Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Telemonitoring

• Registration Number: NCT01495078
• Lead Sponsor: Parc de Salut Mar

Brief Summary

The primary objective of the study is to determine the effect of automated daily selfreported symptom and weight, blood pressure and heart rate monitoring and clinical follow-up videoconference comigrate with clinical follow-up face in specialized hospital unit in reducing heart failure non-fatal events.

Detailed Description

The insuficie 'ncia Cardı´aca Optimitzacio ´ Remota (iCOR; Heart Failure Remote Optimization) trial was a singlecentre, randomized, open-label study designed to evaluate the efficacy of the addition of telemedicine (telemonitorization and teleintervention using videoconference) to an existing specialized, multidisciplinary, nurse-based, hospitalprimary care integrated HF programme for high-risk patients with CHF. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.2 In this study we aimed to compare the strategy of providing nurse-based structured follow-up to high-risk CHF 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 in our HF programme) 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 nursebased follow-up health care using videoconference (teleintervention). The main hypothesis of this study was that adding telemedicine to an existing HF programme would be associated with a reduction in the number of non-fatal HF events in high-risk patients with CHF. As a secondary hypothesis we assumed that adding telemedicine would translate into a reduction in health care resource utilization and subsequently in health care costs.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Primary Completion: 2013-06
• Study Completion: 2014-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-13
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study.

Exclusion Criteria

• Less than 18 years
• Long-term nursing home residence, irreversible medical conditions, Folstein Mini-mental State Exam score less than 20.
• No access to 3G line, currently scheduled for cardiac transplant, left ventricular assist device or valvular surgery,coronary intervention within 90 days of randomisation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Telemonitoring	Patients with follow-up telemonitoring

Primary Outcome Measures

Name	Time	Method
Non fatal events	Six months after inclusion of the patient.	Non fatal events are defined as an event of descompensation requiring either parenteral treatment as outpatients in a day hospital an in the emergency department or by income.

Secondary Outcome Measures

Name	Time	Method
Morbid mortality	From telemonitoring (baseline) until six months later
Hospital readmission	From telemonitoring (baseline) until six months later

Trial Locations

Locations (1)

Parc de Salut Mar; 🇪🇸 Barcelona, Spain