Please select the eligibility criteria that correspond to the clinical trial below.
Title: Consecutive, Randomized Controlled Multicenter Trial, Investigating the Feasibility and Safety of a Telemedicine Based Treatment Regimen in Patients With Chronic Obstructive Pulmonary Disease (COPD), Compared to Conventional Hospital Treatment
Brief Summary: Introduction:

With the rapid development in technology telemedicine has become a tool with the potential to improve and optimize the treatment of different diseases and to make diagnostics, treatment and counseling possible over shorter or longer distances.

Home based telemedicine is a new method that leads to a series of important questions that needs to be answered. This study is designed to answer questions concerning patient safety in telehomecare, the patients´ quality of life, efficiency and a cost benefit analysis of implementing this technology.

This study is about patients with chronic obstructive pulmonary disease (COPD) who are admitted to the hospital with an acute exacerbation. Approximately 24 hours after admission half of the patients are randomized to be admitted to their own home supported by telemedical equipment while the other half remain admitted at the hospital (typically between 5-7 days).

Primary Aim:

To investigate if telemedical surveillance and treatment in the recovery period of an acute exacerbation is just as safe as conventional admission of patients with COPD measured on treatment failure.

Secondary Aims:

To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD:

1. Is comparable in reestablishing Forced Expiratory Volume in 1 second (FEV1).
2. Demands the same number of treatment days/time before discharge/cessation of telemedical surveillance.
3. Is comparable in quality of life in the two groups of treated patients.
4. Have comparable adverse event profiles.
5. leads to a lower total cost in health services (health economical analysis)
6. Is possible to do for the patients (drop-outs because of the technical equipment or the patient does not know how to use the equipment.)

7 Is better seen from the physician's perspective when it comes to:

1. The virtual patient contact / communication
2. Technology
3. The work process compared to the conventional work process
4. Time spent with the patient
5. Usability
6. Improvement potentials ("the doctors view")

   8. The equipment is satisfactory for the patient to use

   Method

   For this study a telemedical platform has been developed on which it is possible to treat patients in their own homes. The platform consists of a videoconference part that allows the patients to make contact to qualified medical staff and a technology part that can transfer vital indicators of the patients´ health condition (lung function, oxygen saturation, pulse etc.) 175 patients will be included with an expected drop-out of 20 % or 35 patients. The patients will be equally recruited from two hospitals (Frederiksberg and Herlev Hospital). All patients must have an exacerbation in their COPD that requires hospitalization to be included in this study. Each patient participates in the study for 6 months after discharge with follow-up at 1, 3 and 6 months.


Options:
A: Inclusion Criteria:

* clinical diagnosis of COPD (III-IV)
* receive help from homecare nurse
* not suffering from any other serious disease, with expected lifespan less than 6 months

Exclusion Criteria:

-
B: 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
C: 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.
D: Inclusion Criteria:

* Clinical diagnosis of COPD stage III or IV according to GOLD guidelines
* \>45 years of age
* Compliant patient (is able to see, hear and follow instructions)
* Estimated admission time \> 2 days

Exclusion Criteria:

* X-score \> 4 at randomization(need of NIV or respirator)
* severe overweight assessed by investigator
* serious comorbidity (malignancy,unstable heart disease, dysregulated diabetes or other disease that makes participation impossible)
* non-compliant patient (cannot follow simple instructions)
* fever (\>38 degrees Celsius) at randomization point, in need of I.V. antibiotics assessed by investigator
* participation in another clinical trial within the last 30 days

Answer: D