Childhood asthma Respiratory
Conditions
Interventions
Current interventions as of 05/06/2025:
1. Intervention (Device Arm): technologically enhanced normal care pathways: Remote wheeze monitoring, using Wheezo AND
remote treatment monitoring, using Prope
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 05/06/2025: 1. Asthma Control Test score <20 within the last 6 months and/or unscheduled healthcare use for asthma (primary or secondary care) within the last 6 months 2. Age between = 6 and < 16 years at enrolment 3. Able to provide informed consent/assent 4. A good command of English in order to use the device apps 5. Access to a smartphone 6. Access to an email address 7. Use of or ability to change to an inhaler compatible with Smart Respiratory smart sensors Previous participant inclusion criteria: 1. Asthma Control Test score < 20 and/or unscheduled healthcare use for asthma (primary or secondary care) within the last 6 months 2. Age between 6 and 16 years at enrolment 3. Able to provide informed consent/assent 4. Access to a smartphone 5. Access to an email address 6. Use of or ability to change to an inhaler compatible with Propeller smart sensors
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 05/06/2025: 1. Participation in other asthma studies with a direct bearing on treatment 2. Patients who have 'opted out of the national data opt-out NHS service' Previous participant exclusion criteria: Participation in other asthma studies with a direct bearing on treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 05/06/2025: Asthma symptom control measured using the asthma control test (ACT) scores among participants at baseline, 6 months, and 12* months. * only for children recruited before 12/24 Previous primary outcome measure: The proportion of participants requiring unscheduled health service use for asthma during the 12-month intervention period measured using parent/patient reporting in a monthly online questionnaire and by extracting data from primary and secondary care health records, where possible | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 05/06/2025: 1. Rates of primary and secondary care health service use, and medicines use during the follow-up period, measured by extracting data from primary and secondary care health records during the 6 and 12*-month intervention period and via patient/parent reporting where appropriate 2. Health-related quality of life, measured using the Pediatric Quality of Life Inventory (PedsQL) at baseline, 6 and 12* months 3. Missed days of school and parental missed days of work, measured using the TEAMCare Healthcare Service Use Information Questionnaire (non-validated) completed monthly during the 6 and 12*-month intervention period 4. User experience of the Wheezo and Propeller technologies, measured by data extracted from qualitative interviews * Only applicable for patients who were randomised before 12/2024 Previous secondary outcome measure: 1. Rates of primary and secondary care health service use, and medicines use during the follow-up period, measured by extracting data from primary and secondary care health records during the 12-month intervention period and via patient/parent reporting where appropriate 2. Children’s health-related quality of life, measured using the Pediatric Quality of Life Inventory (PedsQL) and the Child Health Utility 9 Dimension (CHU-9D) at baseline, 6 months, and 12 months 3. Children’s asthma symptoms, measured using the Asthma Control Test (ACT) at baseline, 6 months, and 12 months 4. Parental wellbeing, measured using the Warwick Edinburgh Mental Wellbeing Score (WEMWS) at baseline,6 and 12 months 5. Children’s wellbeing and mental health, measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline, 6 months, and 12 months 6. Missed days of school and parental missed days of work, measured using the TEAMCare Healthcare Service Use Information Questionnaire (non validated) completed monthly during the 12-month intervention period 7. User experience of the Wheezo and Propeller | — |
Countries
England, United Kingdom
Outcome results
None listed