NL-OMON28450
Recruiting
N/A
A cluster Randomised Controlled Trial of the effectiveness, usability and acceptability of a smart inhaler programme in asthma patients: the ACCEPTANCE study
eiden University Medical Center0 sites242 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eiden University Medical Center
- Enrollment
- 242
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Doctor\-diagnosed asthma (when recruited via general practices or public channels), self\-reported asthma diagnosis (when recruited via pharmacies \- asthma diagnosis will be confirmed by GP at study end (T12\))
- •2\. Partially controlled or uncontrolled asthma, defined as an ACQ\-5 score \=0\.75 at the first visit T\-1
- •3\. Use of Symbicort® Turbuhaler® as maintenance therapy for at least eight weeks before entering the run\-in period
- •4\. Being non\-adherent during the run\-in period, defined as an adherence rate of below 80% over the third and fourth week of the run\-in period. Adherence is defined as the number of adherent days as a proportion of the total number of days during the third and fourth week of the run\-in period.
- •5\. In possession of a smartphone
- •6\. Written informed consent
Exclusion Criteria
- •1\. Age \< 18 years
- •2\. Use of SMART regimen (Symbicort Maintenance And Reliever Therapy) by taking Symbicort as reliever in response to symptoms
- •3\. Change in inhaled corticosteroids (ICS) dose in the 4 weeks prior to the run\-in period
- •4\. Use of systemic corticosteroids in the 4 weeks prior to the run\-in period, including maintenance therapy
- •5\. Current use of biologics, including anti\-IL\-5 (mepolizumab, reslizumab, benralizumab) or anti\-IgE (omalizumab)
- •6\. Diagnosis of COPD, interstitial lung diseases, bronchiectasis or other significant respiratory condition
- •7\. Malignancy with life expectancy \< 1 year
- •8\. Pregnancy
- •9\. Inability to understand Dutch
- •10\. Any other condition which, at the GPs and/or investigator’s discretion, is believed may present a safety risk or impact the study results
Outcomes
Primary Outcomes
Not specified
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