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The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids:
Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.
This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTC Hearing Aid First | Other | Participants will be provided a pair of OTC hearing aids (experimental) with typical directions and use for 4 weeks before outcome measures will be assessed. After which, participants will then receive the communication strategies information/counseling (control) and have outcome measures assessed after 4 weeks. |
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| Communication Strategies First | Other | Participants will receive the communication strategies information/counseling intervention (control) first. Outcome measures will be assessed at 4 weeks. After which, participants will then be given a pair of OTC hearing aids (experimental) with typical directions and use for four weeks before having outcome measures assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Over the counter hearing aid | Device | An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT) | A questionnaire completed by the communication partner of the individual with MCI and hearing loss. On this scale, higher scores reflect more frequent and more problematic conversation difficulties; item possible scores range from 0 (not problematic) to 7 (.very problematic) | Baseline at enrollment, then after 4 weeks of using each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing Handicap Inventory for the Elderly (HHIE) | Questionnaire has 25 items with subscales for social and emotional impacts and is scored from 0-100, with 100 representing least handicap. | Baseline at enrollment, then after 4 weeks of using each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Conversation Analysis | The Diapix conversation task where participant and communication partner find the differences in two very similar pictures by discussing them. | 4 weeks after first intervention |
| Adherence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kendra Marks | Contact | 8474670897 | kendra.marks@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pamela Souza, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University HA Lab | Recruiting | Evanston | Illinois | 60201 | United States |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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Those listening and scoring recorded tasks will be blinded to which group the participants are in.
|
|
| Communication Strategies Information/Counseling | Behavioral | Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist. |
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Reported Use (hours per day)
| 4 weeks after each intervention |
| Usability | We will use a modification of the Systematic Usability Scale to query the patient's experience with the OTC aids. | 4 weeks after OTC intervention |
| La Crosse Mayo Clinic | Enrolling by invitation | La Crosse | Wisconsin | 54601 | United States |
| UW Madison | Recruiting | Madison | Wisconsin | 53706 | United States |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D005159 | Health Care Facilities Workforce and Services |