CHROMED: Clinical study on elderly patients with multiple diseases (Chromed)

Published on: 29/01/2013

CHROMED is an European project aimed at evaluating the impact of adopting a health and  lifestyle status management system to support elderly patients with a combination of chronic diseases involving respiratory and cardiovascular systems. A large scale clinical trial will be implemented to develop and evaluate clinical protocols and organizational models based on the new technologies in order to improve both quality of life and healthcare costs associated with these patients.

The CHROMED idea arises from a previously successful research experience in patient monitoring at home. 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. For over 9 months, an international multi-centric randomized control trial will be implemented on 300 patients in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe. In each country, the participating care organisations have existing practices and procedures for age-related disease management. In CHROMED a specific ICT platform in combination with a set of both well established and innovative devices will be used to collect and process useful clinical data at the patient’s home. In particular, for each patient a set of devices will be defined considering the existing co-morbidities.

Description of target users and groups

CHROMED solution will be explored in contexts that represent different cultural and social environments in Europe and ensure a wide deployment.

The study is addressed to benefit several target groups:

  • elderly: they can take advantages from CHROMED in terms of personalized care assistance, improvement of communication with doctors, continuous health status monitoring and check of behaviour, improvement of quality of life, support in taking decisions related to lifestyle, improvement of patient adherence to therapies.
  • clinicians: that can substantially prolong the time that elderly people can live at home by providing ICT-based safety,  improve communication with patients, reduce unnecessary visits to hospitals, promote exacerbations prevention by patient training to a more healthy lifestyle, deliver evidence of improvements for quality of life of older people and their families.
  • enterprises, in terms of: large scale validation, know-how development, improvement of the devices according to the users experience and international standards, promotion of their products in the market at European level in glance of the project results evidence, creation of new business opportunities, approval of new patents.
  • academics, through: formalisation of new guidelines in the telemedicine applications for clinicians and health managers concerning the impact of COPD and CHF in ageing at the European level, generation of new data for newer studies, international cooperation in the research fields of the project.
  • public health authorities, which can find new methodologies in the treatment of exacerbations outside of the hospital with a consequent reduction of costs for hospital readmission and visits and improve in efficacy of treatment regimens.

Description of the way to implement the initiative

The CHROMED management and organizational activities aim to reach the technological and scientific objectives according to the project plan and within the allocated schedule, budgets, resources and with the needed quality. The project management is based on a clear definition of responsibilities for activities related to the given tasks.

CHROMED will carefully address the protection of human dignity and the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human in compliance with the national and international directives.

Technology solution

In CHROMED, an ICT platform will be used in combination with a set of both well established and highly innovative devices to collect and process useful clinical data at the patient’s home.

Considering the existing co-morbidities each patient will be equipped at home with a set of devices:

  •  RESMONPRO, a stand-alone device for measuring the mechanical properties of the respiratory system implementing the forced oscillation technique (FOT)
  •  For those COPD patients requiring monitoring of SpO2 or blood pressure and all patients with a coexistent diagnosis of CHF, an all-in-one wireless remote medical monitoring device, WRIST CLINIC, will be provided. It is able to record a wide variety of medical parameters: Heart rate, 1 lead ECG, Blood pressure, Heart rhythm regularity, Respiratory rate, Oxygen saturation, Body temperature
  • Actiwatch accelerometer to monitor patients activity
  • Innovative telemonitoring and telecontrolling system for CPAP and non invasive mechanical ventilation will be used in patients with a prescription of home CPAP to improve the therapy.

Furthermore, patients will be required to interact with the system through a touch-screen PC for:

  • drug reminder: to alert the patients when he/she has to take the prescribed pills or drugs
  • symptoms questionnaire: a validated list of questions repeating ambulatory clinician interview used to collect qualitative information by the patient status.

All information are automatically transmitted to the central database, that using a web-interface and ruled based algorithms allows health personnel to monitor patients status and give advices for worsening trend or risk situation.

As consequence, the information of the health personnel is more direct, accurate and complete improving the prognosis and the selection of the most appropriate treatment planning.

Technology choice: Standards-based technology

Main results, benefits and impacts

The added values of CHROMED solution are:

  • clinical-medical: early and in-time detection of disease worsening conditions;
  • economical: in-time predicted worsening of chronic disorders can diminishes the need of hospitalization and out-patient visits economising burden of total medical costs;
  • social: the best prevention of worsening the chronic disorders and prevention of well-being within elderly habitants is accurate monitoring of these patients’ health condition; prevention of chronic disease has enormous impact to society costs and wellbeing especially in elderly habitants.

By the implementation of this innovation, the most important expected results are:

  • An increased knowledge of COPD and its interaction with several comorbidities including CHF, being the first trial involving day-by-day monitoring of lung function and patients’ reported outcomes;
  • An increased objective knowledge on the development of exacerbations in COPD;
  • A validated clinical protocol and organizational model for telemedicine in COPD with common comorbidities (CHF, sleep disorders) with an accurate evaluation of impact in terms of both clinical and economic variables. This will be the first study ever able to provide definitive data on such a large cohort of patients.
  • A new system and ICT platform customized by appropriate changes and the development of clinical guideline that will be immediately available, if the trial will be successful, to improve quality of life and substantially reduce healthcare costs associated to this important burden which, if not adequately addressed, might seriously impact healthcare system sustainability in Europe.

This will lead to:

  • clinical impact: support the treatment of elderly patients affected by multiple chronic diseases, by improving their quality of life and reducing the number of exacerbations
  • economic impact: decrease the burden to follow and treat these patients, by decreasing the costs for healthcare utilization, and reducing the need for travelling for patients and caregivers.

Lessons learnt

The trials are ongoing at the time of this publication; as soon as the results of trials are available this section will be updated.

Scope: International