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| Name | Class |
|---|---|
| Northern Ireland Clinical Research Service | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator |
| |
| aflo™ digital respiratory management platform with standard care | Experimental | The new aflo™ digital respiratory management platform will provide automated inhaler technique direction, with real time quantitative personalised feedback on inhaler technique and timing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflo™ digital respiratory management platform | Device | medical device, user app, clinician portal, data analytics hub |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhaler Proficiency checklist Score (IPS) | Inhalation score 0-7 (higher the score the greater the proficiency) | Change over 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control | Asthma Control Test (ACT) (0-25 with a score <20: uncontrolled; 20-24: reasonably well controlled; 25: controlled) | Change over 24 weeks |
| Medication usage | Usage of asthma medication: increased usage of 'preventer' inhaler and decreased use of salbutamol/' reliever' inhaler |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Evaluation of device (4-point scale; higher score the more satisfied) | At 24 weeks |
| Device feedback | Functionality of device (4-point scale; higher score the more satisfied) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Karen Price | Contact | 02870123878 | rk.price@ulster.ac.uk | |
| Julie Sittlington | Contact | +442870124101 | jj.sittlington@ulster.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit | Recruiting | Coleraine | N.Ireland | BT52 1SA | United Kingdom |
Commercially sensitive
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Independent allocation, no masking.
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| Standard care | Other | Health service standard care will be continued |
|
| Change over 24 weeks |
| Health impairment in asthma patients | Measured by St George's Respiratory Questionnaire (SGRQ).(0: best health; 100: worse health) | Change over 24 weeks |
| Lung function | Lung volume / capacity measured by a spirometer | Change over 24 weeks |
| Lung function | Lung rates of flow measured by a spirometer | Change over 24 weeks |
| Lung function | Lung gas exchange measured by a spirometer | Change over 24 weeks |
| Inflammation | Blood immunoglobulin E (IgE) (microarray) | Change over 24 weeks |
| Inflammation | Blood eosinophils (Sysmex full blood count) | Change over 24 weeks |
| Exhaled breath nitric oxide (FeNO) | Measured by a FeNO monitoring system | Change over 24 weeks |
| Asthma health and symptoms questionnaire | Number of hospital visits, number of attacks (the higher number the more negative the outcome). | Change over 24 weeks |
| Baseline, 12 weeks and 24 weeks |
| Qualitative feedback | Unstructured open-ended feedback | Baseline, 12 weeks and 24 weeks |
| Health Hub Professionals | Recruiting | Londonderry | N.Ireland | BT48 0LU | United Kingdom |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |