NCT03663907

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2018-05-15
• Primary completion: 2022-10-25
• Completion: 2022-10-25
• First posted: 2018-09-10
• Last updated: 2022-10-26

Locations

1 site across 1 country: Spain