The objective of this study is to assess the clinical effectiveness of the PatientCoach mHealth app with and without home monitoring devices on sustained asthma control after AACT, in patients with severe or uncontrolled asthma.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the time to first exacerbation.
Secondary outcome
Secondary outcomes are total exacerbation rate, asthma control, asthma-related
quality of life, fatigue, depression, health care utilisation, work
productivity and activity impairment, and technology acceptance.
Background summary
Alpine Altitude Climate Treatment (AACT) is used as add-on treatment in severe
uncontrolled asthma. However, upon returning home relapses regularly occur.
Previously, research showed that eHealth support improves long-term outcomes.
The use of home monitoring devices may further sustain long-term asthma
control.
Study objective
The objective of this study is to assess the clinical effectiveness of the
PatientCoach mHealth app with and without home monitoring devices on sustained
asthma control after AACT, in patients with severe or uncontrolled asthma.
Study design
A pragmatic randomized trial with a follow-up of 12 months
Intervention
The use of PatientCoach including home monitoring devices (home spirometer,
Fitbit activity meter, FeNO device)
Study burden and risks
Participants will be provided with an mHealth support app designed as an add-on
to regular care. Therefore no standard care is withheld. Risks for using the
app or the home monitoring devices are negligible. A burden is that
participants are regularly asked to fill in questionnaires. Participants in the
home monitoring group are also asked to use their home monitoring devices and
to copy these values into the app.
Albinusdreef 2 J10-S
Leiden 2333 ZA
NL
Albinusdreef 2 J10-S
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Adult patients with severe asthma who are referred to AACT in the Dutch Asthma
Center Davos. To be eligible for AACT, patients need to have uncontrolled
asthma despite using high doses of inhaled corticosteroids combined with
long-acting bronchodilators for more than 1 year. They have also experienced at
least two severe exacerbations requiring a course of oral corticosteroids
during the past year, or received maintenance oral corticosteroid therapy.
There are no additional eligibility criteria specifically for this study.
Exclusion criteria
Not in possession of a smartphone.
Not being able to read or write.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL75682.058.20 |
| Other | NTR NL9273 |