Hearing LossNCT03255161
Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)
A study testing community health worker-audiologist communication education and support group in people with Hearing Loss, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- community health worker-audiologist communication education and support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2015to 1 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age: 50 years
- Audiometrically-confirmed hearing loss
- Availability of a communication partner to attend the program with the participant
- Be Spanish speaking and able to sign written informed consent
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mariposa Community Health Center
Nogales, Arizona, 85621-1063
About this study
Official title: Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border
The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.
- Conditions
- Hearing Loss
- Being tested
- community health worker-audiologist communication education and support group
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community health worker-audiologist communication education and support groupBehavioural
A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.
| Study group | Role | What they receive |
|---|---|---|
| Immediate communication education and support group | Experimental | Not described Receives: Behavioral: community health worker-audiologist communication education and support group |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention
Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly.
Measured: 8 weeks
Secondary outcomes (1)
Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
Questionnaire includes 7 possible actions for managing hearing health or accessing hearing health care services (discussed with family, discussed with doctor, discussed with specialist, had a hearing test, used an assistive device, used a hearing aid, used hearing protection).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start19 Aug 2015
- Primary completion23 Jan 2019
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Nicole Marrone, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255161
- Sponsor's protocol ID
- UArizona1
- Other IDs
- R33DC013681
- Status last verified
- Oct 2018
- First submitted
- 14 Aug 2017
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
PubMed 35724253
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border
- ClinicalTrials.gov ID
- NCT03255161
- Acronym / sponsor ID
- UArizona1
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 21 Aug 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 purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate communication education and support group | Experimental | Behavioral: community health worker-audiologist communication education and support group |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum age: 50 years
- Audiometrically-confirmed hearing loss
- Availability of a communication partner to attend the program with the participant
- Be Spanish speaking and able to sign written informed consent
Key exclusion criteria (1 listed)
- Cognitive impairment
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 |
|---|---|---|
| community health worker-audiologist communication education and support groupA 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist. | Behavioural | Immediate communication education and support group |
Primary outcome
Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention
Time frame: 8 weeks
Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly.
1 secondary outcome
Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Derived from this study: PubMed 35724253Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
- 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.
Nicole Marrone, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community health worker-audiologist communication education and support group in people with Hearing Loss, run by University of Arizona 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 4 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: status not confirmed, as of the sponsor's last update on 7 Oct 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?
Results are not available in the source record.
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?
Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255161, which also lists 1 linked publication.
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 7 Oct 2019.