Actively Recruiting
Digital Tool for Improved Self-management of COPD
Led by Björn Nordlund · Updated on 2026-05-07
50
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Digital Tool for Improved Self-management of COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Documented diagnosis of COPD
- Use of at least two inhaled medications (one combination inhaler or multiple inhalers)
- At least one exacerbation within the last year
You will not qualify if you...
- Severe COPD or severe other health conditions making home spirometry unsafe
- No access to BankID or similar electronic identification service
- Not using an Android smartphone (version 8+) or iOS smartphone (version 16+)
- Pregnant or breastfeeding women
- Unable to provide informed consent due to cognitive impairment or lack of decision-making capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
KPE Lung and Allergy, QB:84, Karolinska University Hospital.
Solna, Stockholm County, Sweden, 17164
Actively Recruiting
Research Team
H
Henrik Ljungberg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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