Clinical Trials for Elderly Patients With Multiple Disease

NCT01960907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2016-09-30

Study results available
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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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure (CHF)
  • Sleep Disordered Breathing (SDB)

Interventions

DEVICE

CHROMED monitoring system

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

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • University of Lincoln

    collaborator OTHER
  • University of Tallin

    collaborator UNKNOWN
  • University of Barcelona

    collaborator OTHER
  • Hospital of Sezana

    collaborator UNKNOWN
  • University Hospital of North Norway

    collaborator OTHER
  • Tesan spa

    collaborator UNKNOWN
  • Restech Srl

    lead INDUSTRY

Principal Investigators

  • Peter Calverley, Phd, MD · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Estonia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960907 on ClinicalTrials.gov