Status:
RECRUITING
COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A
Lead Sponsor:
Barcelona Institute for Global Health
Collaborating Sponsors:
University of Pisa
LungenClinic Grosshansdorf
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Brief Summary
This work is a multicentric prospective cohort study designed to improve chronic obstructive pulmonary disease (COPD) treatment and management. The study involves 150 patients diagnosed with COPD who ...
Eligibility Criteria
Inclusion
- 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 the requirements and restrictions listed in the informed consent form (ICF) and the study protocol.
Exclusion
- Occurrence of any of the following within three months before informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac 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 the investigator, have an impact on the patient's quality of life such as to prevent adherence 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.
Key Trial Info
Start Date :
May 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06172712
Start Date
May 8 2024
End Date
July 31 2025
Last Update
May 20 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Pulmonary Research Institute
Großhansdorf, Schleswig-Holstein, Germany, 22927
2
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
3
Hospital del Mar Research Institute
Barcelona, Spain, 08003