Digital Tool for Improved Self-management of COPD

NCT07573098 | Recruiting DMC

• 1 other identifier: CIV-24-12-050346
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

COPD

Keywords

Self-management; Digital technology

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (1)

• Adequacy of the participant's healthcare contacts and adverse events.

  6 months

Study Arms (1)

COPD treatment check

EXPERIMENTAL

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

Interventions

COPD treatment check DEVICE

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.

COPD treatment check

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Björn Nordlund: lead

Study Sites (1)

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

Solna, Stockholm County, 17164, Sweden

RECRUITING

Related Publications (27)

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  BACKGROUND

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• Schoultz, K., A. Svensson, and M. Emilsson, Nurses' experiences of using AsthmaTuner - an eHealth self-management system for healthcare of patients with asthma. Digit Health, 2022. 8: p. 20552076221092542.

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• 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.

  PMID: 31481605 BACKGROUND

• 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.

  BACKGROUND

• 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.

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• Wilkinson, T.M., et al., Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med, 2004. 169(12): p. 1298-303.

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• Schrijver, J., et al., Self-management interventions for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 2022. 1(1): p. CD002990.

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• Effing, T.W., et al., Definition of a COPD self-management intervention: International Expert Group consensus. Eur Respir J, 2016. 48(1): p. 46-54.

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• Riley, C.M. and F.C. Sciurba, Diagnosis and Outpatient Management of Chronic Obstructive Pulmonary Disease: A Review. JAMA, 2019. 321(8): p. 786-797.

  BACKGROUND

• Cravo, A., et al., The Importance of Self-Management in the Context of Personalized Care in COPD. Int J Chron Obstruct Pulmon Dis, 2022. 17: p. 231-243.

  BACKGROUND

• Organization, W.H., WHO package of essential non-communicable diseases interventions for primary health care. https://iris.who.int/bitstream/handle/10665/334186/9789240009226-eng.pdf?sequence=1.

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• Miller, J., et al., Comorbidity, systemic inflammation and outcomes in the ECLIPSE cohort. Respir Med, 2013. 107(9): p. 1376-84.

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• Parker, C.M., et al., Physiological changes during symptom recovery from moderate exacerbations of COPD. Eur Respir J, 2005. 26(3): p. 420-8.

  BACKGROUND

• Zafari, Z., et al., Projecting Long-term Health and Economic Burden of COPD in the United States. Chest, 2021. 159(4): p. 1400-1410.

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• Halpin, D.M.G., et al., It is time for the world to take COPD seriously: a statement from the GOLD board of directors. Eur Respir J, 2019. 54(1).

  BACKGROUND

• Mathers, C.D. and D. Loncar, Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med, 2006. 3(11): p. e442.

  BACKGROUND

• Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Eur Respir J. 2017 Mar 6;49(3):1700214. doi: 10.1183/13993003.00214-2017. Print 2017 Mar.

  PMID: 28182564 BACKGROUND

• Nordlund, B., et al., The clinical benefit of evaluating health-related quality-of-life in children with problematic severe asthma. Acta paediatrica, 2011. 100(11): p. 1454-60.

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• Jansson SA, Ronmark E, Forsberg B, Lofgren C, Lindberg A, Lundback B. The economic consequences of asthma among adults in Sweden. Respir Med. 2007 Nov;101(11):2263-70. doi: 10.1016/j.rmed.2007.06.029. Epub 2007 Aug 6.

  PMID: 17689234 BACKGROUND

• Mannino, D.M., A. Sonia Buist, and W.M. Vollmer, Chronic obstructive pulmonary disease in the older adult: what defines abnormal lung function? Thorax, 2007. 62(3): p. 237-41.

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• Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

  PMID: 17507545 BACKGROUND

• World Health Organization: Chronic obstructive pulmonary disease (COPD):. [cited 2024 Dec.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Henrik Ljungberg

CONTACT

+46706628642; henrik.ljungberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Associate Professor, Senior Lecturer and Research Group Leader at Karolinska Institutet (KI)

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: May 7, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)