Hearing Aid Education and Adaptation System
Interactive Technology for Hearing Aid Education and Acceptance
2 other identifiers
interventional
52
1 country
2
Brief Summary
This RCT will have two arms: A control group that receives the standard of care from audiologists and an experimental group that receives both the standard of care and the at-home use of the TELLYHealth intervention. Subjects in each group will complete questionnaires at enrollment, mid-study and at the end of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedStudy Start
First participant enrolled
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMay 14, 2020
May 1, 2020
1.7 years
July 15, 2016
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hearing Handicap Inventory for the Elderly (HHIE)
Pre-post changes in the HHIE total scores
8-12 weeks
Secondary Outcomes (1)
Communication Scale for Older Adults (CSOA)
8-12 weeks
Study Arms (2)
TELLYHealth Group
EXPERIMENTALSubjects will receive the standard of care in hearing aid education and the TELLYHealth intervention for use over an 8 to12-week period and will be followed by their audiologist for 8 to 12 weeks.
Standard of Care Group
NO INTERVENTIONSubjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Speaks and reads English fluently
- Has mild (25-40 dB) to severe (70-95 dB) monaural sensorineural hearing loss
- Will be fitted with one or two hearing aids at the time of enrollment
- Owns a standard TV
- Has Internet access at home
- Has sufficient corrected vision to watch videos and read text on the TV and mobile device
- No signs of dementia
You may not qualify if:
- Lives with person who has enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clear Sound Audiology
Gainesville, Florida, 32605, United States
Potomac Audiology
Rockville, Maryland, 20852, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan M Letzt, M.S.
Healthcare Technologies and Methods, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2016
First Posted
July 21, 2016
Study Start
August 31, 2018
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
May 14, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- The date will be available approximately May 2025 for one year.
- Access Criteria
- The criteria will be based on the policies of the selected data repository.
Aggregated data on hearing aid education will be shared.