Spina Bifida in Daily Life: an Exploratory 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.

Study Overview

• Status: Unknown
• Conditions: Spina Bifida
• Intervention / Treatment: Other: Survey

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sam Geuens, MSc; Phone Number: 91 +32 16 34 19; Email: sam.geuens@uzleuven.be
• Study Contact Backup: Name: Dr Katrien Jansen, PhD; Phone Number: 18 +32 16 34 98; Email: katrien.jansen@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: sam Geuens; Email: sam.geuens@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Patients diagnosed with Spina Bifida

Exclusion Criteria:

• Not able to read or write Dutch

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive statistics about life choices	Descriptive statistics about life choices measured by the answers of the survey of Spina Bifida patients	1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: S60433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No