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

NCT ID: NCT01495078

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telemonitoring

Patients with follow-up telemonitoring

Group Type: EXPERIMENTAL

Telemonitoring

Intervention Type: PROCEDURE

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.

Non - telemonitoring

Patients with usual face follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Josep Comín

Josep Comin-Colet

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JOSEP COMIN COLET, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE

Locations

Parc de Salut Mar

Barcelona, Spain, Spain

Countries

Spain

Other Identifiers

Proyecto ICOR

Identifier Type: -

Identifier Source: org_study_id