Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in FTU

Study Overview
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Brief Summary
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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.

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

Conditions
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Hearing Impairment

Intervention / Treatment
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* Behavioral: Individualised Active Communication Education (I-ACE)


Participation Criteria
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Eligibility Criteria
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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.

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>I-ACE. All participants are offered the I-ACE programme for the duration of 5 weeks. | Behavioral: Individualised Active Communication Education (I-ACE)<br>* The swedish I-ACE consists of five modules with different themes, all with sections of information alternated with reflective tasks. The participants are assigned one module each week and provided with weekly feedback from a health care professional on their work, before being assigned the next module.<br>|
| No Intervention: Control group<br>Waiting list. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 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 100. Higher score indicates a greater use of communication strategies. | Baseline, directly post intervention and 6 months post intervention. | 
| The Hearing Handicap Inventory for the Elderly (HHIE) | Assessing changes in emotional and social effects of hearing loss. 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 International Outcome Inventory for Alternative Interventions (IOI-AI) | Assessing changes in perceived effectiveness with an alternative intervention, in this case the I-ACE. Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect. | 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. | Baseline, directly post intervention and 6 months post intervention. |