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
  Purpose
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 Intervention
Heart Failure
Procedure: Telemonitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 178
Study Start Date: December 2010
Study Completion Date: December 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495078

Locations
Spain
Parc de Salut Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Principal Investigator: JOSEP COMIN COLET, MD HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
  More Information

Responsible Party: Josep Comín, Josep Comin-Colet, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01495078     History of Changes
Other Study ID Numbers: Proyecto ICOR 
Study First Received: September 8, 2011
Last Updated: February 13, 2016
Health Authority: Spain: Ministry of Health

Keywords provided by Parc de Salut Mar:
telemonitoring
heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 26, 2016