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

The Value of PROMs in Children With Hearing Loss: Patients', Parents' and Healthcare Professionals' Perspectives

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Bilateral or Unilateral

Detailed Description

This observational study evaluates the experiences of children with hearing loss, their parents or caregivers, and audiology health care providers with digital health questionnaires that are completed before pediatric audiology follow-up visits. The study is conducted at the Audiology outpatient clinic of the Erasmus MC Sophia Children's Hospital in Rotterdam, the Netherlands.

As part of routine clinical care, families receive electronic patient-reported outcome measures (PROMs) prior to their appointment, including the Dutch versions of the HEAR-QL questionnaire. These questionnaires are designed to gather insights into the child's hearing-related quality of life and relevant experiences related to hearing care.

Participants in this study include children and adolescents (ages 7-18 years) with unilateral or bilateral hearing loss, their caregivers, and health care professionals (audiologists, speech language pathologists and/or ENT specialists). All participants are invited to provide feedback on the digital questionnaires via brief evaluation surveys (PREMs). This information is collected anonymously and used to understand the usability, relevance, and clinical value of the tools from both the patient and provider perspectives.

Registry-related procedures and quality factors:

• Quality assurance plan: All data are collected using a secure digital platform. Data entry is automated via survey completion, reducing the risk of manual input errors. Registry procedures follow institutional data management standards.
• Data checks and validation: Built-in logic and range checks are applied within the digital survey software to prevent incomplete or inconsistent responses.
• Source data verification: No source data verification is applied, as this study does not use patient medical records beyond the standard demographic and audiological information collected with informed consent.
• Data dictionary: A standardized variable list is maintained, including definitions, coding schemes, and units of measurement. The HEAR-QL scoring methodology is applied as per published validation guidelines.
• Standard Operating Procedures (SOPs): SOPs exist for patient approach, informed consent, survey distribution, data storage, and privacy protection. All procedures align with institutional review board approvals.
• Sample size: The study aims to include a minimum of 50 families (about 80 respondents) over a 4-month period, which is sufficient for descriptive and exploratory analyses of user experience outcomes.
• Missing data: Missing data is not expected, as all questions in the digital questionnaires are required fields. The system prevents submission of incomplete surveys. Therefore, no item-level missingness or imputation procedures are applicable.
• Statistical analysis plan: Quantitative survey responses will be summarized using descriptive statistics (e.g., means, medians, proportions). Associations between user experience scores and patient characteristics (e.g., age, hearing device type) may be explored using nonparametric tests or regression analyses as appropriate. Qualitative comments from participants will be grouped thematically.

This study aims to contribute to the growing body of knowledge on patient and provider experiences with digital health tools in pediatric audiology. Results may inform future implementation and optimization of PROMs in routine hearing care.

• Study Type: Observational
• Enrollment (Estimated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-perceived utility of digital questionnaires	Ratings from audiology/health care staff on the usefulness of digital patient-reported outcome measures (PROMs) in preparing for or guiding the consultation.	Within the time frame of the patient enrollment

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Children; Hearing Loss; PROMs; PREMs; Digital Health Care
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Bilateral
• Other Study ID Numbers: 13562

Drug and device information, study documents

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