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Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools) (KIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123497
Recruitment Status : Unknown
Verified March 2020 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : April 21, 2017
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:
Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment

Condition or disease Intervention/treatment
Idiopathic Thrombocytopenic Purpura Other: completion of questionnaire

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 183 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Idiopathic Thrombocytopenic Purpura
completion of questionnaire
 Other: completion of questionnaire
completion of questionnaire for patient and parent


Outcome Measures
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Primary Outcome Measures :
  1. quality of life score according to type of treatment [ Time Frame: at inclusion visit ]
    quality of life score according to type of treatment


Secondary Outcome Measures :
  1. number of hospitalisation and consults per year [ Time Frame: at inclusion visit ]
    number of hospitalisation and consults per year

  2. description of general quality of life [ Time Frame: at inclusion visit ]
    use ped'sQL general

  3. description of general quality of life [ Time Frame: at inclusion visit ]
    use ped'sQL fatigue

  4. description of awareness of parent and patient about Idiopathic thrombocytopenic purpura [ Time Frame: at inclusion visit ]
    use Kid's ITO Tools questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123497


Contacts
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Contact: marianne roumy 0241356385 ext +33 marianne.roumy@chu-angers.fr

Locations
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France
CHU d'Angers Recruiting
Angers, France, 49933
Contact: Marianne Roumy    0241356385 ext +33    marianne.roumy@chu-angers.fr   
Principal Investigator: Isabelle Pellier, Pr         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Isabelle Pellier, Pr chu
More Information
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Additional Information:

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03123497    
Other Study ID Numbers: 49RC17_0011
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
Idiopathic Thrombocytopenic Purpura
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
 Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases