A Novel Digital Self-management System Targeting Automated Prevention of Asthma

Status: Terminated
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Asthma self-management is dependent on support and education. To facilitate self-management have we developed and CE-mark a novel digital self-management system called Asthmatuner (Medituner AB, Sweden).The primary aim of this program is to evaluate if self-management with Asthmatuner improves asthma control more than traditional self-management. RCT with two arms, Asthmatuner or traditional asthma management, during at least 6 months. Thereafter, the study continues to be observational from 6- 12 months. Eligible patients with doctor's diagnosed asthma that are managed within the municipality of Tiohundra and Astrid Lindgren Children's Hospital will be invited to participate. Approximately 800 patients, adults and schoolchildren of the age of 6 years will be recruited.Outcomes: Asthma Control Test, number of exacerbations, unplanned healthcare visits, Medicine Adherence Report Scale and lung function.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 99
Healthy Volunteers: f
View:

• Doctors diagnosed asthma

Locations
Other Locations
Sweden
Healthcare region Tiohundra
Norrtälje
Astrid Lindgren Children's Hospital
Stockholm
Time Frame
Start Date: 2019-10-14
Completion Date: 2024-12-01
Participants
Target number of participants: 331
Treatments
Experimental: Intervention - Asthmatuner
Asthmatuner (Medituner AB, Stockholm, Sweden) is a CE-marked cloud-computing-based system with a healthcare interface and a downloadable patient app (Android or iOS).The intended use of Asthmatuner is to automate asthma self-management by letting patients register symptoms and measure forced expiratory volume in one second (FEV1) with a Bluetooth spirometer (MIR, SmartOne). The patient then receives immediate feedback on the status of symptom control (controlled, partly controlled or uncontrolled), and a treatment recommendation, with an image of the correct inhaler or other type of medication and the dose. Symptom control is quantified based on lung function; litre to percentage of personalised best FEV1, using a cut-off ≤80% and symptoms during the last week based on four questions: 1) need for rescue medication more than twice due to asthma symptoms, 2) any daytime symptoms, 3) nocturnal symptoms/awakenings, and 4) limitation in physical activities.
No_intervention: Control group - Traditional asthma management
Traditional self-management is defined as all other types of non-digital asthma management. This could be treatment plan written on paper or by oral communication to patient/caregiver on asthma treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Tiohundra AB, Karolinska University Hospital
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov