Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)
Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, CHF, SDB
Eligibility Criteria
Inclusion Criteria:
- COPD GOLD grade II or higher with a prior history of exacerbations and/or an hospitalization for COPD in the previous year with one or more documented non-pulmonary chronic conditions such as:
- CHF due to left ventricular systolic dysfunction (LVSD) confirmed on echocardiography
- SDB identified by respiratory sleeping studies or polysomnography
- current or prior smoking history of >= 10 pack/years
- subjects capable of providing signed written informed consent
- subjects capable of perform study procedures and use the RESMONPRO at home
- subjects with reliable mobile phone coverage at home
Exclusion Criteria:
- Any disease that, in the opinion of the investigator, put the subject at risk
- subjects with significant vision disturbance and mental diseases
- subjects with a planned prolonged absence from home
Sites / Locations
- Institute of Clinical Medicine
- Bolnisnica Sežana Zavod
- Hospital clinic
- Uppsala University Hospital
- Lincolnshire Community Health Service
- Aintree University Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Observational
Interventional
Subjects in the observational arm will receive monthly interviews for collecting informations about their status and level of utilization of healthcare resources. They will follow their usual care path as provided by their local NHS
Patients will receive a system form monitoring their health status. The system is composed by: a touch-screen pc for the administration of daily questionnaires RESMONPRO DIARY for the measurement of lung mechanical impedance and breathing pattern a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature. Subjects will receive medical treatment following the activation of alarms by the monitoring devices. Monthly phone interviews will be performed to collect data about their level of utilization of the health care system.