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

April 4, 2023 updated by: Horselvarden Region Ostergotland

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden
        • Horselvarden Region Ostergotland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
I-ACE. All participants are offered the I-ACE programme for the duration of 5 weeks.
Behavioral: Individualised Active Communication Education (I-ACE)
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.
No Intervention: Control group
Waiting list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, directly post intervention and 6 months post intervention.
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.
Baseline, directly post intervention and 6 months post intervention.
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.
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)
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.
Directly post intervention and 6 months post intervention.
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.
Baseline, directly post intervention and 6 months post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horselvarden Region Ostergotland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAK RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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