Clinical Trials for Elderly Patients With Multiple Disease (CHROMED)

September 29, 2016 updated by: Pasquale Pio Pompilio, Restech Srl
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallin, Estonia, 12618
        • Institute of Clinical Medicine
  • Slovenia
      • Sežana, Slovenia, 6210
        • Bolnisnica Sežana Zavod
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic
  • Sweden
      • Uppsala, Sweden, SE-751 85
        • Uppsala University Hospital
  • United Kingdom
      • Lincoln, United Kingdom, LN6 7TS
        • Lincolnshire Community Health Service
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrolment up to 9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restech Srl

Collaborators

Uppsala University
University Hospital of North Norway
University of Lincoln
University of Liverpool
University of Barcelona
University of Tallin
Hospital of Sezana
Tesan spa

Investigators

  • Principal Investigator: Peter Calverley, Phd, MD, University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHROMEDB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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