How Parents, Children, and Clinicians Experience Digital Health Tools in Pediatric Audiology

NCT06943976 | Not Yet Recruiting

• 1 other identifier: 13562
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to understand how children with hearing loss, their parents, and health care providers experience digital health questionnaires that are completed before audiology follow-up appointments. The study focuses on children and adolescents (aged 7-18 years old) with hearing loss, and their parents, visiting the Audiology outpatient clinic of the Erasmus MC Sophia Children's Hospital. The main questions it aims to answer are:

• How do parents, children, and clinicians experience digital questionnaires like the HEAR-QL before an audiology visit?
• Do these digital tools help improve communication and preparation for the appointment? Participants will:
• Be invited to complete a short feedback questionnaire about their experience with digital tools
• Share their views on how helpful or relevant the questionnaires were
• Health care providers will also give feedback on how they use and interpret the responses in clinical care

Conditions

Hearing Loss, Bilateral or Unilateral

Keywords

Hearing Loss; Quality of Life; PROMs; PREMs; Children; Digital Health Care

Outcome Measures

Primary Outcomes (1)

• Experience with digital health questionnaires

  Experience scores from a custom feedback survey completed by parents/caregivers and children aged 7-18 years, evaluating clarity, relevance, and burden of digital questionnaires.

  Within 3 months after the audiology appointment

Secondary Outcomes (1)

• Clinician-perceived utility of digital questionnaires

  Within the time frame of the patient enrollment

Eligibility Criteria

• Age: 7 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from the population of children and adolescents aged 7 to 18 years with unilateral or bilateral hearing loss who attend the Audiology outpatient clinic of Erasmus MC Sophia Children's Hospital in Rotterdam, the Netherlands. Their parents or primary caregivers will also be invited to participate. Additionally, audiologists and other health care professionals working at the same clinic and using patient-reported outcome measures (PROMs) in routine care will be included in the study.

You may qualify if:

• Children and adolescents, aged 7-18 years old, with rehabilitated unilateral or bilateral hearing loss, attending the Audiology outpatient clinic of the Erasmus MC Sophia Children's Hospital in Rotterdam, the Netherlands
• The corresponding parents or caregivers of these pediatric patients
• Audiologists or other health care providers who systematically use the PROMs during patient interactions at the same Audiology outpatient clinic.

You may not qualify if:

• Children or adolescents who are unable to complete the questionnaire, even with support in reading and understanding the items provided by their parents or caregivers.

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident and PhD Candidate in Otorhinolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04