Clinical Trials for Elderly Patients With Multiple Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure (CHF); Sleep Disordered Breathing (SDB)
• Interventions: Device: CHROMED monitoring system

• Registration Number: NCT01960907
• Lead Sponsor: Restech Srl

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2016-07-26
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Results First Posted: 2016-09-30
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	CHROMED monitoring system	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.

Primary Outcome Measures

Name	Time	Method
Final Utility Index of EQ-5D Questionnaire	9 months	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.
Time to First Hospitalization	From enrolment up to 9 months	It represents the number of days, since the enrolment into the study, to the first hospitalization

Trial Locations

Locations (6)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Lincolnshire Community Health Service; 🇬🇧 Lincoln, United Kingdom

Aintree University Hospital; 🇬🇧 Liverpool, United Kingdom

Hospital clinic; 🇪🇸 Barcelona, Spain

Bolnisnica Sežana Zavod; 🇸🇮 Sežana, Slovenia

Institute of Clinical Medicine; 🇪🇪 Tallin, Estonia