- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03123497
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools) (KIT)
March 11, 2020 updated by: University Hospital, Angers
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura
Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
183
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
-
-
-
Angers, France, 49933
- Recruiting
- CHU d'Angers
-
Principal Investigator:
- Isabelle Pellier, Pr
-
-
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 year to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year
Description
Inclusion Criteria:
- children with Idiopathic thrombocytopenic purpura
- aged between 1 and 17 year
- Idiopathic thrombocytopenic purpura persistent at 12 months
- obtention of informed consent
Exclusion Criteria:
- Persistant/acute Idiopathic thrombocytopenic purpura
- concomittant chronic disease, stabilized or not
- Concomittant disease with life expectancy < 1 year
- Person who have not belong to a social security scheme
- Secondary Idiopathic thrombocytopenic purpura
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 |
---|---|
Idiopathic Thrombocytopenic Purpura
completion of questionnaire
|
completion of questionnaire for patient and parent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life score according to type of treatment
Time Frame: at inclusion visit
|
quality of life score according to type of treatment
|
at inclusion visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of hospitalisation and consults per year
Time Frame: at inclusion visit
|
number of hospitalisation and consults per year
|
at inclusion visit
|
description of general quality of life
Time Frame: at inclusion visit
|
use ped'sQL general
|
at inclusion visit
|
description of general quality of life
Time Frame: at inclusion visit
|
use ped'sQL fatigue
|
at inclusion visit
|
description of awareness of parent and patient about Idiopathic thrombocytopenic purpura
Time Frame: at inclusion visit
|
use Kid's ITO Tools questionnaire
|
at inclusion visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isabelle Pellier, Pr, CHU
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 12, 2017
Primary Completion (ANTICIPATED)
October 1, 2020
Study Completion (ANTICIPATED)
October 30, 2020
Study Registration Dates
First Submitted
April 12, 2017
First Submitted That Met QC Criteria
April 18, 2017
First Posted (ACTUAL)
April 21, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 12, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- 49RC17_0011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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