Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Hospital Universitari de Bellvitge
- Enrollment
- 510
- Locations
- 1
- Primary Endpoint
- Occurrence of cardiovascular death or non-fatal heart failure events.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Josep Comín
Head of the Community Heart Failure Unit, Cardiology Department. MD, PhD
Hospital Universitari de Bellvitge
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Occurrence of cardiovascular death or non-fatal heart failure events.
Time Frame: Six months after inclusion of the patient
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.
Secondary Outcomes
- Days in hospital (all-cause, HF and cardiovascular).(Six months after inclusion of the patient.)
- Rate of emergency visits.(Six months after inclusion of the patient.)
- Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).(Six months after inclusion of the patient.)
- Mortality for any cause and cardiovascular mortality.(Six months after inclusion of the patient.)
- Readmission (all-cause, HF and cardiovascular) rate and total number.(Six months after inclusion of the patient.)
- Rate of non-fatal HF events.(Six months after inclusion of the patient.)
- Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).(Six months after inclusion of the patient.)
- Patient satisfaction using a Likert-type scale.(Six months after inclusion of the patient.)