An observational study in Role of Frailty in COPD, sponsored by Azienda Ospedaliero-Universitaria di Modena. Recruiting at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Azienda Ospedaliero-Universitaria di Modena · Observational
Observational study on the influence of frailty on cardiovascular risk in COPD.
The study will investigate the influence that frailty can have on cardiovascular risk in patients with COPD. The project will assess the association between frailty and all-cause mortality, and the relationship between frailty and cardiovascular mortality, by comparing COPD patients living with frailty vs non-frail COPD patients.
The study participants will be outpatients with diagnosis of COPD according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines (www.goldcopd.org).
Frailty will be measured using the Clinical Frailty Scale (grades 1-9). Patients who are terminally ill (CFS = 9) will be excluded. Cognitive function will be explored using the Montreal Cognitive Assessment (MoCA) test.
The follow up will be at 12 and 24 months.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 300 is above the median of 225 across 493 observational studies indexed under Frailty.
Browse Frailty studies →Azienda Ospedaliero-Universitaria di Modena is the lead sponsor of 48 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.
Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months
At 12 and 24 months of follow up, cardiovascular events (including hospital admissions), deaths due to cardiovascular disease, deaths due to all-cause, deaths due to COPD will be recorded in COPD outpatients group.
Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
Number of cardiovascular events (including hospital admissions for cardiovascular events) at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
Time frame: 12 and 24 months
All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.
All-cause long-term mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
Time frame: 12 and 24 months
Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.
Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
Time frame: 12 and 24 months
Prevalence of frailty in COPD.
Prevalence of frailty in COPD.
Time frame: Baseline, at 12 and 24 months
Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.
Number of deaths due to COPD at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
Time frame: 12 and 24 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Started Feb 2024 (actual). Primary completion is estimated for Nov 2025, 20 months after the start.
Of 289 non-industry observational studies under Frailty, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 20 months is below that.
Counting every sponsor, half of 292 studies reached it within 29 months; a quarter within 12 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Azienda Ospedaliero-Universitaria di Modena