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Validation of prognostic indices ADO, BODEx and DOSE in a primary care international cohort (cohort PROEPOC/PROCOPD)

COPD patients prognosis with multicomponent scales (ADO, BODEx) in primary care: scale validation study, open, multicenter and prospective

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN52402811
Enrollment
477
Registered
2015-02-05
Start date
2015-02-10
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory

Interventions

Those patients who are diagnosed with COPD and cared for by participating general practitioners will be included, provided that they fulfil the inclusion criteria. The healthcare professionals will id
if the last test was more than 6 months ago, a new spirometry test will have to be taken. A forced spirometry test is required, for which the recommendations of the Spanish Society for Pneumology and

Sponsors

Instituto de Salud Carlos III (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 20/01/2016: Setting: Primary Care Centres in Teis, Matamá, Pazos de Borbén and Sárdoma in the Vigo Health Authority (Pontevedra, Galicia), and Son Pisà, Escola Graduada and Coll dén Rebassa in the Balearic Islands Health Authority (Balearic Islands). Through these centres, doctors/nurses potentially willing to participate were identified (using the ‘snowball’ method) both in Spain (Aragón, Catalonia, Canary Islands) and other European countries (Bulgaria, Croatia, Germany, Macedonia, Romania and Slovenia, in Europe). Subjects: Patients diagnosed with COPD. Inclusion criteria: 1. Patients with an obstruction, defined by a FEV1 lower than 80% of the expected post-bronchodilator FEV in the presence of a FEV1 quotient/forced vital capacity (FVC) lower than 70%. 2. Patients in a stable phase of COPD, clinically defined as at least 6 weeks since the last exacerbation 3. Acceptance to participate in the study by providing written informed consent Previous inclusion criteria: Setting: Primary Care Centres in Teis, Matamá, Pazos de Borbén and Sárdoma in the Vigo Health Authority (Pontevedra, Galicia), and Son Pisà, Escola Graduada and Coll dén Rebassa in the Balearic Islands Health Authority (Balearic Islands). Through these centres, doctors/nurses potentially willing to participate will be identified (using the ‘snowball’ method) both in Spain and other European countries to be confirmed. Subsequently, they will be invited and informed by e-mail about the description of the background and objectives of the study, as well as the implications of their participation. Subjects: Patients diagnosed with COPD. Inclusion criteria: 1. Patients with an obstruction, defined by a FEV1 lower than 80% of the expected post-bronchodilator FEV in the presence of a FEV1 quotient/forced vital capacity (FVC) lower than 70%. 2. Patients in a stable phase of COPD, clinically defined as at least 6 weeks since the last exacerbation 3. Acceptance to participate in the study by providing written informed consent

Exclusion criteria

Exclusion criteria: COPD patients. Exclusion criteria: 1. Patients diagnosed with cystic fibrosis, or bronchiectasis of a different origin to COPD (tuberculosis, childhood infections, immunodeficiencies, and severe cognitive or mobility impairment). 2. Patients diagnosed with a severe chronic disease, besides COPD (active malignancy, AIDS, heart failure, severe kidney or liver failure, etc.)

Design outcomes

Primary

MeasureTime frame
Survival without exacerbations will be assessed after 3, 4 and 5 years.

Secondary

MeasureTime frame
Mortality from all causes and those specifically due to respiratory causes (secondary)

Countries

Bulgaria, Croatia, Germany, Macedonia, Romania, Slovenia, Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026