Clinical trial NCT06172712: COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A
Official title: COPD Exacerbation Modelling Study Using Daily-life Data From Unobtrusive Sensors - the TOLIFE Clinical Study A
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Exacerbation
Remote patient monitoring
Predictive modeling
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
Collaborators: name: University of Pisa
name: LungenClinic Grosshansdorf
name: Hospital del Mar Research Institute
name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Universidad Politecnica de Madrid
name: TIMELEX
name: Avvale
First posted: 2023-12-15
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study targets COPD patients at risk of moderate-to-severe exacerbations. Participants will be recruited from three European tertiary care hospitals: Hospital del Mar in Barcelona, Spain; the Pulmonary Research Institute in Grosshansdorf, Germany; and Azienda Ospedaliera Universitaria Pisana in Pisa, Italy. Recruitment sources include research registers, hospital records, and referrals.

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 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.


Eligibility criteria: 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 the requirements and restrictions listed in the informed consent form (ICF) and the study protocol.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Occurrence of moderate-to-severe COPD exacerbations
timeFrame: Months 3, 6, 9, and 12
Secondary outcomes:
measure: Changes in the health-related quality of life
timeFrame: Baseline, Month 3, 6, 9 and 12
measure: Changes in the functional exercise capacity
timeFrame: Baseline, Month 3, 6, 9 and 12
measure: Changes in the dyspnoea severity grade
timeFrame: Baseline, Month 3, 6, 9 and 12
Other outcomes:
Locations:
city: Großhansdorf
country: Germany
facility: Pulmonary Research Institute
state: Schleswig-Holstein
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Barcelona
country: Spain
facility: Hospital del Mar Research Institute
Study officials:
affiliation: Barcelona Institute for Global Health
name: Judith Garcia-Aymerich
role: PRINCIPAL_INVESTIGATOR
References: