Hearing LossNCT02839759
Hearing Aid Education and Adaptation System
A study testing TELLYHealth in people with Hearing Loss, run by Healthcare Technologies and Methods, LLC at 2 sites in United States.
Trial summary
This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- TELLYHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2018to 30 Apr 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speaks and reads English fluently
- Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss
- Will be fitted with one or two hearing aids at the time of enrollment
- Owns a standard TV
- Has Internet access at home
- Has sufficient corrected vision to watch videos and read text on the TV and mobile device
- No signs of dementia
Who cannot join
- Lives with person who has enrolled in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clear Sound Audiology
Gainesville, Florida, 32605
Potomac Audiology
Rockville, Maryland, 20852
About this study
Official title: Interactive Technology for Hearing Aid Education and Acceptance
This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.
Read the detailed description
HTM will develop the "TELLYHealth (tm) system" that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.
- Conditions
- Hearing Loss
- Being tested
- TELLYHealth
- Keywords
- Hearing loss, Presbycusis, Aging, Teleaudiology
- Medical subject headings
- Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELLYHealthOther
Educational videos and questions.
| Study group | Role | What they receive |
|---|---|---|
| TELLYHealth Group | Experimental | Subjects will receive the standard of care in hearing aid education and the TELLYHealth intervention for use over an 8 to12-week period and will be followed by their audiologist for 8 to 12 weeks. Receives: Other: TELLYHealth |
| Standard of Care Group | No intervention | Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Inventory for the Elderly (HHIE)
Pre-post changes in the HHIE total scores
Measured: 8-12 weeks
Secondary outcomes (1)
Communication Scale for Older Adults (CSOA)
Pre-post changes in the CSOA communication strategies \& attitudes scores
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start31 Aug 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthcare Technologies and Methods, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Alan M Letzt, M.S., Principal investigator, Healthcare Technologies and Methods, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839759
- Sponsor's protocol ID
- HTM092016
- Other IDs
- R44AG045947
- Status last verified
- May 2020
- First submitted
- 15 Jul 2016
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated data on hearing aid education will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Technology for Hearing Aid Education and Acceptance
- ClinicalTrials.gov ID
- NCT02839759
- Acronym / sponsor ID
- HTM092016
- Conditions
- Hearing Loss
- Keywords
- Hearing loss, Presbycusis, Aging, Teleaudiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Healthcare Technologies and Methods, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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.
This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.
Detailed description
HTM will develop the "TELLYHealth (tm) system" that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TELLYHealth Group | Experimental | Other: TELLYHealthSubjects will receive the standard of care in hearing aid education and the TELLYHealth intervention for use over an 8 to12-week period and will be followed by their audiologist for 8 to 12 weeks. |
| Standard of Care Group | No intervention | –Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Speaks and reads English fluently
- Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss
- Will be fitted with one or two hearing aids at the time of enrollment
- Owns a standard TV
- Has Internet access at home
Key exclusion criteria (1 listed)
- Lives with person who has enrolled in the study
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 |
|---|---|---|
| TELLYHealthEducational videos and questions. | Other | TELLYHealth Group |
Primary outcome
Hearing Handicap Inventory for the Elderly (HHIE)
Time frame: 8-12 weeks
Pre-post changes in the HHIE total scores
1 secondary outcome
Communication Scale for Older Adults (CSOA)
Time frame: 8-12 weeks
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 14 May 2020.
- Individual participant dataSharing planned: Yes. Aggregated data on hearing aid education will be shared.
Related trials for Hearing Loss
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Hearing Loss
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Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
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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.
Alan M Letzt, M.S. principal investigator
Healthcare Technologies and Methods, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TELLYHealth in people with Hearing Loss, run by Healthcare Technologies and Methods, LLC at 2 sites 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 7 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hearing Handicap Inventory for the Elderly (HHIE) (time frame: 8-12 weeks). 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 14 May 2020.