Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123497
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date April 12, 2017
First Posted Date April 21, 2017
Last Update Posted Date March 12, 2020
Actual Study Start Date April 12, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2017)
quality of life score according to type of treatment [ Time Frame: at inclusion visit ]
quality of life score according to type of treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2017)
  • number of hospitalisation and consults per year [ Time Frame: at inclusion visit ]
    number of hospitalisation and consults per year
  • description of general quality of life [ Time Frame: at inclusion visit ]
    use ped'sQL general
  • description of general quality of life [ Time Frame: at inclusion visit ]
    use ped'sQL fatigue
  • description of awareness of parent and patient about Idiopathic thrombocytopenic purpura [ Time Frame: at inclusion visit ]
    use Kid's ITO Tools questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)
Official Title Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura
Brief Summary Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year
Condition Idiopathic Thrombocytopenic Purpura
Intervention Other: completion of questionnaire
completion of questionnaire for patient and parent
Study Groups/Cohorts Idiopathic Thrombocytopenic Purpura
completion of questionnaire
Intervention: Other: completion of questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 18, 2017)
183
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: marianne roumy 0241356385 ext +33 marianne.roumy@chu-angers.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03123497
Other Study ID Numbers 49RC17_0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Angers
Study Sponsor University Hospital, Angers
Collaborators Not Provided
Investigators
Principal Investigator: Isabelle Pellier, Pr chu
PRS Account University Hospital, Angers
Verification Date March 2020