search
Back to results

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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemonitoring
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring telemonitoring, heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parc de Salut Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemonitoring

Non - telemonitoring

Arm Description

Patients with follow-up telemonitoring

Patients with usual face follow-up

Outcomes

Primary Outcome Measures

Non fatal events
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
Hospital readmission

Full Information

First Posted
September 8, 2011
Last Updated
February 13, 2016
Sponsor
Parc de Salut Mar
search

1. Study Identification

Unique Protocol Identification Number
NCT01495078
Brief Title
Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Acronym
ICOR
Official Title
Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
telemonitoring, heart failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring
Arm Type
Experimental
Arm Description
Patients with follow-up telemonitoring
Arm Title
Non - telemonitoring
Arm Type
No Intervention
Arm Description
Patients with usual face follow-up
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non fatal events
Description
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.
Time Frame
Six months after inclusion of the patient.
Secondary Outcome Measure Information:
Title
Morbid mortality
Time Frame
From telemonitoring (baseline) until six months later
Title
Hospital readmission
Time Frame
From telemonitoring (baseline) until six months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSEP COMIN COLET, MD
Organizational Affiliation
HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs