Sickle Cell DiseaseNCT02608580
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.
A study testing Survey in people with Sickle Cell Disease, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2013to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sickle cell disease patients, beeing admitted in the CHU Brugmann Hospital (Horta site) after having been followed in the Queen Fabiola Children Hospital.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Survey
- Keywords
- pediatric hospital care, adult hospital care, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with sicke cell disease | Other | 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors impacting the quality of transition between the pediatric and adult care system
The factors will be evaluated with a survey (questionnaire to be filled in)
Measured: 1 day at the first scheduled hospital visit within the CHU Brugmann (according to standard of care for adults)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start1 Dec 2013
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Efira, Brugmann University Hospital
- Investigators
- Marie-Agnès Azerad, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608580
- Sponsor's protocol ID
- CHUB-Transition
- Status last verified
- Jul 2018
- First submitted
- 17 Nov 2015
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02608580
- Acronym / sponsor ID
- CHUB-Transition
- Conditions
- Sickle Cell Disease
- Keywords
- pediatric hospital care, adult hospital care, sickle cell disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with sicke cell disease | Other | Other: SurveyAdult 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Sickle cell disease patients, beeing admitted in the CHU Brugmann Hospital (Horta site) after having been followed in the Queen Fabiola Children Hospital.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey | Other | Patients with sicke cell disease |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Agnès Azerad, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Sickle Cell Disease, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.