Digital Prevention of Asthma

NCT04132778 | Terminated DMC

• 1 other identifier: v.10
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma; Care Management, Patient

Keywords

Asthma; AsthmaTuner; Management

Outcome Measures

Primary Outcomes (1)

• Symptom control

  Mean score of Asthma Control Test, e-questionnaire will be sent to participants to fill in.

  By 6 months

Secondary Outcomes (3)

• Exacerbations

  Up to 6 months

• Adherence

  Up to 6 months

• Lung function

  Up to 12 months, singel arm, only patients allocated to the intervention

Study Arms (2)

Intervention - Asthmatuner

EXPERIMENTAL

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.

Device: AsthmaTuner

Control group - Traditional asthma management

NO INTERVENTION

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.

Interventions

AsthmaTuner DEVICE

Conventional treatment was defined as non-digital self-management using paper individual treatment plans, which contained treatment adjustments of prescribed medications according to symptoms of controlled, partly controlled or uncontrolled asthma, along with instructions according to national guidelines.

Also known as: Digital Automated self-management

Intervention - Asthmatuner

Eligibility Criteria

• Age: 6 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Doctors diagnosed asthma

You may not qualify if:

• Presence of comorbidity with significant impact on symptom control

Sponsors & Collaborators

• Karolinska Institutet: lead
• Tiohundra AB: collaborator
• Karolinska University Hospital: collaborator

Study Sites (2)

Healthcare region Tiohundra

Norrtälje, Sweden

Location

Astrid Lindgren Children's Hospital

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Physician blinded to the allcocated treatment; AsthmaTuner or traditional treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research group leader, co-founder of the investigational product, PhD and RN

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 21, 2019
• Study Start: October 14, 2019
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 26, 2025

Record last verified: 2023-02

Locations

SE (2)