Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events.

Detailed Description
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The HERMeS Trial (Heart failure Events reduction with Remote Monitoring and eHealth Support) is a multicenter, prospective, randomized, open label, observational investigator initiated study to assess the effect on cardiovascular mortality and non-fatal heart failure (HF) events of a telemedicine-based comprehensive management program for patients with chronic HF by means of remote daily telemonitoring of signs and symptoms of HF and remote structured follow-up using videoconference. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published. In this study we aim to compare the strategy of providing nurse-based structured follow-up to high-risk chronic HF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nurse-based follow-up health care using videoconference (tele-intervention). The main hypothesis of the study is that daily telemonitoring of clinical variables and symptoms in high-risk patients with HF allows early detection of decompensations by decreasing the number of fatal cardiovascular events or non-fatal HF events. As a secondary hypothesis we assume that tele-intervention using telemedicine may help to optimise neurohormonal treatment and deliver appropriate education to high-risk patients with HF; and delivery of care in high risk patients with HF through the combination of remote monitoring and tele-intervention may translate into a reduction of fatal and non fatal HF-related events.

Official Title
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Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old. Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning. Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria. Written informed consent must be obtained before any assessment is performed. Patients receiving oral standard medication for chronic heart failure (CHF). All patients will be eligible regardless the level of left ventricular ejection fraction (LVEF). Exclusion Criteria: Age<18 years old. Participation in another clinical trial. Moderate or severe cognitive impairment without a competent caregiver. Lack of social support. Institutionalized patients. Life expectancy less than 1 year (excluding HF). Candidates for home-based or institutional end-of-life care. Serious psychiatric illness. Planned cardiac surgery. Planned Heart transplantation or left ventricular assist device (LVAD) implant. Patients in hemodialysis program. Death before hospital discharge. The patient is unable or unwilling to give the informed consent to participate. The patient is considered not to be an adequate candidate for this study according to the decision of the local investigator. Unstable patients with signs of fluid overload or low cardiac output.

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>Structured follow-up in the basis of using telemedicine. Telemedicine will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference. | Procedure: Telemonitoring<br>* The system (the home tele-healthcare platform) designed jointly by engineers and clinical personal to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring. The system allow weekly follow up through videoconferences. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses daily.<br>|
| No Intervention: Usual Care<br>Patients with usual care follow-up in a heart failure program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of cardiovascular death or non-fatal heart failure events. | Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission. | Six months after inclusion of the patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission (all-cause, HF and cardiovascular) rate and total number. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Days in hospital (all-cause, HF and cardiovascular). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Rate of emergency visits. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Rate of non-fatal HF events. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Mortality for any cause and cardiovascular mortality. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Improvement of quality of life using a validated questionnaire (EUROQOL - 5D). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 
| Patient satisfaction using a Likert-type scale. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Telemonitoring, Disease Management, Chronic Care Model, Transitional Care