Clinically Implementing Online Hearing Support Within Hearing Organization

September 17, 2019 updated by: Milijana Malmberg, Sodra Alvsborgs Hospital

Clinically Implementing Online Hearing Support

Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services. Several studies have shown that hearing support can be carried out without in-person meetings and lead to significant benefits for hearing aid users. Interventions for persons with hearing impairment improve communication and improve outcomes more than hearing aid use alone.

The first purpose of this study is needs-oriented and the second purpose is research-oriented. The needs-oriented purpose of this project is to, via a national website of health information and services for Sweden, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, provides ("standard care").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aural rehabilitation The most common approach to hearing impairment is hearing aid fitting as a part of aural rehabilitation (AR). In Sweden, approximately 50% of those who could benefit from hearing aids are fitted with them, and nearly half of those use their hearing aids to a considerable extent every day. Despite addressing the hearing impairment with hearing aids, many hearing aid users experience substantial communication difficulties that can affect their performance in daily life situations. This could cause patients to stop using their hearing aids, which may negatively affect their interpersonal interactions and involvement in community life.

Adjusting to hearing impairment involves more than just hearing aid fitting, although hearing aid fitting is a step in the right direction. Additional steps within AR, such as learning about the condition and providing perceptual training and counseling, need to be included in order to minimize the negative effects of a hearing impairment on social interactions and quality of life. These additional steps can effectively be included variously throughout the AR (separately or in combination, and individually or in groups), they may increase hearing aid use and satisfaction, and can be performed as an adjunct to or a supplement for hearing aid fitting. However, even though combining these additional steps with hearing aid use has proven to be beneficial, most hearing aid users are unaware of and are not offered any other rehabilitation measures than hearing aid fitting. This deficiency could be due to clinicians experiencing lack of time and difficulties scheduling interventions in addition to hearing aid fitting. It could also be due to the presumably increased costs of adding extra support to hearing aid fitting. These aspects could hinder audiologist's in general clinical practice from providing holistic care. Thus, the overall availability of comprehensive AR is low.

Internet interventions Online interventions and healthcare information is cost-effective. Online hearing healthcare has increased in recent years and is empowering for persons with hearing impairment. Telehealth (i.e., telephone and internet) offers a more cost-effective approach to hearing healthcare and increases the possibilities for the audiologist to reach out to persons with hearing impairment. Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services.

Effective internet interventions have four important interactive design features: 1) social context and support, 2) contacts with intervention, 3) tailoring, and 4) self-management. Patient participation is central for self-management to be successful. For example, a person with hearing impairment can apply knowledge obtained in communication training to reduce hearing-related problems. The role of the audiologist in delivering social contact and support, and contacts with the intervention, seems to be of particular importance in online audiology interventions.

Purpose With this project we want to provide online support to hearing aid users. Further on, we want to document the effectiveness of the online support compared to traditional support that the Hearing Organization, VGR, provides ("standard care").

The needs-oriented purpose: The project is a part of a collaboration between 1177 Care-Guide and region Vastra Gotaland (VGR). 1177 Care-Guide is a national website of health information and services for Sweden. Every region customizes its 1177 Care-Guide. Regions use the 1177 Care-Guide platform to provide online services. The needs-oriented purpose of this project is to, via 1177, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, VGR, provides ("standard care"). Traditional support ("standard care") in Sweden differs across and within counties, in particular in terms of the number of visits and the content of comprehensive AR. The costs of amplification for the person with hearing impairment may also vary across counties.

Study Type

Interventional

Enrollment (Actual)

128

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
    • 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the hearing aid users to be 20 yr of age or above,
  • the hearing aid users to have completed a hearing aid fitting at least 3 months before the study began (regardless of hearing aid manufacturer, model, or hearing aid outcomes),
  • the hearing aid users to have a Hearing Handicap Inventory for the Elderly (HHIE) score of >20 points (indicative of some residual self-reported hearing problems).

Exclusion Criteria:

  • the hearing aid users who are not fulfilling the conditions to participate.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online hearing support
The intervention group will have access to online hearing support for five weeks. The online hearing support will include a program that consists of three elements: 1) reading material; 2) reading instructions and weekly assignments related to the reading material; and 3) online and telephone interaction with a professional.
Behavioral: Online hearing support
The intervention group will follow an online hearing support for five weeks
Active Comparator: Standard care
The control group will have access to traditional support that the Hearing Organization provides ("standard care").
Behavioral: Standard care
The control group will follow standard care during the time the intervention group receives online haring support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is assessed for the Hearing Handicap Inventory for the Elderly (HHIE)
Time Frame: change from baseline HHIE at 5 weeks, change from baseline HHIE at 6 months, change from baseline HHIE at 1 year
The HHIE measures the experience of hearing loss in older people by focusing on the psychosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
change from baseline HHIE at 5 weeks, change from baseline HHIE at 6 months, change from baseline HHIE at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is assessed for the Communication Strategies Scale (CSS)
Time Frame: change from baseline CSS at 5 weeks, change from baseline CSS at 6 months, change from baseline CSS at 1 year
CSS (from the Communication Profile for the Hearing Impaired) The CSS is designed to analyze participants' behavior in various communication situations via three subscales: maladaptive behaviors (9 questions that analyze behaviors that hinder communication) and verbal strategies and nonverbal strategies (16 items related to strategies that can enhance communication). The 1 to 5 scoring reflects how frequently a specific situation or behavior occurs.
change from baseline CSS at 5 weeks, change from baseline CSS at 6 months, change from baseline CSS at 1 year

Collaborators and Investigators

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

Sponsor

Sodra Alvsborgs Hospital

Investigators

  • Principal Investigator: Milijana Malmberg, PhD, Hörselverksamheten, Habilitering & Hälsa

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 24, 2018

Primary Completion (Actual)

August 16, 2019

Study Completion (Actual)

August 16, 2019

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • e-Hearing

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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