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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960907
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
University of Liverpool
Uppsala University
University of Lincoln
University of Tallin
University of Barcelona
Hospital of Sezana
University Hospital of North Norway
Tesan spa
Information provided by (Responsible Party):
Pasquale Pio Pompilio, 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Congestive Heart Failure (CHF) Sleep Disordered Breathing (SDB) Device: CHROMED monitoring system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Trials for Elderly Patients With Multiple Disease
Study Start Date : October 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
No Intervention: Observational

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

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

Primary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960907

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Institute of Clinical Medicine
Tallin, Estonia, 12618
Bolnisnica Sežana Zavod
Sežana, Slovenia, 6210
Hospital clinic
Barcelona, Spain, 08036
Uppsala University Hospital
Uppsala, Sweden, SE-751 85
United Kingdom
Lincolnshire Community Health Service
Lincoln, United Kingdom, LN6 7TS
Aintree University Hospital
Liverpool, United Kingdom, L9 7AL
Sponsors and Collaborators
Restech Srl
University of Liverpool
Uppsala University
University of Lincoln
University of Tallin
University of Barcelona
Hospital of Sezana
University Hospital of North Norway
Tesan spa
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Principal Investigator: Peter Calverley, Phd, MD University of Liverpool

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pasquale Pio Pompilio, PhD, Restech Srl Identifier: NCT01960907    
Other Study ID Numbers: CHROMEDB
First Posted: October 11, 2013    Key Record Dates
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Pasquale Pio Pompilio, Restech Srl:
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases