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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Josep Comín, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01495078
First received: September 8, 2011
Last updated: February 13, 2016
Last verified: February 2016

September 8, 2011
February 13, 2016
December 2010
June 2013   (final data collection date for primary outcome measure)
Non fatal events [ Time Frame: Six months after inclusion of the patient. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01495078 on ClinicalTrials.gov Archive Site
  • Morbid mortality [ Time Frame: From telemonitoring (baseline) until six months later ] [ Designated as safety issue: No ]
  • Hospital readmission [ Time Frame: From telemonitoring (baseline) until six months later ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Heart Failure
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.

  • Experimental: Telemonitoring
    Patients with follow-up telemonitoring
    Intervention: Procedure: Telemonitoring
  • No Intervention: Non - telemonitoring
    Patients with usual face follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
December 2014
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01495078
Proyecto ICOR
No
No
Not Provided
Josep Comín, Parc de Salut Mar
Parc de Salut Mar
Not Provided
Principal Investigator: JOSEP COMIN COLET, MD HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
Parc de Salut Mar
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP