Remote Monitoring of Chronic Heart Failure in Veneto Region

Regione Veneto

Status

Completed

Conditions

Congestive Heart Failure

Treatments

Procedure: Telemonitoring for patients with Congestive Heart Failure

Study type

Interventional

Funder types

Other

Identifiers

NCT01513993

G. A. 250487-Veneto WP8Cl7

Details and patient eligibility

About

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.

Full description

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.

Enrollment

315 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 65 years.
Discharge from hospital after acute heart failure in the previous 3 months and EF < 40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization

Exclusion criteria

Comorbidities prevalent on CHF with life expectation < 12 months.
Impossibility or inability to use the equipment and help at home not available.
Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.
Coronary artery bypass, valve substitution or correction in the last 6 months.
Being on waiting list for heart transplantation.
Being enrolled in other trial