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Clinical Trials in the Netherlands / NCT06723951
Recruiting Observational

QUALAS Validation in Dutch

NCT06723951 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Observational
Started
2024-12-09
Last updated
2024-12-12

Condition(s) studied

Spina Bifida

Investigational drug(s) / intervention(s)

QUALAS survey

QUALAS survey: Participants will be asked to complete the surveys at one (controls) and two (patients) timepoints.

Study summary

Rationale Patients with spina bifida often experience a decreased quality of life compared to patients without spina bifida. The Quality of Life Assessment for Spina Bifida (QUALAS) is a validated questionnaire to assess the quality of life in children, teenagers and adults with spina bifida, accounting for specific factors, such as bladder and bowel dysfunction. This questionnaire enables us to assess the current spina bifida related quality of life and identify if bladder and bowel dysfunction is of influence.

Objective(s) To validate the Quality of Life Assessment for Spina Bifida in Children, Teenagers and Adults in Dutch.

Study type A multicenter prospective validation cohort study.

Study population Children aged 8 - 17 years and adults who are diagnosed with spina bifida. As a control group children aged 8 - 17 years and adults without spina bifida will be approached at the Ear-Nose-Throat (ENT) and paediatric clinics.

Methods The main study parameter is the validation of the Dutch version of the questionnaire. Patients with spina bifida are asked to fill out the QUALAS at two time-points. They are also asked to fill out an extra questionnaire at two time-points, in order to validate the QUALAS. Children and adults in the control groups are asked to fill out the two questionnaires only once.

Burden and risks No (extra) outpatient visit is required. The questions in the questionnaires are similar to the medical history during an outpatient visit. The burden is therefore minimal for these patients. Participation in this study will not influence patient treatment.

Recruitment and consent Parents of children and children and adults who meet the inclusion criteria and none of the exclusion criteria will be informed orally about this study by their treating urologist during a regular visit. A patient information and consent form will be handed over to the parents and children over eight years of age and adults. Parents of children and children and adults at the ENT clinic will be approached by the local urologist for participation for this study. If they are willing to participate they will be asked to sign informed consent and fill out the questionnaire.

Eligibility

Sex
ALL
Min age
8 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Internal consistency of QUALAS — 3 months
    Internal consistency is the main study endpoint. This will be calculated with Cronbach's alpha. Values between 0.70 and 0.95 reflect good consistency. QUALAS questionnaire: Scores range from 0-100 with higher scores indicating better quality of life.

Trial sites (2)

FacilityCityRegionStatus
UMCG Groningen Netherlands Not Yet Recruiting
Erasmus MC Rotterdam Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06723951 on ClinicalTrials.gov ↗ ← All trials in the Netherlands