Clinical trial NCT03663907: Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
Official title: Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Telemedicine
Telemonitoring
Disease Management
Chronic Care Model
Transitional Care
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
First posted: 2018-09-10
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.
* 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.

Primary outcomes:
measure: Occurrence of cardiovascular death or non-fatal heart failure events.
timeFrame: Six months after inclusion of the patient
Secondary outcomes:
measure: Readmission (all-cause, HF and cardiovascular) rate and total number.
timeFrame: Six months after inclusion of the patient.
measure: Days in hospital (all-cause, HF and cardiovascular).
timeFrame: Six months after inclusion of the patient.
measure: Rate of emergency visits.
timeFrame: Six months after inclusion of the patient.
measure: Rate of non-fatal HF events.
timeFrame: Six months after inclusion of the patient.
measure: Mortality for any cause and cardiovascular mortality.
timeFrame: Six months after inclusion of the patient.
measure: Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale).
timeFrame: Six months after inclusion of the patient.
measure: Improvement of quality of life using a validated questionnaire (EUROQOL - 5D).
timeFrame: Six months after inclusion of the patient.
measure: Patient satisfaction using a Likert-type scale.
timeFrame: Six months after inclusion of the patient.
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: University Hospital Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Josep Comín Colet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: