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

Sponsor

Horselvarden Region Ostergotland (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05815667

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

37.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Impairment	Behavioral: Individualised Active Communication Education (I-ACE)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Communication and Acceptance Scale (CAS) [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.
Communication Strategies Scale (CSS) [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.
The Hearing Handicap Inventory for the Elderly (HHIE) [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.

Secondary Outcome Measures

The International Outcome Inventory for Alternative Interventions (IOI-AI) [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.
The International Outcome Inventory for Hearing Aids (IOI-HA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hörselvården Region Östergötland	Linköping		Sweden

Sponsors and Collaborators

Horselvarden Region Ostergotland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Horselvarden Region Ostergotland

ClinicalTrials.gov Identifier:

NCT05815667

Other Study ID Numbers:

IAK RCT

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hearing Loss

Deafness

Study Results

No Results Posted as of Apr 18, 2023