REMOTE MONITORING OF CHRONIC HEART FAILURE

The sample size for Central Greece (Thessaly) for this cluster is 100 patients for the intervention group, while for the control group will be 50 patients.

Participants are enrolled under the supervision of local principal investigators. In Thessaly, patients are recruited from the outpatient department of the Regional University Hospital of Larisa, and if needed from other hospitals in the region. Participants are included at discharge and until a maximum of three months after discharge. Candidates are informed about the nature and the objectives of the intervention; they are also informed about their random assignment to an intervention or a control group. Once candidates have signed the informed consent form, they are put on the randomisation list.

Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a fully automatic blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. A 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. The nurse (and the allocated physician whenever needed) will provide the appropriate counselling as frequently as necessary. ECG-recording, blood pressure, pulse and body weight will be measured weekly (and whenever symptoms are present); the data will be transmitted to the telemonitoring server and then to the Heart Failure Outpatient Department of the University Hospital of Larissa using web-applications and advanced software. The project will enable interactive tele-consultation and intervention by the cardiologists when required. If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified.

Expected outcomes

The main scope 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.

 

Other cluster of Region of Central Greece: Cluster 2, Cluster 4