Predicting COPD Exacerbations with Unobtrusive Sensors
COPD Exacerbation Modelling Study Using Daily-life Data From Unobtrusive Sensors - the TOLIFE Clinical Study A
This study is testing whether using sensors to track daily activities can help doctors predict and manage flare-ups in people with COPD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Barcelona Institute for Global Health Academic / other |
| Locations | 3 sites (Großhansdorf, Schleswig-Holstein and 2 other locations) |
| Trial ID | NCT06172712 on ClinicalTrials.gov |
What this trial studies
This multicentric prospective cohort study aims to enhance the management of chronic obstructive pulmonary disease (COPD) by utilizing unobtrusive sensors to collect daily-life data from 150 patients at risk of exacerbations. Conducted across three tertiary hospitals in Spain, Germany, and Italy, the study will last 18 months, including a 12-month follow-up for each participant. The primary goal is to develop AI-based models that can predict moderate-to-severe COPD exacerbations early, thereby enabling clinicians to provide more personalized treatment. Additionally, the study seeks to estimate the dynamics of health-related quality of life over a year.
Who should consider this trial
Good fit: Ideal candidates include adults aged 40 and over with a diagnosis of moderate-to-very severe COPD and a history of exacerbations.
Not a fit: Patients with recent cardiovascular events or those unable to use smart sensors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of COPD exacerbations, allowing for timely interventions and better patient outcomes.
How similar studies have performed: Other studies utilizing AI for predicting COPD exacerbations have shown promise, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Großhansdorf, Schleswig-Holstein and 2 other locations
- Pulmonary Research Institute — Großhansdorf, Schleswig-Holstein, Germany (Recruiting)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Not_yet_recruiting)
- Hospital del Mar Research Institute — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Judith Garcia-Aymerich — Barcelona Institute for Global Health
- Study coordinator: Judith Garcia-Aymerich, MD; PhD
- Email: judith.garcia@isglobal.org
- Phone: +342147380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.