Please select the outcome measures 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: Number of hospitalizations (2011)
B: The number of ED presentations (1 year after randomization.)
C: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
D: Death (30 days, 3 months, 6 months); readmission (30 days, 3 months, 6 months); need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator) (30 days, 3 months, 6 months); Self-efficacy (3 days); Cognitive function (3 days and six weeks after discharge)

Answer: D