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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03148301
Other study ID # S60433
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date June 2021

Study information

Verified date November 2018
Source Universitaire Ziekenhuizen Leuven
Contact Sam Geuens, MSc
Phone +32 16 34 19
Email sam.geuens@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2021
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients diagnosed with Spina Bifida

Exclusion Criteria:

- Not able to read or write Dutch

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Survey

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive statistics about life choices Descriptive statistics about life choices measured by the answers of the survey of Spina Bifida patients 1 year
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