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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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..
- Examine hearing health outcomes by patient and clinic characteristics.
- 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:
- 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.
- Training for the finger rub and what to do during the three protocols will be conducted by the study's Research Nurse.
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Control (screening) | Active comparator | screening only (standard care control) Receives: Other: Screening |
| Educational brochure | Active comparator | Screening + illustrated educational brochure Receives: Other: Screening; Other: Brochure |
| Education | Experimental | Screening + 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.
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)
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.
- First posted15 Jan 2014 (estimated)
- Study startJul 2013
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
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 California, San FranciscoThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret I Wallhagen, Principal investigator, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Intervention Promoting Hearing Health Care Service Access and Use
- ClinicalTrials.gov ID
- NCT02037139
- Acronym / sponsor ID
- 4R33DC011510-03
- Conditions
- Hearing Loss
- Keywords
- Hearing loss, Screening, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 15 Jan 2014 (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.
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.
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:
- 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..
- Examine hearing health outcomes by patient and clinic characteristics.
- 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:
- 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.
- Training for the finger rub and what to do during the three protocols will be conducted by the study's Research Nurse.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (screening) | Active comparator | Other: Screeningscreening only (standard care control) |
| Educational brochure | Active comparator | Other: Screening, Other: BrochureScreening + illustrated educational brochure |
| Education | Experimental | Other: Screening, Other: Brochure, Behavioral: EducationScreening + illustrated educational brochure + an in-person educational intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| ScreeningStandard care screening | Other | Control (screening), Education, Educational brochure |
| BrochureParticipants are given an illustrated educational brochure | Other | Education, Educational brochure |
| EducationParticipants undergo a in-person educational intervention | Behavioural | Education |
Primary outcome
Referral rates for hearing evaluation
Time frame: 8 months after initial screening
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
1 secondary outcome
Number of changes made to improve hearing
Time frame: 8 months after initial screening
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 13 Nov 2019.
- 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.
Margaret I Wallhagen principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.