Hearing Aid Education and Adaptation System | NCT02839759

Studies
Hearing Aid Education and Adaptation System

NCT02839759

Sponsor

Healthcare Technologies and Methods, LLC

Status

Completed

Last Update Posted

May 14, 2020Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

TELLYHealth

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R44AG045947	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2018Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2020

Last Update Posted Date

May 14, 2020Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TELLYHealth Group	Experimental	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
Standard of Care Group	No Intervention	Subjects will receive the standard of care in hearing aid education and will be followed by their audiologist for 8 to 12 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TELLYHealth	Other	Educational videos and questions.	TELLYHealth Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hearing Handicap Inventory for the Elderly (HHIE)	Pre-post changes in the HHIE total scores	8-12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Communication Scale for Older Adults (CSOA)	Pre-post changes in the CSOA communication strategies & attitudes scores	8-12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan M Letzt, M.S.	Healthcare Technologies and Methods, LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clear Sound Audiology		Gainesville	Florida	32605	United States
Potomac Audiology

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Aggregated data on hearing aid education will be shared.

Types

Study Protocol
Clinical Study Report (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss
D011304	Presbycusis

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided