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NCT06051968 Clinical Trial

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

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06051968
Other study ID # 2023-01633-02
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 18, 2023
Est. completion date November 2026

Study information
Verified date July 2023
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Online hearing support for first-time hearing aid users
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.
• Hearing rehabilitation according to common practice.
Participants get hearing rehabilitation according to common practice.

Locations
Country Name City State
Sweden Audiologimottagningen Lund Lund

Sponsors (2)
Lead Sponsor Collaborator
Region Skane Horselvarden Region Ostergotland

Country where clinical trial is conducted

Sweden, 

Outcome
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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