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Survey in a Population of Sickle Cell Disease Patients to Evaluate the Transition Between the Queen Fabiola Children Hospital and the CHU Brugmann Hospital, and the Quality of the Hospital Care Within the CHU Brugmann Hospital.

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ClinicalTrials.gov Identifier: NCT02608580
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Andre Efira, Brugmann University Hospital

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date July 12, 2018
Actual Study Start Date  ICMJE December 1, 2013
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
Factors impacting the quality of transition between the pediatric and adult care system [ Time Frame: 1 day at the first scheduled hospital visit within the CHU Brugmann (according to standard of care for adults) ]
The factors will be evaluated with a survey (questionnaire to be filled in)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survey in a Population of Sickle Cell Disease Patients to Evaluate the Transition Between the Queen Fabiola Children Hospital and the CHU Brugmann Hospital, and the Quality of the Hospital Care Within the CHU Brugmann Hospital.
Official Title  ICMJE Survey in a Population of Sickle Cell Disease Patients to Evaluate the Transition Between the Queen Fabiola Children Hospital and the CHU Brugmann Hospital, and the Quality of the Hospital Care Within the CHU Brugmann Hospital.
Brief Summary

Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin.The anomaly has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility to infections.

Patients with this disease should be monitored medically continuously from birth. At adulthood, they will pass from a pediatric medical care system to an adult medical care system.This transition can be experienced with more or less ease, depending on the organization within the pediatric and adult hospitals.

This questionnaire aims to assess the quality of the transition between pediatric and adult services.The investigators want to better estimate hospital work and improve the quality of care for this type of patients, throughout their entire medical history.

Detailed Description

Sickle cell disease is a genetic disease responsible for an abnormal hemoglobin. It particularly affects populations with an African ascent (300 000 African children are born every year with this genetic anomaly).

The anomaly has several consequences: a low hemoglobin rate (chronic anemia), plugs formed by red blood cells in blood vessels (extremely painful vaso-occlusive crises) and greater susceptibility to infections.

The severity of sickle cell disease is variable among children. Some develop frequent and serious complications, while others don't. A child with sickle cell disease is hospitalized about a week a year in average (for a painful crisis, infection or worsening of anemia).

Patients with this disease should be monitored medically continuously from birth. At adulthood, they will pass from a pediatric medical care system to an adult medical care system.This transition can be experienced with more or less ease, depending on the organization within the pediatric and adult hospitals.

This questionnaire aims to assess the quality of the transition between pediatric and adult services.The investigators want to better estimate hospital work and improve the quality of care for this type of patients throughout their entire medical history.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Other: Survey
Study Arms  ICMJE Patients with sicke cell disease

Adult sickle cell disease patients will fill in a survey about the quality of their hospital care, in the transition period between the pediatric to an adult hospital care system.

Since filling in this survey is not part of the standard of care, this study has been defined as interventional.

Intervention: Other: Survey
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
50
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sickle cell disease patients, beeing admitted in the CHU Brugmann Hospital (Horta site) after having been followed in the Queen Fabiola Children Hospital.

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608580
Other Study ID Numbers  ICMJE CHUB-Transition
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  ICMJE Not Provided
Current Responsible Party Andre Efira, Brugmann University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brugmann University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie-Agnès Azerad, MD CHU Brugmann
PRS Account Brugmann University Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP