Direct Observation Therapy Approach in Children with Asthma V 1.0
Research type
Research Study
Full title
Evaluation of a mobile direct observation therapy (DOT) approach in children and young people with asthma. Pilot study
IRAS ID
161751
Contact name
James McElnay
Contact email
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a pilot study to evaluate any impact of a mobile direct observation therapy (DOT) approach on the use of inhalers by children with asthma who are receiving the usual standard of care in the Asthma Clinic. No alteration to the usual standard of care will be made.
Only children ages 2 to 16 years with asthma that is not well controlled will be invited to participate. The DOT intervention will consist of video monitoring of asthma inhaler use via a mobile technology using a smartphone or similar device in the patient's home. The participant or their parent/guardian will transmit videos of inhaler administration to a repository by using the internet. Researchers will review and evaluate the videos, assessing inhaler technique and adherence with the therapy.
The DOT will occur for 6 weeks, followed by two follow-up assessments at 6 and 12 weeks post-intervention. There are 2 study groups, one receiving the intervention starting at the time of entry to the study, while the intervention will be delayed for 6 weeks of standard care in the other group. Outcomes studied will include the practicality of the mobile DOT intervention, effects of DOT approach on administration technique and adherence to the inhaler use, and any effect of the intervention on disease control and health-related quality of life measurements used in asthma assessment.
The impact of the DOT intervention will be measured by comparison of outcomes immediately after the intervention and at the follow-up evaluations with those measured prior to the intervention. Outcomes between the 2 groups will also be compared.
REC name
HSC REC B
REC reference
14/NI/1099
Date of REC Opinion
5 Nov 2014
REC opinion
Further Information Favourable Opinion