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The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Other | Control experience using marketed application to record medication intake without reminders from the app |
|
| Intervention | Experimental | Full experience using marketed application, with all functionalities enabled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed experience application on adherence | Behavioral | To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in adherence rate to entire treatment period | Adherence Rate of doses correctly taken twice daily | From baseline to end of participation (up to 3 months) |
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| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test score | Change from Baseline | From baseline to end of participation (up to 3 months) |
| Test of the Adherence to Inhalers score | Change from Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annaliese Linnhoff | Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barlow Medical Centre | Manchester | M20 2RN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35691614 | Derived | Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2. |
| Label | URL |
|---|---|
| Structured Summary Data Results on Chiesi Clinical Study Register | View source |
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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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| From baseline to end of participation (up to 3 months) |
| Percentage of days without intake of rescue medication | Change from Baseline | From baseline to end of participation (up to 3 months) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |