Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT) (RCT)

November 28, 2023 updated by: Milijana Malmberg, Sodra Alvsborgs Hospital

Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial

Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.

The purpose of this project is to offer remote hearing aid adjustment as an additional support for new hearing aid users.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

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 Contact

Study Contact Backup

Study Locations

  • Sweden
    • Vastra Gotalandsregion
      • Boras, Vastra Gotalandsregion, Sweden, 501 82
        • Hearing Clinic, Hearing Organization

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • >18 yr of age
  • new hearing aid user

Exclusion Criteria:

  • <18 yr of age
  • experienced hearing aid users

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely.
Device: Remote HA adjustment
The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.
Active Comparator: Control group
Traditional hearing aid adjustment
Other: Traditional hearing aid
Traditional hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)
Time Frame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.
Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome.
Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time Frame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.
Measures subjective hearing loss in four typical hearing situations (subscales). There are six items for each subscale. Each item is answered for "without my hearing aid" and "with my hearing aid". Each item is a statement associated with a percentage of occasions (1%_Never, 12%_Seldom, 25%_Occasionally, 50%_Half-the-time, 75%_Generally, 87%_Almost Always, 99%_Always)
Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.

Collaborators and Investigators

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

Sponsor

Sodra Alvsborgs Hospital

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)

February 1, 2021

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Remote HA-fitting new

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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