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

NCT05815667 | Completed

• 1 other identifier: IAK RCT
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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 Arms (2)

Intervention group

EXPERIMENTAL

I-ACE. All participants are offered the I-ACE programme for the duration of 5 weeks.

Behavioral: Individualised Active Communication Education (I-ACE)

Control group

NO INTERVENTION

Waiting list.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those who have participated in Active Communication Education prior.

Sponsors & Collaborators

• Horselvarden Region Ostergotland: lead

Study Sites (1)

Hörselvården Region Östergötland

Linköping, Sweden

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 18, 2023
• Study Start: March 1, 2023
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)