Effects of an Online Hearing Support for First-time Hearing Aid Users

October 16, 2023 updated by: Region Skane

Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Audiologimottagningen Lund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to read and understand Swedish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants get hearing rehabilitation according to common practice and the online hearing support.
Behavioral: Online hearing support for first-time hearing aid users
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.
Other Names:
  • Stöd och Behandling för nya hörapparatanvändare
  • Internetbaserat stöd vid hörselrehabilitering
Active Comparator: Control group
Participants get hearing rehabilitation according to common practice.
Behavioral: Hearing rehabilitation according to common practice.
Participants get hearing rehabilitation according to common practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Hearing Handicap Inventory for the Elderly (HHIE)
Time Frame: Baseline, directly post intervention and 6 months post intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
Time Frame: Baseline, directly post intervention and 6 months post intervention.
Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.
Baseline, directly post intervention and 6 months post intervention.
Communication Strategies Scale (CSS)
Time Frame: Baseline, directly post intervention and 6 months post intervention.
Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.
Baseline, directly post intervention and 6 months post intervention.
The International Outcome Inventory for Hearing Aids (IOI-HA)
Time Frame: Directly post intervention and 6 months post intervention.

Assessing changes in perceived effectiveness and satisfaction with hearing aids.

Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Directly post intervention and 6 months post intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective impact of the intervention, reported by the users: Memory of the intervention
Time Frame: 6 months post intervention
The participants are asked what they remember from their intervention.
6 months post intervention
Subjective impact of the intervention, reported by the users: Seeking more or other information
Time Frame: 6 months post intervention
The participants are asked if they searched for more or other information about hearing or hearing aids.
6 months post intervention
Subjective impact of the intervention, reported by the users: Adverse effects
Time Frame: 6 months post intervention
The participants are asked if they experienced any adverse effects of the intervention.
6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Horselvarden Region Ostergotland

Investigators

  • Principal Investigator: Marie Öberg, Horselvarden Region Ostergotland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01633-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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