Please select the eligibility criteria that correspond to the clinical trial below.
Title: Proyecto Madrileño Sobre el Manejo de la Enfermedad Pulmonar Obstructiva Crónica Con Telemonitorización a Domicilio. (Multicentre Project on the Home Telemonitoring of Patients With Severe Chronic Obstructive Pulmonary Disease).
Brief Summary: The purpose of the study is to verify the clinical effectiveness of a managed home telemonitoring program in patients with severe COPD against usual clinical practice, as measured by the decrease in the number of exacerbations, number of hospitalizations, hospital days and emergency room visits in a 12 month period

The primary endpoint of effectiveness is "severe exacerbations avoided."

The main hypothesis is that patients with severe or very severe COPD patients managed with a home telehealth program have better outcomes than patients managed according to usual clinical practice.


Options:
A: Inclusion Criteria:

* COPD defined as chronic irreversible airflow limitation with FEV1 \< lower limit of normal for age as % predicted and a FEV1/FVC ratio \< than lower limit of normal (usually 70%) \[5\]

Plus ≥ 2 comorbidities commonly associated with COPD as identified in the Canadian Thoracic Society COPD guidelines\*

1. Cardiovascular disease
2. Osteopenia and osteoporosis
3. Glaucoma and cataracts
4. Cachexia and malnutrition
5. Peripheral muscle dysfunction
6. Lung cancer
7. Metabolic syndrome (diabetes mellitus)
8. Depression
9. Chronic kidney disease OR Other conditions as primary admitting/presenting diagnosis + COPD as significant comorbidity + ≥ 1 other comorbidity

THAT

1. Get admitted to participating hospital; or
2. Present to participating hospital ED; or
3. Have first referral to Respiratory Centre/Respirology team

AND HAVE

1. ≥ 1 ED presentation/hospital admission in previous 12 months
2. ≥ 50 years age

Exclusion Criteria:

1. No access to primary care physician
2. Primary diagnosis of asthma
3. Terminal diagnosis (metastatic disease with a life expectancy of ≤ 6 months)
4. Dementia and absence of family caregiver able to assist with activation of the action plan and feedback on ongoing status and care coordination
5. Uncontrolled psychiatric illness
6. Inability to understand, read, and write English
7. No access to a phone
8. Inability to attend follow up at one of the participating sites
B: Inclusion Criteria:

* Confirmed Gold III/IV COPD
* Current or ex-smoker with a smoking history ≥ 10 pack-years
* At least one COPD exacerbation leading to hospitalization in the year before selection.

Exclusion Criteria:

* LTOT for another reason than COPD
* Severe concomitant disorder associated with a limited probability of survival (\< 6 months)
* Tracheostomy
* Long term oral corticosteroids therapy
C: Inclusion Criteria:

* CRF patients discharged from Respiratory Unit with home MV

Exclusion Criteria:

* Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
* Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
* Being admitted to a nursing home
* Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
* Refusal to give informed consent
D: 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.

Answer: D