Validation of a quality of life assessment for spina bifida in Dutch
Validation of the Quality of Life Assessment in Spina Bifida for Children and Adolescents in Dutch
This study is testing a new questionnaire in Dutch to see how spina bifida affects the quality of life for children, teens, and adults with the condition compared to those without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Groningen and 1 other locations) |
| Trial ID | NCT06723951 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Quality of Life Assessment for Spina Bifida (QUALAS) in Dutch for children, teenagers, and adults diagnosed with spina bifida. The study will involve a multicenter prospective validation cohort, comparing the quality of life of patients with spina bifida to a control group without the condition. The QUALAS questionnaires specifically address bladder and bowel dysfunction, which are significant factors affecting quality of life in these patients. By validating these assessments in Dutch, the study seeks to enhance the understanding of how spina bifida impacts patients' lives and improve clinical care.
Who should consider this trial
Good fit: Ideal candidates include children aged 8-17 years and adults diagnosed with spina bifida who are fluent in Dutch.
Not a fit: Patients with neurogenic diseases other than spina bifida or those who have had recent surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated tool for assessing and improving the quality of life for patients with spina bifida.
How similar studies have performed: Previous studies have successfully validated similar quality of life assessments in other languages, indicating a promising approach for this validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient group: * Male or female patients aged 8 -12 years (QUALAS-C) * Male or female patients aged 13 - 17 years (QUALAS-T) * Adult patients (QUALAS-A) * Has spina bifida * Adult or child and at least one parent fluent in the Dutch language * Signed informed consent Control group: * Male or female children aged 8 -12 years (QUALAS-C) * Male or female adolescents aged 13 - 17 years (QUALAS-T) * Adults (QUALAS-A) * Has no spina bifida * Adult or child and at least one parent fluent in the Dutch language * Signed informed consent Exclusion Criteria: * Has a neurogenic disease other than spina bifida * Has had surgery in the last month
Where this trial is running
Groningen and 1 other locations
- Umcg — Groningen, Netherlands (Not_yet_recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Lisette 't Hoen, MD, PhD — Erasmus Medical Center
- Study coordinator: Lisette 't Hoen, MD, PhD
- Email: l.thoen@erasmusmc.nl
- Phone: 0031107030073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.