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
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Congestive Heart Failure
Sleep Disordered Breathing
Device: CHROMED monitoring system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Trials for Elderly Patients With Multiple Disease

Resource links provided by NLM:


Further study details as provided by Restech Srl:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960907

Locations
Estonia
Institute of Clinical Medicine Recruiting
Tallin, Estonia, 12618
Contact: Ruth Sepper, PhD       ruth.sepper@gmail.com   
Contact: Kaiu Prikk, PhD       kaiu.prikk@gmail.com   
Principal Investigator: Ruth Sepper, Phd         
Principal Investigator: Kaiu Prikk, PhD         
Slovenia
Bolnisnica Sežana Zavod Recruiting
Sežana, Slovenia, 6210
Contact: Silvana Šonc       silvana.sonc@bsezana.si   
Principal Investigator: Silvana Šonc         
Principal Investigator: Dorijan Marušič, MD         
Spain
Hospital clinic Recruiting
Barcelona, Spain, 08036
Contact: Valentina Isetta, PhD       valentina.isetta@ub.edu   
Principal Investigator: Valentina Isetta, PhD         
Principal Investigator: Ramon Farre', PhD         
Principal Investigator: Josep Montserrat, MD         
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-751 85
Contact: Andrei Malinovschi, PhD       andrei.malinovschi@medsci.uu.se   
Contact: Katarina Nisser       Katarina.Nisser@medsci.uu.se   
Principal Investigator: Andrei Malinovschi, PhD         
Principal Investigator: Chister Janson, MD         
United Kingdom
Lincolnshire Community Health Service Recruiting
Lincoln, United Kingdom, LN6 7TS
Contact: Niroshan Siriwardena, MD       nsiriwardena@lincoln.ac.uk   
Contact: Jo Middlemass       jmiddlemass@lincoln.ac.uk   
Principal Investigator: Niroshan Siriwardena, MD         
Aintree University Hospital Recruiting
Liverpool, United Kingdom, L9 7AL
Contact: Peter Calverley, PhD, MD       pmacal@liverpool.ac.uk   
Contact: Paul Walker, MD       PAUL.WALKER@aintree.nhs.uk   
Principal Investigator: Paul Walker, MD         
Principal Investigator: Peter Calverley, MD, PhD         
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
Investigators
Principal Investigator: Peter Calverley, Phd, MD University of Liverpool
  More Information

Additional Information:
Publications:

Responsible Party: Pasquale Pio Pompilio, PhD, Restech Srl
ClinicalTrials.gov Identifier: NCT01960907     History of Changes
Other Study ID Numbers: CHROMEDB
Study First Received: October 9, 2013
Last Updated: October 12, 2013
Health Authority: Estonia: Research Ethics Committee
Slovenia: Ethics Committee
Sweden: Regional Ethical Review Board
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Restech Srl:
COPD
CHF
SDB

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Sleep Apnea Syndromes
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014