Remote Monitoring of Chronic Heart Failure in Veneto Region
- Conditions
- Congestive Heart Failure
- Interventions
- Procedure: Telemonitoring for patients with Congestive Heart Failure
- Registration Number
- NCT01513993
- Lead Sponsor
- Regione Veneto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring for patients with Congestive Heart Failure Telemonitoring for patients with Congestive Heart Failure -
- Primary Outcome Measures
Name Time Method Combined end point of all cause mortality and number of hospitalisations for heart failure 12 months
- Secondary Outcome Measures
Name Time Method Number of hospitalisations (including rehospitalisations) for all causes and for heart failure 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 Health-Related Quality of Life is assessed by the SF-36 questionnaire
Anxiety and depression status 12 months Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)
Number of specialist visits 12 months
Trial Locations
- Locations (8)
Ospedale di Mirano - Cardiology Department
🇮🇹Mirano, Venezia, Italy
Azienda Ospedaliera di Padova - Cardiology Department
🇮🇹Padova, Italy
Ospedale Immacolata Concezione - Cardiology Department
🇮🇹Piove di Sacco, Padova, Italy
Presidio ospedaliero di Conegliano - Department of Cardiology
🇮🇹Conegliano, Treviso, Italy
Ospedale SS Giovanni e Paolo - Cardiology Department
🇮🇹Venezia, Italy
Ospedale Ca'Foncello - Pulmonology Department
🇮🇹Treviso, Italy
Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department
🇮🇹Verona, Italy
Ospedale San Fracastoro - Cardiology Department
🇮🇹San Bonifacio, Verona, Italy