Hearing ImpairmentNCT05936320
Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation
A study testing Information leaflets with illustrations about hearing aid functions and Information leaflets with only text about hearing aid functions in people with Hearing Impairment, run by Horselvarden Region Ostergotland at 1 site in Sweden.
Trial summary
Knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Information leaflets with illustrations about hearing aid functions and Information leaflets with only text about hearing aid functions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2020to 16 May 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-80 years old) with hearing aids from 2012 or later
Who cannot join
- Hearing aids without possibility to have activated directional microphones and telecoil
- non-swedish speaking (e.g. need interpreter)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Hearing Clinic of the University Hospital Region Ostergotland
Linköping, Östergötland County, 58185
About this study
Official title: A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations
Knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. Information leaflets is a common tool in healthcare to give information with the purpose to increase theoretical knowledge and change behaviour, and illustrations in these leaflets can provide additional understanding for all kinds of patients.
The primary aim of this aural rehabiliation study was to evaluate participants' knowledge about placement in a noisy environment, directional microphone and telecoil function at baseline and postintervention and assessing their perceptions of the benefits of an information leaflet. Additional aim was to investigate whether, an information leaflet with illustrations and accompanying text about hearing aid functions have additional effects on participants' knowledge compared to an information leaflet without illustrations.
- Conditions
- Hearing Impairment
- Being tested
- Information leaflets with illustrations about hearing aid functions, Information leaflets with only text about hearing aid functions
- Keywords
- aural rehabilitation, hearing aid functions, hearing aid knowledge, information leaflet, visual aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information leaflets with illustrations about hearing aid functionsBehavioural
The information leaflet contains written information with simple illustrations about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.
Information leaflets with only text about hearing aid functionsBehavioural
The information leaflet contains written information about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Verbal information along with information leaflets containing text with illustrations about hearing aid functions Receives: Behavioral: Information leaflets with illustrations about hearing aid functions |
| Control group | Experimental | Verbal information along with information leaflets containing text-only about hearing aid functions Receives: Behavioral: Information leaflets with only text about hearing aid functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about hearing aid functions
Assessing change in knowledge about placement in noisy environments, telecoil function and directional microphones.
Open-ended questions where the knowledge assessed by two authors independently of each other, to make the answers quantitative. Interrater reliability was analysed with Cohen's kappa
Measured: Baseline, 3 weeks postintervention
Perceived benefit
Assessing the perceived benefit of the information leaflet through three items formulated as statements and ranged from (0) not agree at all to (10) completely agree.
The statements were as follows: 1) the written information I received has increased my understanding of the functions of the hearing aid, and 2) the written information I received has made me better understand how to position myself in different sound environments. If applicable, 3) the written information I received made it easier for me to explain the functions of my hearing aid to a communication partner.
Measured: 3 weeks postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start25 Feb 2020
- Primary completion16 May 2022
- Study completion16 May 2022
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horselvarden Region Ostergotland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Öberg, Principal investigator, Horselvarden Region Ostergotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936320
- Sponsor's protocol ID
- Bildstöd
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 7 Jul 2023
- 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 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations
- ClinicalTrials.gov ID
- NCT05936320
- Acronym / sponsor ID
- Bildstöd
- Conditions
- Hearing Impairment
- Keywords
- aural rehabilitation, hearing aid functions, hearing aid knowledge, information leaflet, visual aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Horselvarden Region OstergotlandUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 7 Jul 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.
Knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. Information leaflets is a common tool in healthcare to give information with the purpose to increase theoretical knowledge and change behaviour, and illustrations in these leaflets can provide additional understanding for all kinds of patients.
The primary aim of this aural rehabiliation study was to evaluate participants' knowledge about placement in a noisy environment, directional microphone and telecoil function at baseline and postintervention and assessing their perceptions of the benefits of an information leaflet. Additional aim was to investigate whether, an information leaflet with illustrations and accompanying text about hearing aid functions have additional effects on participants' knowledge compared to an information leaflet without illustrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Information leaflets with illustrations about hearing aid functionsVerbal information along with information leaflets containing text with illustrations about hearing aid functions |
| Control group | Experimental | Behavioral: Information leaflets with only text about hearing aid functionsVerbal information along with information leaflets containing text-only about hearing aid functions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (18-80 years old) with hearing aids from 2012 or later
Key exclusion criteria (2 listed)
- Hearing aids without possibility to have activated directional microphones and telecoil
- non-swedish speaking (e.g. need interpreter)
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 |
|---|---|---|
| Information leaflets with illustrations about hearing aid functionsThe information leaflet contains written information with simple illustrations about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes. | Behavioural | Intervention group |
| Information leaflets with only text about hearing aid functionsThe information leaflet contains written information about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes. | Behavioural | Control group |
Primary outcome
Knowledge about hearing aid functions
Time frame: Baseline, 3 weeks postintervention
Assessing change in knowledge about placement in noisy environments, telecoil function and directional microphones. Open-ended questions where the knowledge assessed by two authors independently of each other, to make the answers quantitative. Interrater reliability was analysed with Cohen's kappa
Perceived benefit
Time frame: 3 weeks postintervention
Assessing the perceived benefit of the information leaflet through three items formulated as statements and ranged from (0) not agree at all to (10) completely agree. The statements were as follows: 1) the written information I received has increased my understanding of the functions of the hearing aid, and 2) the written information I received has made me better understand how to position myself in different sound environments. If applicable, 3) the written information I received made it easier for me to explain the functions of my hearing aid to a communication partner.
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 7 Jul 2023.
- 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.
Marie Öberg principal investigator
Horselvarden Region Ostergotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information leaflets with illustrations about hearing aid functions and Information leaflets with only text about hearing aid functions 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 1 inclusion and 2 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 7 Jul 2023. 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?
Knowledge about hearing aid functions (time frame: Baseline, 3 weeks postintervention). The study lists 2 primary outcomes in all. 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 7 Jul 2023.