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

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.

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

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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