Hearing LossNCT04122183
Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening
A study testing iManage (my hearing loss) in people with Hearing Loss, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to see if a newly developed program called "I Manage my hearing loss" (iManage) will increase the number of individuals who visit an audiologist after failing a hearing screening. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- iManage (my hearing loss)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 30 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must fail a hearing screening (any threshold >34 decibels hearing level at 2000 or 3000 Hertz in either ear) or show equivalent or greater degree of hearing loss on most recent audiogram.
- Free of obvious outer or middle ear disease (as measured by otoscopy)
- Between the ages of 45 and 85
- Pass a health literacy screening
- Pass a thinking skills screening
Who cannot join
- Experience seeing an audiologist for a hearing evaluation or management
- Experience using a hearing aid
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville, Program in Audiology
Louisville, Kentucky, 40202
About this study
Official title: Internet Auditory Rehabilitation: Innovative Follow-up to Adult Hearing Screening.
The purpose of this study is to see if a newly developed program called "I Manage my hearing loss" (iManage) will increase the number of individuals who visit an audiologist after failing a hearing screening. The iManage program will educate individuals about hearing loss, demonstrate that hearing problems are important, demonstrate that support from family and friends is important and help participants identify the benefits and concerns related to seeking help for hearing loss.
- Conditions
- Hearing Loss
- Being tested
- iManage (my hearing loss)
- Keywords
- Hearing Screening, Auditory Rehabilitation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iManage (my hearing loss)Other
An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.
| Study group | Role | What they receive |
|---|---|---|
| Program Group | Experimental | Following a failed hearing screening, participants will be offered the standard of care (information sheet recommending a comprehensive hearing evaluation) and asked to complete the iManage Program. Six months after the screening participants will be asked if they visited an audiologist. Receives: Other: iManage (my hearing loss) |
| Delayed Program Group | No intervention | Following a failed hearing screening, participants will be offered the standard of care (information sheet recommending a comprehensive hearing evaluation). Six months after the screening participants will be asked if they visited an audiologist and they will be given the opportunity to complete the iManage Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiologist visit
The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.
Measured: 6 months following the failed hearing screening
Secondary outcomes (3)
Change on the Health Belief Questionnaire, a survey that measures attitudes about the 6 constructs of the Health Belief Model as related to seeking hearing healthcare
Mean score (which can range between 1 and 11) on each of 6 scales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, perceived self-efficacy, and cues to action. A higher score indicates greater agreement with the construct.
Measured: Baseline (within one week of screening) and 6 months post baseline
Change on the Readiness for Change Questionnaire, a single-item questionnaire that attempts to place the participant on a continuum regarding readiness for hearing healthcare as outline by the Transtheoretical Model.
Participants will select the statement that best describes their view of their hearing status, 1 indicates "precontemplation", 2 indicates "contemplation", 3 indicates, "preparation", 4 indicates "action" on the Transtheoretical Model Continuum.
Measured: Baseline, 4 weeks post baseline, and 6 months post baseline
Total score on the Hearing Loss Support Scale, a questionnaire that measures self-perceived informational and emotional support from family, peers, and healthcare providers about managing hearing loss.
Total score can range between 7 and 49, with a higher score indicating greater support from others.
Measured: Baseline, and 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start17 Aug 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- William Demant Foundation (Formerly known as the Oticon Foundation)
- Responsible party
- Principal investigator, Laura N. Galloway, University of Louisville
- Investigators
- Laura Galloway, AuD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122183
- Sponsor's protocol ID
- 15.0663
- Status last verified
- Jul 2024
- First submitted
- 8 Oct 2019
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no individual participant data (IPD) sharing plan at this time as this is a feasibility study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Auditory Rehabilitation: Innovative Follow-up to Adult Hearing Screening.
- ClinicalTrials.gov ID
- NCT04122183
- Acronym / sponsor ID
- 15.0663
- Conditions
- Hearing Loss
- Keywords
- Hearing Screening, Auditory Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- William Demant Foundation (Formerly known as the Oticon Foundation)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 Oct 2019 (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.
The purpose of this study is to see if a newly developed program called "I Manage my hearing loss" (iManage) will increase the number of individuals who visit an audiologist after failing a hearing screening. The iManage program will educate individuals about hearing loss, demonstrate that hearing problems are important, demonstrate that support from family and friends is important and help participants identify the benefits and concerns related to seeking help for hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program Group | Experimental | Other: iManage (my hearing loss)Following a failed hearing screening, participants will be offered the standard of care (information sheet recommending a comprehensive hearing evaluation) and asked to complete the iManage Program. Six months after the screening participants will be asked if they visited an audiologist. |
| Delayed Program Group | No intervention | –Following a failed hearing screening, participants will be offered the standard of care (information sheet recommending a comprehensive hearing evaluation). Six months after the screening participants will be asked if they visited an audiologist and they will be given the opportunity to complete the iManage Program. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must fail a hearing screening (any threshold >34 decibels hearing level at 2000 or 3000 Hertz in either ear) or show equivalent or greater degree of hearing loss on most recent audiogram.
- Free of obvious outer or middle ear disease (as measured by otoscopy)
- Between the ages of 45 and 85
- Pass a health literacy screening
- Pass a thinking skills screening
Key exclusion criteria (2 listed)
- Experience seeing an audiologist for a hearing evaluation or management
- Experience using a hearing aid
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 |
|---|---|---|
| iManage (my hearing loss)An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist. | Other | Program Group |
Primary outcome
Audiologist visit
Time frame: 6 months following the failed hearing screening
The percentage of individuals who visit an audiologist for a comprehensive hearing evaluation.
3 secondary outcomes
Change on the Health Belief Questionnaire, a survey that measures attitudes about the 6 constructs of the Health Belief Model as related to seeking hearing healthcare
Time frame: Baseline (within one week of screening) and 6 months post baseline
Change on the Readiness for Change Questionnaire, a single-item questionnaire that attempts to place the participant on a continuum regarding readiness for hearing healthcare as outline by the Transtheoretical Model.
Time frame: Baseline, 4 weeks post baseline, and 6 months post baseline
Total score on the Hearing Loss Support Scale, a questionnaire that measures self-perceived informational and emotional support from family, peers, and healthcare providers about managing hearing loss.
Time frame: Baseline, and 6 months post baseline
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 29 Jul 2024.
- Individual participant dataSharing planned: No. There is no individual participant data (IPD) sharing plan at this time as this is a feasibility study.
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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.
Laura Galloway, AuD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iManage (my hearing loss) in people with Hearing Loss, run by University of Louisville at 1 site in United States.
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 5 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 29 Jul 2024. 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 United States. 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?
Audiologist visit (time frame: 6 months following the failed hearing screening). 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 29 Jul 2024.