Remote Monitoring of Asthma in Children and Young People
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorUniversity of Edinburgh
About this trial
The objective of this study is to determine whether healthcare data and remotely collected patient data can accurately predict asthma attacks in children and young people aged 5-17 years. The main outcome is:
when using this new system, is there a reduction in asthma attacks compared with a historic average.
The whole population of children and young people with asthma will have routine healthcare data monitored, with a subset of people with high risk asthma asked to participate in a more detail study involving remotely monitored data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and Young People with a diagnosis of asthma (coded as asthma or suspected asthma) or a prescription of inhaled corticosteroid in the prior 2 years.
Disqualifiers
Alternative non-asthma diagnosis that would require inhaled steroid
cystic fibrosis
bronchiectasis
primary ciliary dyskinaesia
Trial population
The whole population of those with asthma from an individual primary care cluster within NHS Lothian.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
900 Participants
are grouped into 2 trial groupsGroup A: Whole population with asthma within a single primary care cluster
Group B: Subset of this cohort, identified as being at high risk of an asthma attack
Trial outcomes
Primary outcomes
1
Number of asthma attacks
Change in primary care prescriptions for asthma attack medication (Prednisolone or similar) in the population utilising this new system compared with a historical asthma population from the same location.
Time frame
6 monthsSecondary outcomes
1
Number identified as high risk
Number of individuals flagged each week by the novel risk algorithm.
Time frame
6 months2
Rate of symptoms reported
Improvements in reported symptoms for patients using the app during the study period.
Time frame
6 months3
Interventions required
Types of interventions required for those at high risk - e.g. phone call, face to face primary care review, hospital clinic appointment
Time frame
6 months4
Number of hospital asthma attacks
Change in asthma attacks (ED and hospital admissions) in the population using the new clinical system, compared with historical asthma admission rates.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov