A Digital Tool to Help People With COPD Manage Their Condition
Tests a smartphone app with home spirometer in 50 people with COPD.
Plain-language title generated from the registry record
Registry title: Digital Tool for Improved Self-management of COPD
Key facts
- Where
- Solna, SwedenSee the site
Where in Sweden
- KPE Lung and Allergy, QB:84, Karolinska University Hospital.Solna, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Björn Nordlund
- Trial code
- NCT07573098
- Record updated
- 7 May 2026
- Original description
Primary aim: To evaluate the feasibility, usability and safety of the investigational device in clinical practice over 6 months in 50 patients.Read full original descriptionShow less
Digital Tool for Improved Self-management of COPD
Primary aim: To evaluate the feasibility, usability and safety of the investigational device in clinical practice over 6 months in 50 patients.
Secondary aims: To describe the number of healthcare contacts and the adequacy of those contacts.
Study design: Traditional feasibility clinical investigationPilot feasibility open observational study.
Subjects: 50 subjects being investigated for or with a diagnosis of COPD with at least one exacerbation within the last year will be invited to voluntarily participate. Exclusion criteria is severe disease from either COPD or any severe concomitant conditions that would make home spirometry unsafe for the patient. Patients with no access to use BankID or similar electronic personal identification service and not using Android (version 8+) or iOS (version 16+) smartphones will be excluded.
Intervention: At inclusion patients will be on-boarded on to the digital platform and recommended to follow instructions in the app. The intervention is the COPD Treatment check, which is a medical device that is connected to a spirometer. Patients will be instructed to self-test on a daily basis.
Control group: There will be no control group.
Primary endpoints:
• Feasability and usability of the system in a clinical setting as determined by usage and questionnaire evaluation. Feasibility measured by proportion of participants who complete the study, compliance and adoption (system usage), time needed to train users
Secondary endpoints:
* Safety of the device
- Experienced usability and the number of adverse events * Adequacy of the participant's healthcare contacts.
* Number of actual clinic contacts in relation to the number of recommendations by the COPD treatment check to seek medical attention. Exacerbations (as defined by healthcare staff) * Evaluation of questionnaires (healthcare and patient reported)
Inclusion: Subjects from the age of 40 years with documented diagnosis of COPD, using at least two inhaled medications (one combination inhaler or several inhalers), and with at least one exacerbation within the last year will be invited to voluntarily participate.
Exclusion: Exclusion criteria is severe disease from either COPD or any severe concomitant conditions that would make home spirometry unsafe for the patient. Patients with no access to use BankID or similar electronic personal identification service and not using smartphones will be excluded. Also, individuals who are pregnant or breastfeeding women, and individuals who are unable to provide informed consent due to cognitive impairment or other reasons indicating lack of decision-making capacity will be excluded.