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This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correct/recheck strategy | Experimental | Patients of study arm will be asked to show how they use their two inhalers and identify errors using a device-specific checklist by research assistant. Research assistant then show the patient how to use these devices correctly and give the checklist including the steps patients did wrong. After teaching by the research assistant, patients were asked to demonstrate the correct way of wrong step(s) they made at beginning. |
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| Usual verbal instruction | Active Comparator | Patients of control arm will be asked to show how thy use their two inhalers and identify errors using specific check list by research assistant. The educational nurse will give verbal instruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Correct/recheck strategy | Other | One month after recruitment and every 3 months. 1. Check the inhaler step errors of patients by research assistant; 2.Demonstrate the right way by research assistant; 3. give the inhaler check list with marks of the wrong step(s) patients made to patients and 4. confirm the patients do the right way of the previous wrong step(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Errors rate of Inhaler steps | The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control | The improvement of asthma control evaluated by Asthma Control Test (ACT). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | 3 months |
| Asthma control |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the errors rate of Inhaler steps and mini-cog score | The mini-cog score will be evaluated when patient recruitment. The mini-cog is score of five-points in total, a score of zero, one or two indicates a concern in cognitive functioning. The error of inhaler steps will be recorded one month after 3 month of add-on tiotropium and ICS+LABA. Correlation will be tested via Pearson's test or Sperman rank correlation test. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting-Yu Lin | Chest department, Chang-Gung Memorial Hospital, Linkou branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Medicine, Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
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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 |
|---|---|
| C038509 | docusate sodium mixt. with phenolphtalein |
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Brief summary of protocol At visit 1, patients characteristics, lung function, cognition function, HRV, CRC and FeNo will be recorded. Randomization by stratification with cognition function will be done but both arms receive usual verbal instruction of inhaler steps.
At visit 2, inhaler step errors will be recorded 1 months after add-on Tiotropium with ICS+LABA and interventions of education start by correct/recheck strategy in study arm and usual verbal instruction in control arm.
At visit 3, inhaler step errors will be recorded 3 months after add-on Tiotropium with ICS+LABA as the primary endpoint. Heart rate variability (HRV), cardiopulmonary coupling (CRC) and FeNo will be checked.
Other endpoints, e.g. lung function, PEFR, exacerbation will be evaluated at V3 and V4 (6 months after V1), V5 (9 months after V1) and V6 (12month after V1)
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The subjects enrolled will be informed the purpose of this study is to evaluate the inhaler step errors after add-on tiotropium with the other ICS+LABA inhaler and how the education improve patients to reduce the error rate. The subjects are not aware the different methods of study arm and control arm.
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| Usual verbal instruction | Other | One month after recruitment and every 3 months.1. Check the inhaler step errors of patients by research assistant; 2. Verbal instruction with a physical demonstration will be given by educational nurse in usual care. |
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The improvement of asthma control evaluated by Asthma Control Questionnaire-7 (ACQ-7). ACQ-7 is 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) |
| 3 months |
| Forced expiratory volume in one second (FEV1) before bronchodilation | The improvement of FEV1 before bronchodilation evaluated by spirometry after 3 month of add-on tiotropium and ICS+LABA | 3 months |
| Acute exacerbation | The rate of acute exacerbation in one year | 3, 6,9 and 12 month |
| 1 month |
| Correlation of the errors rate of Inhaler steps and poor asthma control | The error of inhaler steps will be recorded one month after add-on tiotropium therapy. Asthma control will be evaluated by Asthma Control Test (ACT) 3 months after 3 month of add-on tiotropium and ICS+LABA. Correlation will be tested via Pearson's test or Sperman rank correlation test. The distribution of errors rate of inhaler steps between patients with asthma well control (ACT>19) and patients with asthma poor control (ACT<=19) will be tested by Mann-Whitney test. | 3 month |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |