Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT07573098

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

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

KPE Lung and Allergy, QB:84, Karolinska University Hospital.

Solna, Stockholm County, Sweden, 17164

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here