Remote Monitoring of Patients With CHF in Central Greece (RHCluster7GR)

Renewing Health RCT for the Evaluation of Remote Monitoring of Patients With Congestive Heart Failure (CHF) in Central Greece

Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Patients in the control group receive usual care delivered by their primary care physicians and cardiologists. Usual care consists of regular visits to the specialist or primary care clinics every time a medication change is required, or a medical examination is needed.

Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary. If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified.

Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)

Inclusion Criteria: Age ≥ 65 years. Discharge from hospital after acute heart failure in the previous 3 months and FE < 40% or FE > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization Exclusion Criteria: Comorbidities prevalent on CHF with life expectation < 12 months. Inability to use the equipment and help at home not available. Myocardial infarction or percutaneous coronary intervention in the last 3 months. Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled. Being on waiting list for heart transplantation. Being enrolled in other trial.

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"The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community"