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

Heart Failure Clinical Trial

— ICOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495078
• Other study ID #: Proyecto ICOR
• Status: Completed
• Phase: N/A
• First received: September 8, 2011
• Last updated: February 13, 2016
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Telemonitoring
Is a computer system designed jointly by engineers and clinical personal of Parc Salut Mar) to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring . The system allow weekly follow up throught videoconferences. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses.

Locations

Country	Name	City	State
Spain	Parc de Salut Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non fatal events	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.	Six months after inclusion of the patient.	No
Secondary	Morbid mortality		From telemonitoring (baseline) until six months later	No
Secondary	Hospital readmission		From telemonitoring (baseline) until six months later	No