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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01495078
First received: September 8, 2011
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ]

Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 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

  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
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
  More Information

No publications provided

Responsible Party: 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 8, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by Parc de Salut Mar:
telemonitoring
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013