Remote Monitoring of Chronic Heart Failure in Veneto Region

Study Overview
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Brief Summary
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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
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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.

Official Title
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RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Procedure: Telemonitoring for patients with Congestive Heart Failure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Treatment as usual | |
| Experimental: Telemonitoring for patients with Congestive Heart Failure<br> | Procedure: Telemonitoring for patients with Congestive Heart Failure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined end point of all cause mortality and number of hospitalisations for heart failure |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular and all-cause mortality |  | 12 months | 
| Health-Related Quality of Life | Health-Related Quality of Life is assessed by the SF-36 questionnaire | 12 months | 
| Number of hospitalisations (including rehospitalisations) for all causes and for heart failure |  | 12 months | 
| Total number of days in hospital |  | 12 months | 
| Number of specialist visits |  | 12 months | 
| Number of visits at emergency department for heart failure |  | 12 months | 
| Anxiety and depression status | Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF, Telemonitoring