RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- Regione Veneto
- Enrollment
- 315
- Locations
- 8
- Primary Endpoint
- Combined end point of all cause mortality and number of hospitalisations for heart failure
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Combined end point of all cause mortality and number of hospitalisations for heart failure
Time Frame: 12 months
Secondary Outcomes
- Number of hospitalisations (including rehospitalisations) for all causes and for heart failure(12 months)
- Number of specialist visits(12 months)
- Total number of days in hospital(12 months)
- Number of visits at emergency department for heart failure(12 months)
- Cardiovascular and all-cause mortality(12 months)
- Health-Related Quality of Life(12 months)
- Anxiety and depression status(12 months)