Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

RESTECH

Status: Completed

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

Treatments: Device: CHROMED monitoring system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01960907

CHROMEDB

Details and patient eligibility

About

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.

Enrollment: 312 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

Observational

No Intervention group

Description:

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

Interventional

Experimental group

Description:

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.

Treatment:

Device: CHROMED monitoring system