Actively Recruiting
COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A
Led by Barcelona Institute for Global Health · Updated on 2024-05-20
150
Participants Needed
3
Research Sites
64 weeks
Total Duration
On this page
Sponsors
B
Barcelona Institute for Global Health
Lead Sponsor
U
University of Pisa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 are at risk of exacerbations. These patients are recruited from three tertiary hospitals in Spain, Germany, and Italy. The study will last 18 months, with a 12-month follow-up duration for each patient. The primary objective of this study is to develop and test Artificial Intelligence (AI)-based models that can predict moderate-to-severe COPD exacerbations early on. This will be done by analyzing daily-life data collected from unobtrusive sensors that monitor patients' psycho-physiological and environmental signals. By accurately predicting exacerbations, the study aims to support clinicians in providing more precise, optimized, and personalized treatment to COPD patients. A secondary objective is to train and test AI-based models to estimate the 12-month dynamics of health-related quality of life (HRQoL) in COPD patients. This will involve analyzing data related to the patients' functional exercise capacity, dyspnea (difficulty breathing), and health-related quality of life, as measured by the Clinical COPD Questionnaire (CCQ) score and the COPD Assessment Test (CAT) score.
CONDITIONS
Official Title
COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of COPD (FEV1/FVC < 0.7) for at least one year
- Moderate-to-very severe COPD (FEV1 64 80% predicted)
- History of 65 one moderate or severe COPD exacerbation within 12 months before enrollment
- Adults aged 40 years or older
- Able to walk 4 meters independently with or without walking aids
- Expected availability for repeated study visits over 12 months
- Willingness to use smart sensors
- Able to read and write in the first language of the study location
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Myocardial infarction, unstable angina hospitalization, stroke, coronary artery bypass graft, percutaneous coronary intervention, or cardiac resynchronization therapy device implantation within 3 months before consent
- Uncontrolled congestive heart disease (NYHA class >3)
- Previous major lung surgery such as lung transplant
- Primary respiratory diseases other than COPD
- Major respiratory infection or exacerbation within 2 weeks before screening
- Lung volume reduction within 6 months before screening
- Active cancer treatment or other malignant diseases impacting quality of life and adherence
- Acute psychosis, major psychiatric disorders, or ongoing substance abuse
- Severe disease limiting survival to 1 year
- Severe cognitive impairment (MMSE < 18)
- Significant mobility limitations unrelated to COPD
- Inability to follow study procedures or complete questionnaires due to language or psychological issues
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Pulmonary Research Institute
Großhansdorf, Schleswig-Holstein, Germany, 22927
Actively Recruiting
2
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Not Yet Recruiting
3
Hospital del Mar Research Institute
Barcelona, Spain, 08003
Actively Recruiting
Research Team
J
Judith Garcia-Aymerich, MD; PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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