Follow Up of an Online Hearing Support for First-time Hearing Aid Users
NCT Number: NCT06468137
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss|Hearing Impairment|Hearing Disorders
Interventions: BEHAVIORAL: Swedish I-ACE|BEHAVIORAL: Clinical visit|OTHER: No follow-up
Sponsor: Region Skane
Collaborators: Horselvarden Region Ostergotland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: Audiologimottagningen Lund, Lund, Sweden

Summary:
The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.

Primary Outcome Measures: 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, about 7 weeks post choice of intervention, and 6 months post intervention
Secondary Outcome Measures: 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, about 7 weeks post choice of 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, about 7 weeks post choice of 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., Baseline, about 7 weeks post choice of intervention, and 6 months post intervention|Communication and Acceptance Scale (CAS), Assessing changes in use of communication strategies and the emotional consequences, knowledge and acceptance of hearing loss. Minimum 18 points to maximum 90. Higher score indicates a lower impact of the hearing loss., Baseline, about 7 weeks post choice of intervention, and 6 months post intervention|The International Outcome Inventory for Alternative Interventions (IOI-AI), Assessing changes in perceived effectiveness and satisfaction with an alternative intervention, in this case the Swedish I-ACE.

Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect., Baseline, about 7 weeks post choice of intervention, and 6 months post intervention
Other Outcome Measures: Subjective impact of the intervention, reported by the users: Memory of the intervention, The participants are asked what they remember from their intervention., Time Frame: 6 months post intervention|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., Time Frame: 6 months post intervention|Subjective impact of the intervention, reported by the users: Adverse effects, The participants are asked if they experienced any adverse effects of the intervention., Time Frame: 6 months post intervention