NCT06051968

Brief Summary

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
Sep 2023Nov 2026

First Submitted

Initial submission to the registry

September 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

September 18, 2023

Last Update Submit

April 10, 2025

Conditions

Hearing LossHearing ImpairmentHearing DisordersHearing DisabilityEar DiseasesSensation DisordersOtorhinolaryngologic Diseases

Outcome Measures

Primary Outcomes (1)

  • The Hearing Handicap Inventory for the Elderly (HHIE)

    Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.

    Baseline, directly post intervention and 6 months post intervention.

Secondary Outcomes (3)

  • The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)

    Baseline, directly post intervention and 6 months post intervention.

  • Communication Strategies Scale (CSS)

    Baseline, directly post intervention and 6 months post intervention.

  • The International Outcome Inventory for Hearing Aids (IOI-HA)

    Directly post intervention and 6 months post intervention.

Other Outcomes (3)

  • Subjective impact of the intervention, reported by the users: Memory of the intervention

    6 months post intervention

  • Subjective impact of the intervention, reported by the users: Seeking more or other information

    6 months post intervention

  • Subjective impact of the intervention, reported by the users: Adverse effects

    6 months post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants get hearing rehabilitation according to common practice and the online hearing support.

Behavioral: Online hearing support for first-time hearing aid users

Control group

ACTIVE COMPARATOR

Participants get hearing rehabilitation according to common practice.

Behavioral: Hearing rehabilitation according to common practice.

Interventions

Online hearing support for first-time hearing aid usersBEHAVIORAL

Participants get hearing rehabilitation according to common practice and the online hearing support consists of five chapters that aim to give information, support, and advice to the new hearing aid users. The participants are assigned a new chapter between each visit at the clinic.

Also known as: Stöd och Behandling för nya hörapparatanvändare, Internetbaserat stöd vid hörselrehabilitering
Intervention group
Hearing rehabilitation according to common practice.BEHAVIORAL

Participants get hearing rehabilitation according to common practice.

Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 20 years of age that are eligible for hearing aids
  • Access to a computer, tablet and/or smartphone with internet
  • Access to a Swedish BankID or equivalent

You may not qualify if:

  • Inability to read and understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Audiologimottagningen Lund

Lund, Sweden

Location

MeSH Terms

Conditions

Hearing LossHearing DisordersEar DiseasesSensation DisordersOtorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Öberg

    Horselvarden Region Ostergotland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

September 18, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)