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Hearing LossNCT02037139

Hearing Health Care Service Access and Use

A study testing Screening, Brochure and Education in people with Hearing Loss, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hearing loss screening rates in for older persons in primary care clinics are very low even though hearing loss is relatively common for older persons. When diagnosed with hearing loss older persons are often reluctant to follow through. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Screening, Brochure and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteUnited States
Study dates
Jul 2013to 15 Sep 2019
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 60 or older
  • Not currently wearing a hearing aid
  • Cognitively capable of giving informed consent
  • Able to speak and understand English
  • No concurrent health problem that would limit participation
  • Screen positive for hearing loss using single question and/or finger rub

Who cannot join

  • Age 59 or less
  • Currently wearing a hearing aid
  • Cognitively impaired or not cognitively capable of giving informed consent
  • Unable to speak and understand English
  • Has a concurrent health condition that limits participation
  • Does not screen positive for hearing loss

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Primary Care Intervention Promoting Hearing Health Care Service Access and Use

Hearing loss screening rates in for older persons in primary care clinics are very low even though hearing loss is relatively common for older persons. When diagnosed with hearing loss older persons are often reluctant to follow through. This study involves a prospective controlled trial comparing the effectiveness of three primary care based protocols for older adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to and use of hearing health care services. The protocols will compare: 1) screening only (standard care control); 2) screening plus an illustrated educational brochure; and 3) screening plus an in-person educational intervention and an illustrated educational brochure. Screening will be done by primary care personnel. Participants will be tracked for 8 months to assess outcomes.

Read the detailed description

The purpose of this study is to evaluate the extent to which hearing health outcomes are improved when patients are screened for hearing loss and provided an educational brochure or screened and provided the brochure plus an educational segment emphasizing points in the brochure versus a standard screening only protocol. These procedures are non-invasive. Hearing loss screening is part of basic health evaluations for older persons, brochures are commonly handed out for a variety of health conditions, and providing patient education is common practice.

At all sites our study research nurse will train clinic staff, contact patients who have indicated they are interested in taking part, obtain informed consent, administer baseline and follow-up questionnaires, and ensure that those completing the two follow-ups receive their gift cards. No information from clinic medical records will be obtained.

Aims:

  1. Evaluate the extent to which hearing health outcomes are improved when patients are screened for hearing loss and provided an educational brochure or screened and provided the brochure plus an educational segment emphasizing points in the brochure versus a standard screening only protocol..
  2. Examine hearing health outcomes by patient and clinic characteristics.
  3. Compare any observed gains in outcomes against the estimated staff time to administer either the brochure or the brochure plus the educational segment.

The three primary outcomes involve comparing the differential impacts of adding an illustrated educational brochure or adding both a brochure and a brief educational segment over screening only. These three outcomes are whether the participant went to see a hearing specialist for an evaluation, whether a hearing or other assistive listening device was obtained if recommended, and whether the device if obtained was being used. Other outcomes include the number of hours a day participants who received assistive devices actually wear them, the number of changes participants have made to improve communication other than obtaining an assistive device, and the extent to which their hearing related quality of life improves.

The primary care clinics taking part in our study already do some screening for hearing loss but often screening is not perceived as leading to better outcomes. The clinics are interested in the opportunity to participate in a project that will assess how effective screening is when combined with additional educational material. All consenting and data collection will be done by our study's Research Nurse.

Specific procedures are:

  1. Older patients coming into the clinic for a medical appointment and who are not wearing hearing aids will be screened by intake personnel (usually a medical assistant or office nurse) for hearing loss using a direct question ("Do you have any difficulty hearing?") and a finger rub test (the finger rub protocol is attached). When either or both of these tests indicate possible hearing loss, intake personnel will tell the patient that their health care provider will be informed and then ask them if they are interested in taking part in a study of hearing loss. Those who express an interest will be asked to fill out contact information on a card for transmission to the study's Research Nurse. They will also be given a flyer describing the study and two copies of the consent to take with them to review and discuss with the study's research nurse. A stamped return envelope will be included for mailing the signed consent after discussing the study with the Research Nurse. The envelope will have the study address both on the front and in the space for the return address in order to protect patient confidentiality. One of three protocols will then occur for those indicating an interest in the study:
  • For the first 28 patients the intake personnel will take no further action other than to provide the screening results to the patient's health care provider.
  • For the next 28 patients the intake personnel will hand them the brochure For the last 28 patients the intake personnel will hand them the brochure and then ask if it is all right with them if he/she goes over some points in the brochure.
  1. Training for the finger rub and what to do during the three protocols will be conducted by the study's Research Nurse.
  2. The health care provider that the patient sees will follow his or her usual procedures for handling a patient with possible hearing loss. This usually involves checking the ears for wax buildup, further discussion about the possible extent of the loss, and referral to a hearing specialist if warranted.
  3. The Research Nurse will come by the clinics regularly to pick up the contact cards and respond to any questions that medical assistants or other clinic staff may have.
  4. The Research Nurse will then contact potential participants to explain the study, review the consent they took home, ask those still interested in taking part in the study to sign one copy of the consent and place it in the provided envelope for mailing, and administer the baseline questionnaire. She will explain that there will be two follow-up contacts at 4 and 8 months. If participants can hear well enough to do the interviewing over the telephone it will be used for all contact between the Research Nurse and participants. The informed consent will include a self-addressed envelope for mailing the signed copy to the Research Nurse. If participants do not feel they can hear well enough to talk with the Research Nurse over the telephone, all consenting and interviewing will be done at a place of their own choosing.
  5. At the end of the 8-month follow-up, participants from the first two protocol groups will be given the same educational materials (brochure and/or verbal educational protocol) by the study Research Nurse that they would have received had they been in the third protocol group. Thus by the end of the study all participants will have received the brochure and the educational intervention.
Conditions
Hearing Loss
Being tested
Screening, Brochure, Education
Keywords
Hearing loss, Screening, Primary Care
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ScreeningOther

    Standard care screening

  • BrochureOther

    Participants are given an illustrated educational brochure

  • EducationBehavioural

    Participants undergo a in-person educational intervention

Study groups in NCT02037139
Study groupRoleWhat they receive
Control (screening)Active comparatorscreening only (standard care control)
Receives: Other: Screening
Educational brochureActive comparatorScreening + illustrated educational brochure
Receives: Other: Screening; Other: Brochure
EducationExperimentalScreening + illustrated educational brochure + an in-person educational intervention
Receives: Other: Screening; Other: Brochure; Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Referral rates for hearing evaluation

    Proportion of those who screened positive for possible hearing loss who follow through on clinic recommendations for referrals or who elect a referral on their own

    Measured: 8 months after initial screening

Secondary outcomes (1)
  1. Number of changes made to improve hearing

    Other than adopting hearing aids, how many changes did participants make to improve their hearing since screened. Education segment lists 6 possible changes.

    Measured: 8 months after initial screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2014 (estimated)
  2. Study startJul 2013
  3. Primary completion15 Sep 2019
  4. Study completion15 Sep 2019

Resources

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
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02037139
Sponsor's protocol ID
4R33DC011510-03
Status last verified
Nov 2019
First submitted
13 Jan 2014
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Screening, Brochure and Education in people with Hearing Loss, run by University of California, San Francisco 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 6 inclusion and 6 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 13 Nov 2019. 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?

Referral rates for hearing evaluation (time frame: 8 months after initial 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 13 Nov 2019.

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