A cluster Randomised Controlled Trial of the effectiveness, usability and acceptability of a smart inhaler programme in asthma patients: the ACCEPTANCE study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 242

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in medication adherence over twelve months between the smart inhaler programme group and control group measured by electronic monitoring

Secondary Outcome Measures

Name	Time	Method
1. Asthma control (ACQ-5 score) at all time points<br>2. Reliever use (SABA dispense data)<br>3. Asthma-related quality of life (mini-AQLQ score) at all time points<br>4. Exacerbations<br>5. Usability and technology acceptance of the smart inhaler programme from a patient’s and health care professional’s perspective, measured by the System Usability Scale (SUS) and Technology Acceptance Questionnaire (TAQ)<br>6. Use of the smart inhaler programme as measured by log data<br>7. Total costs of health care utilisation <br>8. Absenteeism and presenteeism (WPAI)<br>9. Patient characteristics: attitude and self-efficacy (KASE-AQ), beliefs about medicine (BMQ-S), illness perception (B-IPQ), eHealth Literacy (eHLQ)