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

This study has been completed.
Information provided by (Responsible Party):
Parc de Salut Mar Identifier:
First received: September 8, 2011
Last updated: November 12, 2015
Last verified: November 2015
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01495078

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

No publications provided

Responsible Party: Parc de Salut Mar Identifier: NCT01495078     History of Changes
Other Study ID Numbers: Proyecto ICOR 
Study First Received: September 8, 2011
Last Updated: November 12, 2015
Health Authority: Spain: Ministry of Health

Keywords provided by Parc de Salut Mar:
heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on February 08, 2016