Clinical Research Directory

Digital Tool for Improved Self-management of COPD

Sponsor: Björn Nordlund

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)

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