Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
ICOR
1 other identifier
interventional
178
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Dec 2010
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 17, 2016
February 1, 2016
2.5 years
September 8, 2011
February 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Six months after inclusion of the patient.
Secondary Outcomes (2)
Morbid mortality
From telemonitoring (baseline) until six months later
Hospital readmission
From telemonitoring (baseline) until six months later
Study Arms (2)
Telemonitoring
EXPERIMENTALPatients with follow-up telemonitoring
Non - telemonitoring
NO INTERVENTIONPatients with usual face follow-up
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parc de Salut Mar
Barcelona, Spain, 08003, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JOSEP COMIN COLET, MD
HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Josep Comin-Colet
Study Record Dates
First Submitted
September 8, 2011
First Posted
December 19, 2011
Study Start
December 1, 2010
Primary Completion
June 1, 2013
Study Completion
December 1, 2014
Last Updated
February 17, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share