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 study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
315
Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms.
Azienda Ospedaliera di Padova - Cardiology Department
Padova, Padova, Italy
Ospedale Immacolata Concezione - Cardiology Department
Piove di Sacco, Padova, Italy
Presidio ospedaliero di Conegliano - Department of Cardiology
Conegliano, Treviso, Italy
Combined end point of all cause mortality and number of hospitalisations for heart failure
Time frame: 12 months
Cardiovascular and all-cause mortality
Time frame: 12 months
Health-Related Quality of Life
Health-Related Quality of Life is assessed by the SF-36 questionnaire
Time frame: 12 months
Number of hospitalisations (including rehospitalisations) for all causes and for heart failure
Time frame: 12 months
Total number of days in hospital
Time frame: 12 months
Number of specialist visits
Time frame: 12 months
Number of visits at emergency department for heart failure
Time frame: 12 months
Anxiety and depression status
Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale Ca'Foncello - Pulmonology Department
Treviso, Treviso, Italy
Ospedale di Mirano - Cardiology Department
Mirano, Venezia, Italy
Ospedale SS Giovanni e Paolo - Cardiology Department
Venezia, Venezia, Italy
Ospedale San Fracastoro - Cardiology Department
San Bonifacio, Verona, Italy
Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department
Verona, Verona, Italy