HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorJohns Hopkins University
About this trial
This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 60 years or older
English-speaking
Aural-oral verbal communication as primary communication modality
Post-lingual hearing loss (Audiometric pure tone averages [0.5-2kHz] in better ear >25 dB)
Disqualifiers
Current self-reported use of hearing aid or amplification device
Medical contraindication to use hearing aids (e.g. draining ears)
Trial design
Design model
Single group
Treatments tested in this trial
HEARS MD Device
DeviceTailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component.
HEARS MD Program
BehavioralTailored aural rehabilitation for participant.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Immediate treatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Intervention feasibility (enrollment rate)
Percentage of eligible individuals who enroll in the trial
Time frame
Baseline, 1-week, 3-months, and 6-months post-intervention2
Intervention feasibility (intervention retention)
Percentage of participants who complete the Hearing Handicap Inventory for the Elderly (HHIE-S)
Time frame
Baseline, 1-week, 3-months, and 6-months post-interventionSecondary outcomes
1
Change in Hearing Handicap Inventory for the Elderly (HHIE-S)
Scoring: 0-8 suggests no hearing handicap; 10-24 suggests mild-moderate hearing handicap; 26-40 suggests significant hearing handicap. Score range 0-40, an increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Time frame
Baseline, 1-week, 3-months, and 6-months post-intervention2
International Outcome Inventory for Hearing Aids (IOI-HA)
The hearing inventory survey is used to evaluate the effectiveness of alternative interventions such as assistive devices and communication strategies. The total score ranges from 7-35, where higher scores indicate a better outcome.
Time frame
Baseline, 1-week, 3-months, and 6-months post-interventionLocations
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: