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

Tracking Information
First Received Date ^ICMJE	September 8, 2011
Last Updated Date	February 8, 2013
Start Date ^ICMJE	December 2010
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 15, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01495078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 15, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Official Title ^ICMJE	Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	Heart Failure
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Telemonitoring Patients with follow-up telemonitoring Intervention: Procedure: Telemonitoring No Intervention: Non - telemonitoring Patients with usual face follow-up
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	June 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01495078
Other Study ID Numbers ^ICMJE	Proyecto ICOR
Has Data Monitoring Committee	No
Responsible Party	Parc de Salut Mar
Study Sponsor ^ICMJE	Parc de Salut Mar
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Parc de Salut Mar
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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