Hearing Loss Clinical Trial
Official title:
Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.
| Verified date | July 2023 |
| Source | Region Skane |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 100 |
| Est. completion date | November 2026 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Audiologimottagningen Lund | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Region Skane | Horselvarden Region Ostergotland |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Subjective impact of the intervention, reported by the users: Memory of the intervention | The participants are asked what they remember from their intervention. | 6 months post intervention | |
| Other | Subjective impact of the intervention, reported by the users: Seeking more or other information | The participants are asked if they searched for more or other information about hearing or hearing aids. | 6 months post intervention | |
| Other | Subjective impact of the intervention, reported by the users: Adverse effects | The participants are asked if they experienced any adverse effects of the intervention. | 6 months post intervention | |
| Primary | 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 | 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. | |
| Secondary | 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. | |
| Secondary | 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. |
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