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Clinical Trials/NCT05815667
NCT05815667
Completed
Not Applicable

Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in First Time Hearing Aid Users: a Randomised Controlled Trial.

Horselvarden Region Ostergotland1 site in 1 country63 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Impairment
Sponsor
Horselvarden Region Ostergotland
Enrollment
63
Locations
1
Primary Endpoint
Communication and Acceptance Scale (CAS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Hearing impairment affects the ability to communicate, which can adversely affect both mental and physical health. The most common used rehabilitation method in hearing impairment is hearing aid fitting. Even with optimally fitted hearing aids, many struggle to hear in situations with difficult listening conditions. Active Communication Education (ACE) is an interactive group rehabilitation programme aiming to help those with hearing loss communicate more effectively using communication strategies to cope better in everyday life. An Individualised Active Communication Education (I-ACE) distributed digitally could enable those unable to get to the hearing care facility, or don't want to join the group sessions to benefit from the programme.

This project aims to investigate the effects of the swedish digital version of the I-ACE in first time hearing aid users.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 16, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Horselvarden Region Ostergotland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults \>20 years old who have been fitted with hearing aids for the first time (first time users) 6 - 12 months prior.
  • Computer experience and access to computer, tablet and/or smartphone with internet access.
  • Access to BankID or equivalent.

Exclusion Criteria

  • Those who have participated in Active Communication Education prior.

Outcomes

Primary Outcomes

Communication and Acceptance Scale (CAS)

Time Frame: Baseline, directly post intervention and 6 months post intervention.

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.

Secondary Outcomes

  • Communication Strategies Scale (CSS)(Baseline, directly post intervention and 6 months post intervention.)
  • The Hearing Handicap Inventory for the Elderly (HHIE)(Baseline, directly post intervention and 6 months post intervention.)
  • The International Outcome Inventory for Hearing Aids (IOI-HA)(Baseline, directly post intervention and 6 months post intervention.)
  • The International Outcome Inventory for Alternative Interventions (IOI-AI)(Directly post intervention and 6 months post intervention.)

Study Sites (1)

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