Clinically Implementing Online Hearing Support Within Hearing Organization

Hearing Impairment Clinical Trial

Official title:

Clinically Implementing Online Hearing Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687801
• Other study ID #: e-Hearing
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: August 16, 2019

Study information

• Verified date: September 2019
• Source: Sodra Alvsborgs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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").

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 16, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Behavioral:
• Online hearing support
The intervention group will follow an online hearing support for five weeks
• Standard care
The control group will follow standard care during the time the intervention group receives online haring support

Locations

Country	Name	City	State
Sweden	Hearing Clinic, Hearing Organization	Boras	Vastra Gotalandsregion

Sponsors (1)

Lead Sponsor	Collaborator
Sodra Alvsborgs Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change is assessed for the Hearing Handicap Inventory for the Elderly (HHIE)	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	Change is assessed for the Communication Strategies Scale (CSS)	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