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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495078
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Josep Comín, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Telemonitoring Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Study Start Date : December 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Telemonitoring
Patients with follow-up telemonitoring
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.

No Intervention: Non - telemonitoring
Patients with usual face follow-up

Primary Outcome Measures :
  1. Non fatal events [ Time Frame: 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 :
  1. Morbid mortality [ Time Frame: From telemonitoring (baseline) until six months later ]
  2. Hospital readmission [ Time Frame: From telemonitoring (baseline) until six months later ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01495078

Parc de Salut Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar

Responsible Party: Josep Comín, Josep Comin-Colet, Parc de Salut Mar Identifier: NCT01495078     History of Changes
Other Study ID Numbers: Proyecto ICOR
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Josep Comín, Parc de Salut Mar:
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases