Back to resultsHearing Aid Education and Adaptation System
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TELLYHealth
Sponsored by
About this trial
This is an interventional health services research trial for Hearing Loss focused on measuring Hearing loss, Presbycusis, Aging, Teleaudiology
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Lives with person who has enrolled in the study
Sites / Locations
- Clear Sound Audiology
- Potomac Audiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TELLYHealth Group
Standard of Care Group
Arm Description
Subjects 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.
Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.
Outcomes
Primary Outcome Measures
Hearing Handicap Inventory for the Elderly (HHIE)
Pre-post changes in the HHIE total scores
Secondary Outcome Measures
Communication Scale for Older Adults (CSOA)
Pre-post changes in the CSOA communication strategies & attitudes scores
Full Information
NCT ID
NCT02839759
First Posted
July 15, 2016
Last Updated
May 12, 2020
Sponsor
Healthcare Technologies and Methods, LLC
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02839759
Brief Title
Hearing Aid Education and Adaptation System
Official Title
Interactive Technology for Hearing Aid Education and Acceptance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthcare Technologies and Methods, LLC
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
HTM will develop the "TELLYHealth (tm) system" that will provide education on hearing aid use and maintenance. HTM will conduct a randomized controlled trial (RCT) to quantify the benefits of TELLYHealth to patients and audiologists including: reductions in hearing handicap, improved knowledge of hearing aid handling, use and communications strategies; and improved audiologist aftercare. The investigators will recruit 80 subjects (half in each group) and each subject will participate in the study for 8-12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing loss, Presbycusis, Aging, Teleaudiology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TELLYHealth Group
Arm Type
Experimental
Arm Description
Subjects 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.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.
Intervention Type
Other
Intervention Name(s)
TELLYHealth
Intervention Description
Educational videos and questions.
Primary Outcome Measure Information:
Title
Hearing Handicap Inventory for the Elderly (HHIE)
Description
Pre-post changes in the HHIE total scores
Time Frame
8-12 weeks
Secondary Outcome Measure Information:
Title
Communication Scale for Older Adults (CSOA)
Description
Pre-post changes in the CSOA communication strategies & attitudes scores
Time Frame
8-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Lives with person who has enrolled in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan M Letzt, M.S.
Organizational Affiliation
Healthcare Technologies and Methods, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clear Sound Audiology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Potomac Audiology
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Aggregated data on hearing aid education will be shared.
IPD Sharing Time Frame
The date will be available approximately May 2025 for one year.
IPD Sharing Access Criteria
The criteria will be based on the policies of the selected data repository.
Learn more about this trial
Hearing Aid Education and Adaptation System
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