Clinical Trials for Elderly Patients With Multiple Disease

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Apnea Cardiovascular Diseases Chronic Disease Congestive Heart Failure (CHF) Disease Attributes Dyssomnias Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disordered Breathing (SDB) Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Clinical Medicine, Tallinn, Estonia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHROMED monitoring system

Device

Optimization of patient's treatment according to the data collected by the home monitoring devices

Primary outcomes

Time to First Hospitalization

Time frame: From enrolment up to 9 months

It represents the number of days, since the enrolment into the study, to the first hospitalization
Final Utility Index of EQ-5D Questionnaire

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Restech Srl

Industry

Collaborators

Hospital of Sezana
Tesan spa
University Hospital of North Norway
University of Barcelona
University of Lincoln
University of Liverpool
University of Tallin
Uppsala University

Registry information

Acronym: CHROMED

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Oct 11, 2013
Registry last updated: Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed