N/A
Completed N=35
Novel Electronic Monitoring Devices (NEMD) to Monitor Adherence in Children With Asthma
Source: ClinicalTrials.gov NCT04289714 ↗Enrolled (actual)
35
Serious AEs
—
Results posted
Oct 2020
Primary outcomePrimary: Acceptability Using Semi Structured Questionnaires in Focus Groups and Interviews — 7; 4; 3 Participants
Summary
This is a feasibility study to assess novel electronic monitoring devices for monitoring adherence in children with asthma who are on inhaled corticosteroids (ICS)
It is a mixed method (quantitative and qualitative) open label, pragmatic randomised feasibility study with two main aims:
1. To assess the feasibility of 4 novel electronic monitoring devices in children aged 6-16 years with asthma, in terms of usability and acceptability by patients/ guardians and healthcare professionals (qualitative study)
2. To evaluate the accuracy of these devices and assess whether they impact on asthma control (quantitative study).
The duration of study is 16 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability Using Semi Structured Questionnaires in Focus Groups and Interviews |
7; 4; 3 | — |
| PRIMARY Number of Themes Generated by Participants Regarding Usage of the Devices |
4; 4; 4 | — |
| SECONDARY Adherence to Inhaled Medication |
72; 65; 87 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained from parents/guardian/adolescents and/or assent from the child.
- Children aged between 6-16 years with a diagnosis of asthma attending the Royal Brompton and Harefield Difficult asthma clinic.
- Children on inhaled cortico-steroids
- Parents/ young person has a mobile phone which can download apps
- Paediatric respiratory nurses working in the difficult asthma team at Royal Brompton Hospital.
Exclusion Criteria
- Unable to provide consent
- As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
- Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures
- Children under the age of 6 years.
- Children not on inhaled cortico-steroid
- It is not anticipated that any children will be pregnant, however, if they are they will not be included in the study
Data sourced from ClinicalTrials.gov (NCT04289714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.