Hearing LossHERO-EDNCT03053531
Hearing Resources and Outcomes in the Emergency Department (HERO-ED)
A study testing PockeTalker" Hearing Assistive Device (HAD) in people with Hearing Loss, run by NYU Langone Health at 1 site in United States.
Trial summary
The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the HERO-ED Pilot does not involve random assignment (no control group), it will not test device effectiveness. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- PockeTalker" Hearing Assistive Device (HAD)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to 3 Jan 2018
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- low acuity clinical presentation (Emergency Severity Index11 triage criteria of 4 or 5, which indicates a high likelihood of being discharged home from the Emergency Department).
- Patients using hearing aids will not be excluded.
Who cannot join
- Lack of capacity to consent, as defined by the patient's ability to satisfactorily answer the questions outlined in the Evaluation to Sign Consent form (ESC) mentioned in the protocol. A legal representative/family member will not be able to consent for the patient in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Medical Center
New York, New York, 10016
About this study
The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the HERO-ED Pilot does not involve random assignment (no control group), it will not test device effectiveness. However, the HERO-ED Pilot will test device acceptability and use. It will also provide preliminary data on, and allow us to fine-tune, the measures of effectiveness that we plan to use in HERO-ED
Read the detailed description
The objectives are:
- Measure the feasibility of in-ED hearing screening using HHIE-S and a handheld audiometer, among low-acuity11 ED patients age ≥75 years, by quantifying the proportion of eligible patients who complete hearing screening.
- Test whether low-acuity older ED patients who screen positive for significant hearing loss (> 40 dB HL bilaterally and HHIE-S > 24) and are provided a hearing assistance device (HAD) use that device during the ED visit.
- Test whether patients who are given a hearing assistance device will report ability as opposed to disability in hearing and understanding, using a six-item questionnaire adapted from a study by Cox et al.
- Test whether those who are given a hearing assistance device will report being prepared for post-discharge care, using an adapted subset of the Care Transitions Measures (CTM).
- Assess patient understanding of the HAD survey items within the post-use survey.
- Conditions
- Hearing Loss
- Being tested
- PockeTalker" Hearing Assistive Device (HAD)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PockeTalker" Hearing Assistive Device (HAD)Device
Investigators will test impacts of the provision of the HAD on hearing and understanding, and preparation for discharge. Just prior to going home, consented subjects will answer a set of survey questions, using an electronic tablet to support impaired hearing.
| Study group | Role | What they receive |
|---|---|---|
| HERO-ED RCT | Experimental | Subjects will be instructed on use of the HAD. The model that we will use is the PockeTalker Mini-Cog. This is a small (9.0cm X 5.5cm X 2.0cm) battery-powered electronic box that can be worn around the neck which connects via wires to both earphones and headphones (we will supply both earpieces, and let the patient choose). The RA, trained on use of the HAD by an experienced research audiologist, will instruct the patient in use of the HAD, and test the device to ensure proper functioning. The patient will also receive an instruction sheet (Appendix 3). Subjects will be encouraged to use the HAD during any encounters with ED staff. Receives: Device: PockeTalker" Hearing Assistive Device (HAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the feasibility of in-ED hearing screening using HHIE-S
The HHIE-S is a ten-item survey and takes five minutes to complete. Responses to the HHIE reflect the extent to which hearing loss "feels" like a problem. Each response is scored on a 4, 2, or 0 point scale (4 = yes, 2 = sometimes, and 0 = no) for a maximum score of 40. A high score indicates high likelihood of hearing loss. Scores above 24 indicate a high likelihood of hearing loss and high adherence to HAD use
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start3 Feb 2017
- Primary completion30 Nov 2017
- Study completion3 Jan 2018
Why it stopped: Did not meet enrollment
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 NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group study, with no control or comparison group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Chodosh, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053531
- Sponsor's protocol ID
- 16-01171
- Acronym
- HERO-ED
- Status last verified
- Jan 2018
- First submitted
- 3 Feb 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Resources and Outcomes in the Emergency Department (HERO-ED)
- ClinicalTrials.gov ID
- NCT03053531
- Acronym / sponsor ID
- HERO-ED / 16-01171
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not meet enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 15 Feb 2017 (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 Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the HERO-ED Pilot does not involve random assignment (no control group), it will not test device effectiveness. However, the HERO-ED Pilot will test device acceptability and use. It will also provide preliminary data on, and allow us to fine-tune, the measures of effectiveness that we plan to use in HERO-ED
Detailed description
The objectives are:
- Measure the feasibility of in-ED hearing screening using HHIE-S and a handheld audiometer, among low-acuity11 ED patients age ≥75 years, by quantifying the proportion of eligible patients who complete hearing screening.
- Test whether low-acuity older ED patients who screen positive for significant hearing loss (> 40 dB HL bilaterally and HHIE-S > 24) and are provided a hearing assistance device (HAD) use that device during the ED visit.
- Test whether patients who are given a hearing assistance device will report ability as opposed to disability in hearing and understanding, using a six-item questionnaire adapted from a study by Cox et al.
- Test whether those who are given a hearing assistance device will report being prepared for post-discharge care, using an adapted subset of the Care Transitions Measures (CTM).
- Assess patient understanding of the HAD survey items within the post-use survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group study, with no control or comparison group.
| Arm | Type | Receives |
|---|---|---|
| HERO-ED RCT | Experimental | Device: PockeTalker" Hearing Assistive Device (HAD)Subjects will be instructed on use of the HAD. The model that we will use is the PockeTalker Mini-Cog. This is a small (9.0cm X 5.5cm X 2.0cm) battery-powered electronic box that can be worn around the neck which connects via wires to both earphones and headphones (we will supply both earpieces, and let the patient choose). The RA, trained on use of the HAD by an experienced research audiologist, will instruct the patient in use of the HAD, and test the device to ensure proper functioning. The patient will also receive an instruction sheet (Appendix 3). Subjects will be encouraged to use the HAD during any encounters with ED staff. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- low acuity clinical presentation (Emergency Severity Index11 triage criteria of 4 or 5, which indicates a high likelihood of being discharged home from the Emergency Department).
- Patients using hearing aids will not be excluded.
Key exclusion criteria (1 listed)
- Lack of capacity to consent, as defined by the patient's ability to satisfactorily answer the questions outlined in the Evaluation to Sign Consent form (ESC) mentioned in the protocol. A legal representative/family member will not be able to consent for the patient in this 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 |
|---|---|---|
| PockeTalker" Hearing Assistive Device (HAD)Investigators will test impacts of the provision of the HAD on hearing and understanding, and preparation for discharge. Just prior to going home, consented subjects will answer a set of survey questions, using an electronic tablet to support impaired hearing. | Device | HERO-ED RCT |
Primary outcome
Measure the feasibility of in-ED hearing screening using HHIE-S
Time frame: 5 Minutes
The HHIE-S is a ten-item survey and takes five minutes to complete. Responses to the HHIE reflect the extent to which hearing loss "feels" like a problem. Each response is scored on a 4, 2, or 0 point scale (4 = yes, 2 = sometimes, and 0 = no) for a maximum score of 40. A high score indicates high likelihood of hearing loss. Scores above 24 indicate a high likelihood of hearing loss and high adherence to HAD use
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
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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.
Joshua Chodosh principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PockeTalker" Hearing Assistive Device (HAD) in people with Hearing Loss, run by NYU Langone Health 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 2 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: withdrawn, as of the sponsor's last update on 5 Jan 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure the feasibility of in-ED hearing screening using HHIE-S (time frame: 5 Minutes). 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 5 Jan 2018.