Clinical Trials for Elderly Patients With Multiple Disease

Study Overview
=================
Brief Summary
-----------------
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.

Official Title
-----------------
Clinical Trials for Elderly Patients With Multiple Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)

Intervention / Treatment
-----------------
* Device: CHROMED monitoring system


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observational<br>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 | |
| Experimental: Interventional<br>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. | Device: CHROMED monitoring system<br>* Optimization of patient's treatment according to the data collected by the home monitoring devices<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Hospitalization | It represents the number of days, since the enrolment into the study, to the first hospitalization | From enrolment up to 9 months | 
| Final Utility Index of EQ-5D Questionnaire | The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, CHF, SDB