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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02839759
Other study ID # HTM092016
Secondary ID R44AG045947
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2018
Est. completion date April 30, 2020

Study information

Verified date May 2020
Source Healthcare Technologies and Methods, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TELLYHealth
Educational videos and questions.

Locations

Country Name City State
United States Clear Sound Audiology Gainesville Florida
United States Potomac Audiology Rockville Maryland

Sponsors (2)

Lead Sponsor Collaborator
Healthcare Technologies and Methods, LLC National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hearing Handicap Inventory for the Elderly (HHIE) Pre-post changes in the HHIE total scores 8-12 weeks
Secondary Communication Scale for Older Adults (CSOA) Pre-post changes in the CSOA communication strategies & attitudes scores 8-12 weeks
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