Hearing LossNCT03864003
Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
A study testing Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care 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 feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care. 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 Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 4 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
- Bilateral hearing loss within the fitting range of study hearing aids
Who cannot join
- Medically unqualified to receive hearing aids
- Current hearing aid user
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Mariposa Community Health Center
Nogales, Arizona, 85621
About this study
The purpose of this study is to test the feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care.
- Conditions
- Hearing Loss
- Being tested
- Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health 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.
Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health CareBehavioural
In this project, remote hearing aid fittings will be delivered by an audiologist with patient-site support from a local facilitator for a cohort of older adults (>50 years) from a rural area that has been identified as under-resourced for hearing health care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants randomized to the experimental group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a Community Health Worker. Receives: Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care |
| Control Group | Active comparator | Participants randomized to the control group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a non-Community Health Worker (undergraduate student in Speech, Language, and Hearing Sciences). Receives: Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire
The Self-Efficacy for Situational Communication Management Questionnaire (Jennings, 2005; Jennings et al, 2014) measures self-perceived hearing ability and hearing self-efficacy, or a participant's beliefs in their ability to manage communication with acquired hearing loss. The SESMQ contains 20 situations that are rated on two scales, hearing ability and perceived self-efficacy. Participants respond on a Likert scale from 0 (not well at all) to 10 (very well) to how well they can hear and how well they can manage in each situation. Total scores on each scale range from 0-200, with higher scores representing better perceived self-efficacy and better hearing ability. The two scales are scored and reported separately.
We will evaluate the differences in SESMQ scores between experimental and control groups at 2-weeks post hearing aid fitting. Analyses will utilize baseline data and follow-up analyses will occur for 6-week and 12-week timepoints.
Measured: Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting
Secondary outcomes (5)
Hearing aid benefit
The Effectiveness of Auditory Rehabilitation (Yueh et al., 2005; EAR) is a subjective scale of hearing aid function and quality of life. The first set of questions is administered before and after the hearing aid fitting, and relates to hearing concerns, including listening in quiet and other situations. The second set of questions relates to functioning with the hearing device, such as fit and convenience, and is administered after the hearing aid fitting.
We will evaluate the differences in inner EAR scores between experimental and control groups at 6-weeks post hearing aid fitting. Analyses will utilize baseline data where appropriate and follow-up analyses will occur for 6-week and 12-week timepoints.
Participants are asked to respond to statements on a five-point scale (i.e. very poor, poor, so-so, good, very good). Each answer is awarded a point. Higher cumulative scores indicate better benefit.
Measured: Baseline, 6 weeks, and 14 weeks after hearing aid fitting
Satisfaction with teleaudiology service delivery
Telehealth Satisfaction Scale (TeSS)
The TeSS is a 10-item scale probing satisfaction with telehealth services. Responses are on a 4-point likert scale (Excellent, good, poor, fair). Higher cumulative scores represent better satisfaction.
Measured: 2 weeks after hearing aid fitting
Qualitative outcomes via semi-structured interviews
Qualitative outcomes will target participants' subjective experience on access to hearing health care, self-efficacy, benefit, and satisfaction with service delivery and hearing aids.
Measured: 14 weeks after hearing aid fitting
Average hours of hearing aid usage per day
We will ask participants the approximate average hours per day they use their hearing aid. This information will also be collected from the hearing aid programming software.
Measured: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting
Subjective hearing aid benefit
Subjective hearing aid benefit will also be measured using a patient reported outcome measure, the International Outcome Inventory for Hearing Aids (IOI-HA). Participants are asked to respond to seven questions on their experience with their hearing aids. Questions on the IOI-HA are on a 5-point Likert-type scale. Cumulative scores range from zero to 35. Higher scores represent better benefit.
Measured: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start30 Oct 2019
- Primary completion27 Mar 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Coco, University of Arizona
- Investigators
- Laura S Coco, AuD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864003
- Sponsor's protocol ID
- 1F32DC017081
- Status last verified
- May 2022
- First submitted
- 3 Mar 2019
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coco L, Leon K, Navarro C, Piper R, Carvajal S, Marrone N. "Close to My Community": A Qualitative Study of Community Health Worker-Supported Teleaudiology Hearing Aid Services. Ear Hear. 2024 Sep-Oct 01;45(5):1191-1201. doi: 10.1097/AUD.0000000000001507. Epub 2024 May 30.
PubMed 38812073Marrone 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
- ClinicalTrials.gov ID
- NCT03864003
- Acronym / sponsor ID
- 1F32DC017081
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 6 Mar 2019 (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 feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health CareParticipants randomized to the experimental group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a Community Health Worker. |
| Control Group | Active comparator | Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health CareParticipants randomized to the control group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a non-Community Health Worker (undergraduate student in Speech, Language, and Hearing Sciences). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bilateral hearing loss within the fitting range of study hearing aids
Key exclusion criteria (3 listed)
- Medically unqualified to receive hearing aids
- Current hearing aid user
- Cognitively impaired
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 Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health CareIn this project, remote hearing aid fittings will be delivered by an audiologist with patient-site support from a local facilitator for a cohort of older adults (>50 years) from a rural area that has been identified as under-resourced for hearing health care. | Behavioural | Control Group, Experimental group |
Primary outcome
Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire
Time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting
The Self-Efficacy for Situational Communication Management Questionnaire (Jennings, 2005; Jennings et al, 2014) measures self-perceived hearing ability and hearing self-efficacy, or a participant's beliefs in their ability to manage communication with acquired hearing loss. The SESMQ contains 20 situations that are rated on two scales, hearing ability and perceived self-efficacy. Participants respond on a Likert scale from 0 (not well at all) to 10 (very well) to how well they can hear and how well they can manage in each situation. Total scores on each scale range from 0-200, with higher scores representing better perceived self-efficacy and better hearing ability. The two scales are scored and reported separately. We will evaluate the differences in SESMQ scores between experimental and control groups at 2-weeks post hearing aid fitting. Analyses will utilize baseline data and follow-up analyses will occur for 6-week and 12-week timepoints.
5 secondary outcomes
Hearing aid benefit
Time frame: Baseline, 6 weeks, and 14 weeks after hearing aid fitting
Satisfaction with teleaudiology service delivery
Time frame: 2 weeks after hearing aid fitting
Qualitative outcomes via semi-structured interviews
Time frame: 14 weeks after hearing aid fitting
Average hours of hearing aid usage per day
Time frame: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting
Subjective hearing aid benefit
Time frame: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting
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 17 May 2022.
- Derived from this study: PubMed 38812073Coco L, Leon K, Navarro C, Piper R, Carvajal S, Marrone N. "Close to My Community": A Qualitative Study of Community Health Worker-Supported Teleaudiology Hearing Aid Services. Ear Hear. 2024 Sep-Oct 01;45(5):1191-1201. doi: 10.1097/AUD.0000000000001507. Epub 2024 May 30.
- 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
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
Laura S Coco, AuD 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 Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care 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 1 inclusion and 3 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 17 May 2022. 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?
Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire (time frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting). 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 NCT03864003, which also lists 2 linked publications.
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 17 May 2022.