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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960907
First Posted: October 11, 2013
Last Update Posted: September 30, 2016
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.
Collaborators:
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
October 9, 2013
October 11, 2013
July 26, 2016
September 30, 2016
September 30, 2016
October 2013
April 2016   (Final data collection date for primary outcome measure)
  • 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.
  • Increase of time since first hospitalization [ Time Frame: 9 months ]
    An increase of 25% in the time since first hospitalization
  • Improvement in patient health status [ Time Frame: 9 months ]
    A 15% improvement in the health status of patients in the active management group quantified by the final score of the EQ-5D questionnaire
Complete list of historical versions of study NCT01960907 on ClinicalTrials.gov Archive Site
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Clinical Trials for Elderly Patients With Multiple Disease
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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure (CHF)
  • Sleep Disordered Breathing (SDB)
Device: CHROMED monitoring system
Optimization of patient's treatment according to the data collected by the home monitoring devices
  • 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.

    Intervention: Device: CHROMED monitoring system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   Slovenia,   Spain,   Sweden,   United Kingdom
 
 
NCT01960907
CHROMEDB
No
Not Provided
Not Provided
Pasquale Pio Pompilio, Restech Srl
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
Principal Investigator: Peter Calverley, Phd, MD University of Liverpool
Restech Srl
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP