Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Restech Srl
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01960907
First received: October 9, 2013
Last updated: October 12, 2013
Last verified: October 2013

October 9, 2013
October 12, 2013
October 2013
March 2016   (final data collection date for primary outcome measure)
  • Increase of time since first hospitalization [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    An increase of 25% in the time since first hospitalization
  • Improvement in patient health status [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    A 15% improvement in the health status of patients in the active management group quantified by the final score of the EQ-5D questionnaire
Same as current
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: Open Label
Primary Purpose: Supportive Care
  • Chronic Obstructive Pulmonary Disease
  • Congestive Heart Failure
  • Sleep Disordered Breathing
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.
 
Recruiting
300
March 2016
March 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
Both
65 Years and older
No
United Kingdom,   Slovenia,   Spain,   Estonia,   Sweden
 
NCT01960907
CHROMEDB
No
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
October 2013

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