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

Primary Purpose

Hearing Impairment

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Individualised Active Communication Education (I-ACE)
Sponsored by
Horselvarden Region Ostergotland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Impairment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hörselvården Region Östergötland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Waiting list.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 21, 2023
Last Updated
April 4, 2023
Sponsor
Horselvarden Region Ostergotland
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1. Study Identification

Unique Protocol Identification Number
NCT05815667
Brief Title
Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in FTU
Acronym
I-ACE
Official Title
Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in First Time Hearing Aid Users: A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horselvarden Region Ostergotland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
I-ACE. All participants are offered the I-ACE programme for the duration of 5 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waiting list.
Intervention Type
Behavioral
Intervention Name(s)
Individualised Active Communication Education (I-ACE)
Intervention Description
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 Outcome Measure Information:
Title
Communication and Acceptance Scale (CAS)
Description
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.
Time Frame
Baseline, directly post intervention and 6 months post intervention.
Title
Communication Strategies Scale (CSS)
Description
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.
Time Frame
Baseline, directly post intervention and 6 months post intervention.
Title
The Hearing Handicap Inventory for the Elderly (HHIE)
Description
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.
Time Frame
Baseline, directly post intervention and 6 months post intervention.
Secondary Outcome Measure Information:
Title
The International Outcome Inventory for Alternative Interventions (IOI-AI)
Description
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.
Time Frame
Directly post intervention and 6 months post intervention.
Title
The International Outcome Inventory for Hearing Aids (IOI-HA)
Description
Assessing changes in perceived effectiveness and satisfaction with hearing aids. Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Time Frame
Baseline, directly post intervention and 6 months post intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hörselvården Region Östergötland
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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