Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT02499068
Eligibility Criteria:
Inclusion Criteria:
* Being over 50 and under 90 years of age.
* Being diagnosed with COPD according to the criteria of GesEPOC, with severe airflow obstruction defined as a forced expiratory volume in one second (FEV1) less than 50% of theoretical.
* "Exacerbator phenotype" defined as COPD patients having two or more moderate or severe exacerbations per year (GesEPOC guide). These exacerbations should be separated by at least 4 weeks after the end of previous treatment or 6 weeks from the start in cases that have not been treated
* Clinically stable condition, defined as 6 weeks without clinical symptoms since the last exacerbation of COPD.
* Having home oxygen therapy.
* Sign the informed consent.
Exclusion Criteria:
* Inability of the patient or caregiver to understand the procedure of Telehealth program.
* Have a life expectancy of less than one year.
* Have terminal heart failure (NYHA functional class III-IV).
* Having advanced renal insufficiency (creatinine clearance \<30%) or be on dialysis program.
* Have liver cirrhosis or be included in a program of liver transplantation.
* Be institutionalized or in Residential hospice care.
* Having a mini-mental test-score less than 24, because this score suggests dementia
* To be considered by your doctor as not comply the treatment or monitoring required by their lung disease.
* Failure to meet any of the inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT02499068
Study Brief:
Protocol Section:
NCT02499068