Madrid Project on the Management of Chronic Obstructive Pulmonary Disease With Home Telemonitoring
Condition: COPD; Disease Progression
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Disease Progression
Study type: Interventional

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.
    

Detailed description: 
      Randomized, controlled, multicenter, performance, cost assessment and economic evaluation
      clinical trial. An arm of the trial will consist of patients assigned to the intervention
      group (telehealth group: TG ), and the other arm will consist of patients randomized to the
      control group (routine clinical practice: RCP).

      For the economic evaluation, the perspective of the health system will be used. Therefore it
      only direct costs will be considered. In the TG arm also intervention costs it will be
      considered.

      Patient selection:

      Responsible researcher at each hospital center will coordinate the patient selection process.
      The researchers will identify candidate patients screening through hospital medical records.

      After this first screening, patients will be contacted and invited to participate in the
      study. In a personal interview, the researcher explains the study to the patient and deliver
      the information sheet, verifying that patient meets all inclusion/exclusion criteria, obtains
      informed consent and then proceeds to patient randomization. To avoid bias from exclusions,
      researchers will hold record with patient exclusion causes.

      Every hospital centers will include on average 60 patients (30 in each arm). The inclusion of
      patients will be competitive; having centers including patients in the study until reaching
      the final sample size of 120 patients per arm.

      Randomization:

      To avoid selection bias, patients assigned to each group will be randomized. To ensure that
      the number of subjects in each arm is the same, a restrictive block randomization is
      performed. Randomization is performed using random number generation by computer and the
      block size of 10 units.

      Home Telehealth program:

      Vital sign devices being used: spirometer, pulse oximeter with capacity for heart rate
      monitor, blood pressure, Visionox® (device capable of measuring respiratory rate, compliance
      with the hours of oxygen, and the flow and pattern of oxygen used).

      Devices send data automatically to a modem by Bluetooth. Modem receives and transmits data
      simultaneously from the monitoring devices to a Central Monitoring Center (CMC). Data
      received by the modem are encrypted and sent to the telehealth monitoring platform via a 3G
      signal.

      The CMC is manned by registered nurses and operates during office hours, 7 days a week.

      Nurses will attend the patient's home for: the installation of the telehealth devices; to
      perform a thorough training of the patients / caregivers in the use of equipment and the COPD
      telehealth program.

      Patients will perform daily vital sign measurements at the same time, at rest, after
      administration of the medication and the pattern of oxygen used. Visionox® performs
      measurements of respiratory rate and oxygen adherence automatically.

      Measured data will be monitored on a daily bases by the nurses at the CMC. CMC will follow-up
      information, filter for fle positives and false negatives, and use an application acting as a
      traffic light system:

        -  Green: meant that measurements had been taken and were within the predefined limits, and
           no further action was required.

        -  Yellow: "technical alert". This means that the measurements had not been taken or had
           not been received. This alert could lead to a "clinical alert" due to a lack of
           adherence or discouragement. When the parameters were not received the nurse at the CMC
           called the patient to find the reason behind the alert, and either ruled out medical
           causes or, if one, notified the researcher leading the study.

        -  Red: "clinical alert". Meant that a measurement exceeded the limits that were previously
           preestablished for each.

      Classification of severity of clinical alerts is performed by the CMC according to an
      algorithm. Depending n severity different early medical interventions are taken, or escalated
      to clinical responsible for early intervention.
    

Intervention name(s): Telehealth
Intervention type(s): Device
Intervention description(s): Monitoring devices installed at patients home and patients are monitored on a daily bases for early detection of exacerbations and prompt clinical intervention.and being follow-up on a daily bases for early detection and prompt intervention.
Other intervention name(s): Telemedicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention