This study aims to investigate the effectiveness of a smart inhaler based asthma self-management programme on medication adherence in adults with partially controlled or uncontrolled asthma. Secondary objectives are 1) to evaluate the effect of the…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the difference in medication adherence between the
smart inhaler based self-management programme group and the control group over
twelve months as measured by electronic monitoring.
Secondary outcome
Secondary outcomes include asthma control (ACQ-5), asthma-related quality of
life (mini-AQLQ), exacerbations, reliever use, usability and acceptability
(patients and health care professionals), patient characteristics
(self-efficacy, attitude, medication beliefs, illness perception, eHealth
literacy), work productivity (WPAI) and health utilization.
Background summary
Despite the availability of effective treatment, nearly half of the asthma
patients remain sub-optimally controlled. This is mostly due to incorrect
inhaler use or poor medication adherence and leads to unfavourable clinical and
economic outcomes. Smart inhaler based self-management eHealth interventions
have shown promising results in increasing adherence and maintaining asthma
control. However, there is little evidence on the long-term effects and the
usability of such programmes in clinical practice.
Study objective
This study aims to investigate the effectiveness of a smart inhaler based
asthma self-management programme on medication adherence in adults with
partially controlled or uncontrolled asthma. Secondary objectives are 1) to
evaluate the effect of the programme on clinical outcomes (asthma control,
reliever use, number of exacerbations, asthma related quality of life), 2) to
investigate who would benefit most based on patient characteristics, 3) to
evaluate the programme on usability and acceptability by patients and health
care providers (HCPs) and 4) to collect health utilization data to inform a
cost-effectiveness analysis.
Study design
This is an open-label cluster randomized controlled trial of 12 months, which
will be conducted in general practices in the Netherlands. Practices will be
randomly assigned to either the intervention or the control group. We aim to
include 242 patients.
Intervention
Participants in the smart inhaler based self-management programme group will
use an electronic monitoring device attached to their regular maintenance
inhaler, which will be connected to an application on the participant*s
smartphone. The application will give reminders and feedback about the
participants* medication use and participants will be able to document their
asthma symptoms and triggers on a daily basis with a symptom and
trigger-tracking feature. Health care professionals will have access to the
data on medication adherence via a health care portal. Participants in the
control group will be given the electronic monitoring device, which will
objectively monitor their inhalation actuations, without them being able to the
view their medication adherence data or receive reminders (*silent electronic
monitoring*).
Study burden and risks
Participation involves four remote visits. At fixed time points during the
study period, the participants will fill out several questionnaires. The smart
inhaler based self-management programme is not designed to replace HCPs
recommendations. No risks regarding the use of the electronic monitoring device
nor the smart inhaler based self-management programme have been found in
previous studies.
Hippocratespad 21
Leiden 2333ZD
NL
Hippocratespad 21
Leiden 2333ZD
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years;
Doctor-diagnosed asthma (according to Dutch national primary care asthma
guidelines (NHG)) - route A and B; Self-reported asthma diagnosis (confirmed at
study end (T12) by GP) - route C;
Partially controlled or uncontrolled asthma (ACQ >= 0.75);
Use of Symbicort Turbuhaler maintenance therapy;
Being 'non-adherent' defined as an adherence rate (number of fully adherent
days / total number of days) of below 80% over the 3rd and 4th week of the
run-in period.
Exclusion criteria
Use of SMART regimen (Symbicort Maintenance And Reliever Therapy) by taking
Symbicort as reliever in response to symptoms;
Change in inhaled corticosteroids dose in the 4 weeks prior to run-in period;
Use of systemic corticosteroids in the 4 weeks prior to run-in period;
Current use of biologics, (anti-IL-5 en anti-IgE);
Diagnosis of COPD or other significant respiratory diseases;
Malignancy with life expectancy < 1 year;
Pregnancy;
Inability to understand Dutch.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69909.056.19 |
| Other | NL7854 |
| OMON | NL-OMON28450 |