-measured parameters. |
|- Secondary outcome||*Accuracy and reproducibility of the wearable devices.|
*Asthma severity in non controlled asthma patients and its relation to the wearable data.
*Patient perception of asthma control.
*The agreement of the Exhaled biomarker measurement with asthma control.
|- Timepoints||Every week 3-4 patients are asked to participate. |
These patient were recruited based on the already clinically scheduled asthma patient for an exercise challenge test (ECT).
-4 weeks before ECT: recruitment of patients.
-3 weeks before ECT: informed consent.
-2 weeks before ECT: instruction and start using wearables.
-0 weeks before ECT: exercise challenge test.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||BSc M.R. van der Kamp|
|- CONTACT for SCIENTIFIC QUERIES||Dr. B.J. Thio|
|- Sponsor/Initiator ||MST Enschede|
(Source(s) of Monetary or Material Support)
|Stichting Pediatrisch Onderzoek Enschede|
|- Publications||No publications yet. |
|- Brief summary||Asthma is a chronic disease with a high prevalence and high health care costs. Pediatric asthma management is focused on control of asthma symptoms, enabling patients to fully participate in daily life. However, monitoring pediatric asthma is challenging as symptoms are episodic and therefore often absent during clinical visitation. Additionally, children’s expression of asthma symptoms is often difficult to assess and interpret. |
Home monitoring of asthma symptoms could be used to provide the physician with more insight into the current asthma status and provide an opportunity to anticipate into the episodically waves of asthma. Therefore this research will focus on home monitoring of asthmatic children with the use of wearable technology.
In this study it will be investigated whether the home measured wearable signals could accurately predict a child's asthma control, compared to the current clinical standard (the exercise challenge test).
|- Main changes (audit trail)|
|- RECORD||14-feb-2017 - 12-apr-2017|