COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A

Inclusion Criteria:

• Diagnosis of COPD (FEV1/FVC < 0.7) for at least a year.

• Participants with moderate-to-very severe COPD (FEV1 ≤ 80% predicted)

• Documented history of ≥ 1 moderate (treated with SABDs and oral corticosteroids ±antibiotics) or severe COPD exacerbation* within 12 months before enrolment.

• Adults aged 40 or over.

• Able to walk 4 meters independently with or without walking aids.

• Anticipated availability for repeated study visits over 12 months.

• Willingness to use smart sensors.

• Able to read and write in the first language in the respective location.

• Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and thestudy protocol.

Exclusion Criteria:

• Occurrence of any of the following within three months before informed consent:myocardial infarction, hospitalization for unstable angina, stroke, coronary arterybypass graft (CABG), percutaneous coronary intervention (PCI), implantation of acardiac resynchronization therapy device (CRTD).

• Uncontrolled congestive heart disease (NYHA class >3).

• Having undergone major lung surgery (e.g., lung transplant)

• Primary respiratory diseases other than COPD.

• Participant who has experienced a major respiratory infection or exacerbation within 2 weeks before screening

• Lung volume reduction within six months before screening.

• Active treatment for cancer or other malignant diseases that in the opinion of theinvestigator, have an impact on the patient's quality of life such as to preventadherence to the study.

• Acute psychosis or major psychiatric disorders or continued substance abuse.

• Severe disease that limits survival to 1 year.

• Patients with severe cognitive impairment (MMSE < 18).

• Substantial limitations in mobility due to factors other than COPD.

• Inability to follow the study procedures (e.g., due to language problems,psychological disorders) or unable to read, understand and fill in a questionnaire.