NCT07798453

Brief Summary

The objective of the current research project is to investigate the effectiveness of communication training in first-time hearing aid users with mild to moderate hearing loss delivered in-person in groups or individually. In doing so, the project aims to strengthen evidence-based person-centered care for individuals with hearing loss and pave the path toward more holistic hearing healthcare. We hypothesize that participants receiving communication training will show improved hearing-related quality of life, communication strategies, and personal adjustment compared to controls. Moreover, group training is expected to yield greater benefits in communication strategies and adjustment than individual training, due to its interactive nature and peer support, leading to more positive evaluations in interviews. A pretest-posttest design will be used, with testing before and after the communication training sessions, and two experimental groups and a control group. The two experimental groups are the groups receiving in-person group and individual training. The control group does not receive the communication training nor an alternative. A mixed-method will be applied to collect quantitative and qualitative data. The quantitative data include screening measures, audiological tests, and questionnaires, while the qualitative data consist of a semi-structured interview.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

November 14, 2025

Last Update Submit

August 27, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Hearing related quality of life questionnaire

    Higher scores mean a better outcome.

    Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).

  • International Outcome Inventory for Hearing Aids Questionnaire

    Higher scores mean a better outcome.

    Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).

  • Hearing Attitudes in Rehabilitation Questionnaire

    Higher scores mean a worse outcome.

    Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).

  • Hearing Handicap Inventory for the Elderly Screening Questionnaire

    Higher scores mean a worse outcome.

    Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).

  • Communication Profile for the Hearing Impaired Questionnaire

    Higher scores mean a better outcome.

    Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).

  • Interview about training

    This outcome measure will be assessed once: once during the post testing (+/- 7 to 8 weeks after the baseline).

Study Arms (3)

Control group

OTHER

The control group does not receive the communication training nor an alternative.

Behavioral: Cognitive screeningBehavioral: Audiological AssessmentBehavioral: QuestionnairesBehavioral: Communication trainingOther: Interview

Group with individual communication training

EXPERIMENTAL

The individuals receive individual training.

Behavioral: Cognitive screeningBehavioral: Audiological AssessmentBehavioral: QuestionnairesBehavioral: Communication trainingOther: Interview

Group with group communication training

EXPERIMENTAL

The individuals receive group training.

Behavioral: Cognitive screeningBehavioral: Audiological AssessmentBehavioral: QuestionnairesBehavioral: Communication trainingOther: Interview

Interventions

The Dutch Montreal Cognitive Assessment will be assessed.

Control groupGroup with group communication trainingGroup with individual communication training

1. Tympanometry 2. Otoscopy 3. Pure-tone audiometry 4. Speech audiometry in quiet and in noise

Control groupGroup with group communication trainingGroup with individual communication training
QuestionnairesBEHAVIORAL

5 questionnaires are included (Dutch translation): 1. The hAVICOP questionnaire to assess the hearing-related quality of life for Auditory-Visual, Cognitive and Psychosocial functioning 2. The Revised Hearing Handicap Inventory for Adults (RHHI-A) 3. The Communication Profile for the Hearing Impaired (CPHI) 4. The Hearing Attitudes in Rehabilitation Questionnaire (HARQ) 5. The International OutcomeInventory for Hearing Aids (IOI-HA)

Control groupGroup with group communication trainingGroup with individual communication training

The participant will take part in two training sessions. Depending on the assigned group, this will take place individually or in a group setting. During the training, challenges commonly faced by people with hearing loss will be discussed, and strategies to communicate more effectively will be introduced.

Control groupGroup with group communication trainingGroup with individual communication training

A semi-structured one-on-one interviews will be conducted. Participants in the group and individual training will be asked about the feasibility, usability, and effectiveness of the training they attended. Participants in the control group, who did not receive training, will be asked about their expectations regarding a communication training.

Control groupGroup with group communication trainingGroup with individual communication training

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dutch speaking first-time hearing aid users between 45-80 years
  • Individuals with mild-to-moderate sensorineural hearing loss
  • Individuals with bilateral hearing aids (minimal 6 months)
  • Individuals who are capable to give consent to participate in the study themselves

You may not qualify if:

  • User of cochlear implants
  • Participants who have previously received auditory, auditory-cognitive, or communication training
  • Participants with a middle ear disorder
  • Participants without age-appropriate cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

PresbycusisHearing Loss, SensorineuralSpeech Intelligibility

Interventions

Mental Status and Dementia TestsSurveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeechVerbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hannah Keppler, Prof. dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

September 1, 2026

Study Start

September 16, 2025

Primary Completion

July 9, 2026

Study Completion

July 9, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations