Digital Tool for Improved Self-management of COPD (FOCUS)

May 4, 2026 updated by: Björn Nordlund

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patient "education" often takes the form of providers giving didactic Information and assumes that knowledge will lead to behavioural change. Although important, it may not be sufficient for promoting self-management skills. Enhancing patient knowledge is an important step towards behaviour change using self-management interventions and should include topics such as smoking cessation, correct use of inhaler devices, early recognition of exacerbations, decision-making and acting at the right time, and when to seek help. Personalized education and training that takes into account specific issues relating to the individual patient, and that aims to enhance long-term functionality and appropriate health behaviours are likely to benefit patients more. A good COPD self-management intervention is structured but personalized, with goals of motivating, engaging and supporting the patients to positively adapt their health behaviour(s) and develop skills to better manage their disease. The aim is to elicit patient motivation, confidence and competence. Systematic reviews have provided evidence that self-management interventions improve outcomes in COPD. A 2022 Cochrane review reported that interventions for people with COPD are associated with improvements in health-related quality of life (HRQoL), a lower probability of respiratory-related hospital admissions, and no excess respiratory-related and all-cause mortality risks.

One of the most important goals for treatment of COPD exacerbations are to minimize the negative impact of an exacerbation and to prevent subsequent events. Also, it is now recognized that many exacerbations are not reported to healthcare professionals for therapy and yet these events have a significant impact on health status. Thus, one focus is for COPD patients to receive education about the importance of understanding exacerbation symptoms and when to seek professional healthcare.

According to the Swedish National Board of Health and Welfare a written self-management plan should be established together with the healthcare team and be reevaluated at follow-up visits. The plan should contain information on how to adjust treatment according to for example symptoms and infections, and when it is important for the patient to contact healthcare for assistance.

The investigational device is a separate module, COPD Treatment check, embedded in the cloud-based CE-marked system called AsthmaTuner. Our hypothesis is that this digital tool will improve self-management of COPD. Thus, the aim of this study is to assess the feasibility, usability and safety of the COPD Treatment check in clinical practice. Secondary aim is to evaluate the number of healthcare contacts and the adequacy of those contacts.

At baseline, a trained nurse will onboard and instruct patients in device handling (standard education). According to a flow algorithm, the app will instruct patients to contact their healthcare provider. The healthcare provider will be able to see collected data that is displayed in the back-end system but will not be instructed to actively monitor patients.

Data on feasibility, safety and experienced usability of the investigational device will be presented. The analysis of feasibility and the experienced benefit of using the COPD Treatment check in clinical practice is estimated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree), and presented as mean and median scores. The number of clinic contacts will be presented in relation to the number of times that the app has recommended such contacts. A medical doctor will categorize the contacts as correct or incorrect, without knowing whether the contacts were initiated via the app or the patient themselves to avoid bias.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 17164
        • Recruiting
        • KPE Lung and Allergy, QB:84, Karolinska University Hospital.
        • Contact:
          • Björn Nordlund Sponsor and Investigator, PhD, Associate Professor
          • Phone Number: 0046703234414
          • Email: bjorn.nordlund@ki.se

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COPD treatment check
At inclusion patients will be onboarded 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.
Device: COPD treatment check
The investigational device is designed to support self-management of COPD. It provided patients with remote individualized feedback and recommendations for symptom relief and exacerbation management based on actual lung function and symptom report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of participants that perceives the device feasible to use.
Time Frame: 6 months
Feasability of the system in a clinical setting as determined by usage and questionnaire evaluation.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of the participant's healthcare contacts and adverse events.
Time Frame: 6 months
Number of actual clinic contacts in relation to the number of recommendations by the COPD treatment check to seek medical attention. Adverse events listed in agreement with the Clinical Investigation Plan version 5.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Björn Nordlund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

May 5, 2027

Study Completion (Estimated)

May 5, 2027

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-24-12-050346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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