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Completed

NCT Number: NCT05815667

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

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.

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Key information

Conditions

Hearing Impairment Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hörselvården Region Östergötland

Linköping, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualised Active Communication Education (I-ACE)

Behavioral

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.

Primary outcomes

  1. 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

  1. Communication Strategies Scale (CSS)

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

    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.

  2. The Hearing Handicap Inventory for the Elderly (HHIE)

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

    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.

  3. The International Outcome Inventory for Hearing Aids (IOI-HA)

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

    Assessing changes in perceived effectiveness and satisfaction with hearing aids.

    Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.

  4. The International Outcome Inventory for Alternative Interventions (IOI-AI)

    Time frame: Directly post intervention and 6 months post intervention.

    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.

Sponsors and collaborators

Lead sponsor

Horselvarden Region Ostergotland

Other

Registry information

Official study title

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

Acronym: I-ACE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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