Hearing Loss Clinical Trial
Official title:
Addressing Barriers to Adult Hearing Healthcare
Verified date | November 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this project is to develop evidence that can inform hearing health care best practices for adults between the ages of 65-75, and determine what level of involvement by the primary care practitioner (PCP) is required to inform and encourage adults age 65-75 to follow through with routine hearing screening. This study also aims to evaluate the accuracy of assessment of medical conditions for which the FDA requires physician evaluation and management prior to hearing aid fitting, and determine which medical conditions should require medical evaluation prior to hearing aid fitting. The results of this study should provide information to implement changes in health care policy to facilitate accessible and affordable hearing health care.
Status | Completed |
Enrollment | 1146 |
Est. completion date | August 27, 2021 |
Est. primary completion date | August 27, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 75 Years |
Eligibility | Primary Care Cohort: Inclusion Criteria: - 65-75 years of age - Being seen by PCP for non-acute follow-up or annual appointment for primary care - No prior history of hearing aid use or self-reported diagnosis of hearing loss Exclusion Criteria: - Not between the ages of 65-75 - Current or past hearing aid user - Patient has been tested by an audiologist in the past and self-reports a hearing loss diagnosis - Being seen by the PCP for an acute illness CHEER Cohort: Inclusion Criteria: - 65-75 years of age - Being seen by an OHNS/ENT provider for a complaint of hearing loss. - Is scheduled to have an audiogram as standard of care for complaint of hearing loss. - No prior diagnosis of hearing loss by a medical professional or history of hearing aid use Exclusion Criteria: - Not between the ages of 65-75 - Current or past hearing aid user - Prior diagnosis of hearing loss or hearing aid user |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Central Oregon ENT | Bend | Oregon |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Northwell Health | New Hyde Park | New York |
United States | New York Eye and Ear of Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Significance of medical conditions requiring medical evaluation prior to hearing aid fitting | Analysis to determine what medical conditions should require medical evaluation prior to hearing aid fitting (CHEER Cohort) | 1 day, completion of patient, audiologist and provider questionnaires | |
Other | Cost to conduct telephone hearing screening in the Primary Care clinic setting | Cost to conduct hearing screening based on costs of educational material, telephone screening test, provider time and clinic space. (Both Cohorts) | 1 day | |
Other | Attitudes towards hearing loss | Analysis of attitudes towards hearing loss using the ALHQ questionnaire and focus group discussions | 2 days | |
Other | Attitudes of communication partners regarding hearing loss | Evaluation of how attitudes of significant others impact decision making to pursue hearing screening, diagnostic testing, and intervention. | 1 day, completion of the Significant Other Hearing Questionnaire (SOS-HEAR) | |
Primary | Completion of Tele-HS screen | The proportion (%) of subjects in Groups 1 and 2 who take the test will be compared to those in Group 3. | 2 months of PCP appointment (day 1) | |
Primary | Medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting | Analysis of medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting by comparing red flag assessments from patient, audiologist and ENT provider (CHEER Cohort) | 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider) | |
Secondary | Scheduling of follow-up audiological testing | The proportion (%) of subjects in Groups 1 and 2 who fail the Tele-HS and schedule follow-up testing compared to those in Group 3. | 4 months of date of Tele-HS | |
Secondary | Completion of follow-up audiological testing | The proportion (%) of subjects in Groups 1 and 2 who fail the Tele-HS and complete follow-up testing compared to those in Group 3. | 4 months of date of Tele-HS | |
Secondary | Completion of plan for appropriate hearing loss intervention, if applicable | The proportion (%) of subjects in Groups 1 and 2 who fail the Tele-HS, complete follow-up testing, and complete a plan for hearing loss intervention, if applicable, compared to those in Group 3. | 4 months of date of Tele-HS |
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