Hearing Aid Education and Adaptation System

Sponsor

Healthcare Technologies and Methods, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02839759

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Other: TELLYHealth	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Interactive Technology for Hearing Aid Education and Acceptance

Actual Study Start Date :

Aug 31, 2018

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TELLYHealth Group 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.	Other: TELLYHealth Educational videos and questions.
No Intervention: Standard of Care Group Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.

Arm

Intervention/Treatment

Experimental: TELLYHealth Group

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.

Other: TELLYHealth

Educational videos and questions.

No Intervention: Standard of Care Group

Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.

Outcome Measures

Primary Outcome Measures

Hearing Handicap Inventory for the Elderly (HHIE) [8-12 weeks]
Pre-post changes in the HHIE total scores

Secondary Outcome Measures

Communication Scale for Older Adults (CSOA) [8-12 weeks]
Pre-post changes in the CSOA communication strategies & attitudes scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clear Sound Audiology	Gainesville	Florida	United States	32605
2	Potomac Audiology	Rockville	Maryland	United States	20852

Sponsors and Collaborators

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

Investigators

Principal Investigator: Alan M Letzt, M.S., Healthcare Technologies and Methods, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Healthcare Technologies and Methods, LLC

ClinicalTrials.gov Identifier:

NCT02839759

Other Study ID Numbers:

HTM092016
R44AG045947

First Posted:

Jul 21, 2016

Last Update Posted:

May 14, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Healthcare Technologies and Methods, LLC

Additional relevant MeSH terms:

Hearing Loss

Deafness

Study Results

No Results Posted as of May 14, 2020