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COPDFOCUSNCT07573098

Digital Tool for Improved Self-management of COPD

A study testing COPD treatment check in people with COPD, run by Björn Nordlund at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
COPD treatment check
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSweden
Study dates
5 Dec 2025to 5 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Henrik Ljungberg contact

+46706628642

henrik.ljungberg@ki.se

Sweden1 site, 1 recruiting
  • KPE Lung and Allergy, QB:84, Karolinska University Hospital.

    Solna, Stockholm County, 17164

    Björn Nordlund Sponsor and Investigator, PhD, Associate Professor, 0046703234414, bjorn.nordlund@ki.se

    Recruiting

Other trials in Sweden

About this study

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.

Read more

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)
Read the 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.

Conditions
COPD
Being tested
COPD treatment check
Keywords
Self-management, Digital technology
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COPD treatment checkDevice

    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.

Study groups in NCT07573098
Study groupRoleWhat they receive
COPD treatment checkExperimentalAt 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.
Receives: Device: COPD treatment check

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of participants that perceives the device feasible to use.

    Feasability of the system in a clinical setting as determined by usage and questionnaire evaluation.

    Measured: 6 months

Secondary outcomes (1)
  1. Adequacy of the participant's healthcare contacts and adverse events.

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start5 Dec 2025
  3. Primary completion5 May 2027 (estimated)
  4. Study completion5 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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. Decreasing lung function or increased symptoms will lead to a recommendation to contact healthcare.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573098
Sponsor's protocol ID
CIV-24-12-050346
Acronym
FOCUS
Status last verified
May 2026
First submitted
5 Dec 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Breckner A, Roth C, Glassen K, Wensing M. Self-management perspectives of elderly patients with multimorbidity and practitioners - status, challenges and further support needed? BMC Fam Pract. 2021 Nov 26;22(1):238. doi: 10.1186/s12875-021-01584-9.

    PubMed 34836506
  • Human D, Crawley F, IJesselmuiden C. Revised declaration of Helsinki. WMA will continue to revise policy as medicine and research changes. BMJ. 2001 Aug 4;323(7307):283-4. No abstract available.

    PubMed 11505938
  • Williams V, Price J, Hardinge M, Tarassenko L, Farmer A. Using a mobile health application to support self-management in COPD: a qualitative study. Br J Gen Pract. 2014 Jul;64(624):e392-400. doi: 10.3399/bjgp14X680473.

    PubMed 24982491
  • Chau JP, Lee DT, Yu DS, Chow AY, Yu WC, Chair SY, Lai AS, Chick YL. A feasibility study to investigate the acceptability and potential effectiveness of a telecare service for older people with chronic obstructive pulmonary disease. Int J Med Inform. 2012 Oct;81(10):674-82. doi: 10.1016/j.ijmedinf.2012.06.003. Epub 2012 Jul 11.

    PubMed 22789911
  • Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.

    PubMed 22743675
  • Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

    PubMed 16055882
  • Schoultz K, Svensson A, Emilsson M. Nurses' experiences of using AsthmaTuner - an eHealth self-management system for healthcare of patients with asthma. Digit Health. 2022 Apr 11;8:20552076221092542. doi: 10.1177/20552076221092542. eCollection 2022 Jan-Dec.

    PubMed 35433019
  • Ljungberg H, Carleborg A, Gerber H, Ofverstrom C, Wolodarski J, Menshi F, Engdahl M, Eduards M, Nordlund B. Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial. Eur Respir J. 2019 Nov 14;54(5):1900983. doi: 10.1183/13993003.00983-2019. Print 2019 Nov.

    PubMed 31481605
  • Regions, S.A.o.L.A.a., Treatment plan COPD. https://registercentrum.blob.core.windows.net/lvr/r/KOL-Min-behandlingsplan-S1g1JxirfL.pdf, 2024 Dec.

  • Welfare, S.N.B.o.H.a., Performance assessment of asthma and COPD healthcare. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/nationella-riktlinjer/2018-12-44-eng.pdf, 2018.

  • Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27.

    PubMed 14990395
  • Schrijver J, Lenferink A, Brusse-Keizer M, Zwerink M, van der Valk PD, van der Palen J, Effing TW. Self-management interventions for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD002990. doi: 10.1002/14651858.CD002990.pub4.

    PubMed 35001366
  • Effing TW, Vercoulen JH, Bourbeau J, Trappenburg J, Lenferink A, Cafarella P, Coultas D, Meek P, van der Valk P, Bischoff EW, Bucknall C, Dewan NA, Early F, Fan V, Frith P, Janssen DJ, Mitchell K, Morgan M, Nici L, Patel I, Walters H, Rice KL, Singh S, Zuwallack R, Benzo R, Goldstein R, Partridge MR, van der Palen J. Definition of a COPD self-management intervention: International Expert Group consensus. Eur Respir J. 2016 Jul;48(1):46-54. doi: 10.1183/13993003.00025-2016. Epub 2016 Apr 13.

    PubMed 27076595
  • Riley CM, Sciurba FC. Diagnosis and Outpatient Management of Chronic Obstructive Pulmonary Disease: A Review. JAMA. 2019 Feb 26;321(8):786-797. doi: 10.1001/jama.2019.0131.

    PubMed 30806700
  • Cravo A, Attar D, Freeman D, Holmes S, Ip L, Singh SJ. The Importance of Self-Management in the Context of Personalized Care in COPD. Int J Chron Obstruct Pulmon Dis. 2022 Jan 22;17:231-243. doi: 10.2147/COPD.S343108. eCollection 2022.

    PubMed 35095272

Questions about this trial

What is this clinical trial studying?

A study testing COPD treatment check in people with COPD, run by Björn Nordlund at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Henrik Ljungberg (+46706628642, henrik.ljungberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of participants that perceives the device feasible to use. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07573098, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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