Chronic Obstructive Pulmonary Disease (COPD)CSANCT06172712
COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Barcelona Institute for Global Health at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Variations in daily life activity signals detected by unobtrusive sensors
- How many people
- 150 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 8 May 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site, 1 recruiting
- Recruiting
Pulmonary Research Institute
Großhansdorf, Schleswig-Holstein, 22927
Henrik Watz, +4941028881111, H.Watz@pulmoresearch.de
Italy1 site, 1 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Alessandro Celi, +39050995236, alessandro.celi@unipi.it
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar Research Institute
Barcelona, 08003
Joaquim Gea, +34618175694, jgea@psmar.cat
About this study
Official title: COPD Exacerbation Modelling Study Using Daily-life Data From Unobtrusive Sensors - the TOLIFE Clinical Study A
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.
- Being tested
- Variations in daily life activity signals detected by unobtrusive sensors
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Exacerbation, Remote patient monitoring, Predictive modeling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variations in daily life activity signals detected by unobtrusive sensorsOther
Patients will be equipped with unobtrusive devices for a duration of 12 months. Throughout this period, they will attend scheduled visits every three months following the baseline visit. These assessments will focus on determining the frequency of exacerbations, evaluating exercise capacity, measuring the severity of dyspnea, and assessing health-related quality of life. The data gathered from the sensors embedded in these unobtrusive devices will be instrumental in developing AI-based models. These models aim to accurately predict COPD exacerbations and effectively estimate the progression of the previously mentioned health outcome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of moderate-to-severe COPD exacerbations
Occurrence of moderate-to-severe COPD exacerbations at months 3, 6, 9, and 12, through medical records
Measured: Months 3, 6, 9, and 12
Secondary outcomes (3)
Changes in the health-related quality of life
Health-related quality of life at baseline, months 3, 6, 9, and 12, using the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The CCQ score ranges from 0 to 6, and the CAT score ranges from 0 to 40. Both questionnaires use higher scores to indicate a more severe impact of COPD on a patient's life.
Measured: Baseline, Month 3, 6, 9 and 12
Changes in the functional exercise capacity
Changes in the functional exercise capacity at baseline, month 3, 6, 9 and 12, as measured by the Six-minute walking distance
Measured: Baseline, Month 3, 6, 9 and 12
Changes in the dyspnoea severity grade
Changes in the dyspnoea severity grade at baseline, month 3, 6, 9, and 12, as measured by the modified Medical Research Council (MRC) Dyspnoea scale. The mMRC Dyspnoea scale ranges from 0 to 4, with higher scores indicating more severe dyspnea.
Measured: Baseline, Month 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start8 May 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, LungenClinic Grosshansdorf, Hospital del Mar Research Institute (IMIM), Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Universidad Politecnica de Madrid, TIMELEX, Avvale
- Responsible party
- Principal investigator, Judith Garcia-Aymerich, Barcelona Institute for Global Health
- Investigators
- Judith Garcia-Aymerich, Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172712
- Sponsor's protocol ID
- 101057103CSA
- Acronym
- CSA
- Status last verified
- May 2024
- First submitted
- 7 Dec 2023
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vasquez-Andrade R, Alcaraz-Serrano V, Buekers J, Bufano P, Laurino M, Celi A, Watz H, Gea J, Carbonaro N, Tognetti A, Garcia-Aymerich J. Development of an artificial intelligence prediction model for moderate-to-severe COPD exacerbations using continuous multiple unobtrusive sensors: protocol of a multicentre prospective observational study. BMJ Open Respir Res. 2026 Jun 4;13(1):e003942. doi: 10.1136/bmjresp-2025-003942.
PubMed 42242832
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD Exacerbation Modelling Study Using Daily-life Data From Unobtrusive Sensors - the TOLIFE Clinical Study A
- ClinicalTrials.gov ID
- NCT06172712
- Acronym / sponsor ID
- CSA / 101057103CSA
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Exacerbation, Remote patient monitoring, Predictive modeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- University of Pisa, LungenClinic Grosshansdorf, Hospital del Mar Research Institute (IMIM), Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Universidad Politecnica de Madrid, TIMELEX, Avvale
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variations in daily life activity signals detected by unobtrusive sensorsPatients will be equipped with unobtrusive devices for a duration of 12 months. Throughout this period, they will attend scheduled visits every three months following the baseline visit. These assessments will focus on determining the frequency of exacerbations, evaluating exercise capacity, measuring the severity of dyspnea, and assessing health-related quality of life. The data gathered from the sensors embedded in these unobtrusive devices will be instrumental in developing AI-based models. These models aim to accurately predict COPD exacerbations and effectively estimate the progression of the previously mentioned health outcome. | Other | – |
Primary outcome
Occurrence of moderate-to-severe COPD exacerbations
Time frame: Months 3, 6, 9, and 12
Occurrence of moderate-to-severe COPD exacerbations at months 3, 6, 9, and 12, through medical records
3 secondary outcomes
Changes in the health-related quality of life
Time frame: Baseline, Month 3, 6, 9 and 12
Changes in the functional exercise capacity
Time frame: Baseline, Month 3, 6, 9 and 12
Changes in the dyspnoea severity grade
Time frame: Baseline, Month 3, 6, 9 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 42242832Vasquez-Andrade R, Alcaraz-Serrano V, Buekers J, Bufano P, Laurino M, Celi A, Watz H, Gea J, Carbonaro N, Tognetti A, Garcia-Aymerich J. Development of an artificial intelligence prediction model for moderate-to-severe COPD exacerbations using continuous multiple unobtrusive sensors: protocol of a multicentre prospective observational study. BMJ Open Respir Res. 2026 Jun 4;13(1):e003942. doi: 10.1136/bmjresp-2025-003942.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Garcia-Aymerich principal investigator
Barcelona Institute for Global Health
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Barcelona Institute for Global Health at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith Garcia-Aymerich, MD; PhD (+342147380, judith.garcia@isglobal.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of moderate-to-severe COPD exacerbations (time frame: Months 3, 6, 9, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.