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Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

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ClinicalTrials.gov Identifier: NCT01960907
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
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

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE October 11, 2013
Results First Submitted Date  ICMJE July 26, 2016
Results First Posted Date  ICMJE September 30, 2016
Last Update Posted Date September 30, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
  • 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
Change History Complete list of historical versions of study NCT01960907 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trials for Elderly Patients With Multiple Disease
Official Title  ICMJE Clinical Trials for Elderly Patients With Multiple Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure (CHF)
  • Sleep Disordered Breathing (SDB)
Intervention  ICMJE Device: CHROMED monitoring system
Optimization of patient's treatment according to the data collected by the home monitoring devices
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2016)
312
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2013)
300
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   Slovenia,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960907
Other Study ID Numbers  ICMJE CHROMEDB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pasquale Pio Pompilio, Restech Srl
Study Sponsor  ICMJE Restech Srl
Collaborators  ICMJE
  • University of Liverpool
  • Uppsala University
  • University of Lincoln
  • University of Tallin
  • University of Barcelona
  • Hospital of Sezana
  • University Hospital of North Norway
  • Tesan spa
Investigators  ICMJE
Principal Investigator: Peter Calverley, Phd, MD University of Liverpool
PRS Account Restech Srl
Verification Date September 2016

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