NCT03148301

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3.1 years

First QC Date

May 8, 2017

Last Update Submit

July 2, 2024

Conditions

Spina Bifida

Outcome Measures

Primary Outcomes (1)

  • Descriptive statistics about life choices

    Descriptive statistics about life choices measured by the answers of the survey of Spina Bifida patients

    1 year

Study Arms (1)

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

Other: Survey

Interventions

SurveyOTHER

Survey

Patients with Spina Bifida

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Spina Bifidat patients that are seen on the consultation or day care unit of UZ Leuven

You may qualify if:

  • Patients diagnosed with Spina Bifida

You may not qualify if:

  • Not able to read or write Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Spinal Dysraphism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

June 1, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2021

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)