QUALAS Validation in Dutch

NCT06723951 | Recruiting

• 1 other identifier: EMCSophia2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spina Bifida

Outcome Measures

Primary Outcomes (1)

• Internal consistency of QUALAS

  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.

  3 months

Secondary Outcomes (3)

• Reproducibility

  2 weeks

• Content validity

  3 months

• Construct validity

  3 months

Study Arms (6)

Children with spina bifida

• Male or female aged 8 -12 years with spina bifida

Other: QUALAS survey

Control group children

• Male or females aged 8 -12 years without spina bifida

Other: QUALAS survey

Teenagers with spina bifida

• Males or female aged 13 - 17 years with spina bifida

Other: QUALAS survey

Control group teenagers

• Males or females aged 13 - 17 years without spina bifida

Other: QUALAS survey

Adults with spina bifida

Adults with spina bifida

Other: QUALAS survey

Control group adults

Adults without spina bifida

Other: QUALAS survey

Interventions

QUALAS survey OTHER

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

Also known as: KIDSCREEN survey for children and teenagers, World Health Organization Quality of Life instrument (WHOQOL-BREF) and (International Consultation on Incontinence Questionnaire) ICIQ for adults

Adults with spina bifida; Children with spina bifida; Control group adults; Control group children; Control group teenagers; Teenagers with spina bifida

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Parents of children and children and adults with spina bifida that are patients at the Urology department of the two hospitals will be approached to participate. This questionnaire quantifies the quality of life in patients with spina bifida, with a special interest in bladder and bowel dysfunction. A group of children and adults without spina bifida will function as a control group. These children and adults will be approached at the ENT and paediatric clinics.

You may qualify if:

• 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

You may not qualify if:

• Has a neurogenic disease other than spina bifida
• Has had surgery in the last month

Sponsors & Collaborators

• Erasmus Medical Center: lead
• University Medical Center Groningen: collaborator

Study Sites (2)

UMCG

Groningen, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lisette 't Hoen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisette 't Hoen, MD, PhD

CONTACT

0031107030073; l.thoen@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 9, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)