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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2022-10-25

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Telemonitoring

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.

Group Type EXPERIMENTAL

Telemonitoring

Intervention Type PROCEDURE

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.

Usual Care

Patients with usual care follow-up in a heart failure program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemonitoring

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No