Anti Vitamin K Therapeutic Education
Sponsor
University Hospital, Montpellier (Other)
Overall Status
Terminated
CT.gov ID
NCT01587053
Collaborator
(none)
57
1
58.1
1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
57 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years
Actual Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Feb 1, 2017
Actual Study Completion Date
:
Feb 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AVK patient with AVK treatment |
Other: therapeutic education program
|
Outcome Measures
Primary Outcome Measures
- INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) [up to 1 year]
Secondary Outcome Measures
- Quality of life questionnaire [2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: Pascal AMEDRO, MD, PhD, Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01587053
Other Study ID Numbers:
- 8745
First Posted:
Apr 27, 2012
Last Update Posted:
Dec 2, 2020
Last Verified:
Nov 1, 2020