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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hearing Loss, Hearing Impairment, Hearing Disorders, Hearing Disability, Ear Diseases, Sensation Disorders, Otorhinolaryngologic Diseases

Intervention / Treatment
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* Behavioral: Online hearing support for first-time hearing aid users
* Behavioral: Hearing rehabilitation according to common practice.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants get hearing rehabilitation according to common practice and the online hearing support. | Behavioral: Online hearing support for first-time hearing aid users<br>* 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.<br>* Other names: Internetbaserat stöd vid hörselrehabilitering;|
| Active Comparator: Control group<br>Participants get hearing rehabilitation according to common practice. | Behavioral: Hearing rehabilitation according to common practice.<br>* Participants get hearing rehabilitation according to common practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12) | 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) | 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) | 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. |