Asthma, Asthma in Children
Conditions
Keywords
asthma, asthma control, respiratory management platform, medical device, inhaler technique
Brief summary
This randomised, prospective, controlled parallel study aims to evaluate the role and potential of the aflo™ digital platform for improving asthma control, inhalation technique and adherence in patients who use metred dose inhalers (MDI). The study will recruit 104 patients with uncontrolled asthma in the North-West of Northern Ireland. Fifty two patients will remain on standard care over 24-weeks and 52 will combine standard care with the aflo™ platform. The data collected over a 24-week period will be used to determine 1. whether the aflo™platform improves inhalation technique and user adherence to prescribed medication and 2. Lead to better asthma control and reduced symptoms as measured by the Asthma Control Test (ACT). During the study clinicians will be able to remotely monitor and review user analytics via a clinical dashboard. ACT measurements will be recorded at start and end of study. The study aims to test the functionality and impact of automated inhaler technique with real-time feedback, adherence prompts and air quality data sharing for patients who use metered dose inhalers (MDI) using the newly developed aflo™ digital respiratory management platform.
Interventions
DEVICEaflo™ digital respiratory management platform
medical device, user app, clinician portal, data analytics hub
OTHERStandard care
Health service standard care will be continued
Sponsors
Northern Ireland Clinical Research Service
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Independent allocation, no masking.
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Confirmed as suitable for inclusion by their General Practitioner or asthma nurse. * Access to WiFi and a smart phone (Android or apple phone with latest version -2) and knowledge of / carer support with using a smartphone. * For children (parent/ carer must register and provide smart phone access) * Aged \> 5 years (with carer/ parental consent if \< 17 years old) * Smart phone user/ willing to use (or parent/ carer) and have access to and knowledge of working a smart phone and WIFI / 4G * Currently prescribed an inhaled reliever +/- preventer medication via pressurised * Metered Dose Inhaler (MDI) short acting beta2 agonist (SABA), inhaled corticosteroid (ICS) ICS / long acting beta2 agonist (LABA) MDI +/- spacer * Adherence/ symptom control issues with medication (as identified by excess use of SABA/ healthcare personnel visits/ calls/ emergency department visit/ hospital admission * Those who understand written and spoken English
Exclusion criteria
* \< 5 years old * Other major respiratory illness or significant concurrent disease that might prevent completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inhaler Proficiency checklist Score (IPS) | Change over 24 weeks | Inhalation score 0-7 (higher the score the greater the proficiency) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health impairment in asthma patients | Change over 24 weeks | Measured by St George's Respiratory Questionnaire (SGRQ).(0: best health; 100: worse health) |
| Inflammation | Change over 24 weeks | Blood immunoglobulin E (IgE) (microarray) |
| Exhaled breath nitric oxide (FeNO) | Change over 24 weeks | Measured by a FeNO monitoring system |
| Asthma health and symptoms questionnaire | Change over 24 weeks | Number of hospital visits, number of attacks (the higher number the more negative the outcome). |
| Asthma control | Change over 24 weeks | Asthma Control Test (ACT) (0-25 with a score \<20: uncontrolled; 20-24: reasonably well controlled; 25: controlled) |
| Medication usage | Change over 24 weeks | Usage of asthma medication: increased usage of 'preventer' inhaler and decreased use of salbutamol/' reliever' inhaler |
| Lung function | Change over 24 weeks | Lung volume / capacity measured by a spirometer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | At 24 weeks | Evaluation of device (4-point scale; higher score the more satisfied) |
| Qualitative feedback | Baseline, 12 weeks and 24 weeks | Unstructured open-ended feedback |
| Device feedback | Baseline, 12 weeks and 24 weeks | Functionality of device (4-point scale; higher score the more satisfied) |
Countries
United Kingdom
Contacts
Primary ContactRuth Karen Price
Backup ContactJulie Sittlington
Outcome results
None listed