Hearing ImpairmentI-ACENCT05815667
Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in FTU
A study testing Individualised Active Communication Education (I-ACE) in people with Hearing Impairment, run by Horselvarden Region Ostergotland at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Individualised Active Communication Education (I-ACE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2023to 16 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who have participated in Active Communication Education prior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hearing Impairment
- Being tested
- Individualised Active Communication Education (I-ACE)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised Active Communication Education (I-ACE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | I-ACE. All participants are offered the I-ACE programme for the duration of 5 weeks. Receives: Behavioral: Individualised Active Communication Education (I-ACE) |
| Control group | No intervention | Waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, directly post intervention and 6 months post intervention.
Secondary outcomes (4)
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.
Measured: Baseline, directly post intervention and 6 months post intervention.
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.
Measured: Baseline, directly post intervention and 6 months post intervention.
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.
Measured: Baseline, directly post intervention and 6 months post intervention.
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.
Measured: Directly post intervention and 6 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2023
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horselvarden Region Ostergotland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815667
- Sponsor's protocol ID
- IAK RCT
- Acronym
- I-ACE
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Swedish Internet-based Individualised Active Communication Education (I-ACE) in First Time Hearing Aid Users: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05815667
- Acronym / sponsor ID
- I-ACE / IAK RCT
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Horselvarden Region OstergotlandUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Individualised Active Communication Education (I-ACE)I-ACE. All participants are offered the I-ACE programme for the duration of 5 weeks. |
| Control group | No intervention | –Waiting list. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who have participated in Active Communication Education prior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
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.
4 secondary outcomes
Communication Strategies Scale (CSS)
Time frame: 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.
The International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: Baseline, directly post intervention and 6 months post intervention.
The International Outcome Inventory for Alternative Interventions (IOI-AI)
Time frame: Directly post intervention and 6 months post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised Active Communication Education (I-ACE) in people with Hearing Impairment, run by Horselvarden Region Ostergotland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication and Acceptance Scale (CAS) (time frame: Baseline, directly post intervention and 6 months post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.