Spina BifidaNCT03148301
Spina Bifida in Daily Life: an Exploratory Study
An observational study of Spina Bifida, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is know about the daily impact of spina bifida on participation possibilities in social life. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Survey
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2017to 30 Jun 2021
- Phase
- Observational
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Spina Bifidat patients that are seen on the consultation or day care unit of UZ Leuven
Who may be able to join
- Patients diagnosed with Spina Bifida
Who cannot join
- Not able to read or write Dutch
Trial locations and contacts
1 site in 1 country.
About this study
Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is know about the daily impact of spina bifida on participation possibilities in social life. This exploratory research project want to investigate which lif choices patients with spina bifida has to make and in which way their daily life is organized. In a second part, quality of life will be measured and we hope to discover some dynamics in order to improve patient care.
Read the detailed description
This exploratory research project wants to investigate how patients with spina bifida live their daily life and which impact spina bifida has on their choices of life. This will be done by a survey that will ask questions about different domains in life: demographic variables, education, work, social functioning, spare time, housing, mobility, independency and quality of life. The survey is based on empirical findings in literature. The quality of life questioning is based on the SF36. The survey will be done once during a clinical consultation.
- Conditions
- Spina Bifida
- Being tested
- Survey
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey
| Study group | Role | What they receive |
|---|---|---|
| Patients with Spina Bifida | Adults with and parents of children with Spina Bifida followed by the team in UZ Leuven will be asked to complete a survey Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistics about life choices
Descriptive statistics about life choices measured by the answers of the survey of Spina Bifida patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jun 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148301
- Sponsor's protocol ID
- S60433
- Status last verified
- Jul 2024
- First submitted
- 8 May 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spina Bifida in Daily Life: an Exploratory Study
- ClinicalTrials.gov ID
- NCT03148301
- Acronym / sponsor ID
- S60433
- Conditions
- Spina Bifida
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 May 2017 (actual)
- 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.
Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is know about the daily impact of spina bifida on participation possibilities in social life. This exploratory research project want to investigate which lif choices patients with spina bifida has to make and in which way their daily life is organized. In a second part, quality of life will be measured and we hope to discover some dynamics in order to improve patient care.
Detailed description
This exploratory research project wants to investigate how patients with spina bifida live their daily life and which impact spina bifida has on their choices of life. This will be done by a survey that will ask questions about different domains in life: demographic variables, education, work, social functioning, spare time, housing, mobility, independency and quality of life. The survey is based on empirical findings in literature. The quality of life questioning is based on the SF36. The survey will be done once during a clinical consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Spina Bifida | – | Other: SurveyAdults with and parents of children with Spina Bifida followed by the team in UZ Leuven will be asked to complete a survey |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spina Bifidat patients that are seen on the consultation or day care unit of UZ Leuven
Key inclusion criteria (1 listed)
- Patients diagnosed with Spina Bifida
Key exclusion criteria (1 listed)
- Not able to read or write Dutch
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 |
|---|---|---|
| SurveySurvey | Other | Patients with Spina Bifida |
Primary outcome
Descriptive statistics about life choices
Time frame: 1 year
Descriptive statistics about life choices measured by the answers of the survey of Spina Bifida patients
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 3 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida, run by Universitaire Ziekenhuizen KU Leuven 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 3 Jul 2024. 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?
Descriptive statistics about life choices (time frame: 1 year). 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 3 Jul 2024.