Anti Vitamin K Therapeutic Education
November 30, 2020 updated by: University Hospital, Montpellier
Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years
The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
57
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France, 34295
- Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children from 0 to 18 years having AVK prescription
Description
Inclusion Criteria:
- age from 0 to 18 years
- AVK prescription
- to accept participating to AVK therapeutic education program
- informed consent form of parents or legal person
Exclusion Criteria:
- parents or legal person refusal to enter in the AVK therapeutic education
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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AVK
patient with AVK treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range)
Time Frame: up to 1 year
|
up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life questionnaire
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pascal AMEDRO, MD, PhD, Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2012
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
April 12, 2012
First Submitted That Met QC Criteria
April 25, 2012
First Posted (Estimate)
April 27, 2012
Study Record Updates
Last Update Posted (Actual)
December 2, 2020
Last Update Submitted That Met QC Criteria
November 30, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8745
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.