Novel electronic monitoring devices to monitor adherence in asthma
Research type
Research Study
Full title
A feasibility study to assess Novel Electronic Monitoring Devices (NEDM) for monitoring adherence in children with asthma
IRAS ID
239759
Contact name
Louise Fleming
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Most children in the UK diagnosed with asthma will achieve good control if low dose inhaled corticosteroids are regularly and correctly administered. However, a significant proportion have their treatment increased due to ongoing symptoms and asthma attacks. The National review of Asthma Deaths highlighted that there was poor recognition of these outcomes, particularly in children.
Poor adherence is the single most important reason for apparent treatment failure, however, this is often not considered or addressed.
To address these issues, electronic monitoring devices (EMDs) which record each activation of inhaled medication have been utilised to attempt to improve adherence. EMDs enable healthcare professionals to monitor adherence and guide decision making in treatment and aid patient self - management and improve adherence.
Of fundamental importance is that EMDs used in current studies in children measured activation and not inhalation and therefore devices could have been manipulated and not measured poor technique.
A short term EMD study in children with asthma suggested that only 20% of children labelled as ‘problematic severe asthma’ had on going poor control despite having good adherence.
Our study will investigate the feasibility of four novel electronic monitoring devices (NEMD) currently available which use techniques of inhalation and activation to monitor technique and adherence, assessing the usability, acceptability and perceived accuracy of each device.
We plan to randomly allocate children to one of three groups, matched for age to trial these devices.
We will conduct a period of up to 16 weeks of home monitoring using these NEMDs and carry out focus group or individual interviews to determine which device would be the most acceptable and easy to use by parents/guardian/patients and healthcare professionals.
We will download the data from the devices to check for accuracy.
Additionally, we will carry out routine clinical care monitoring such as asthma control test (ACT)to assess the impact on asthma control.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0923
Date of REC Opinion
28 Jun 2018
REC opinion
Further Information Favourable Opinion