iManage (my hearing loss) for Hearing Loss

University of Louisville, Program in Audiology, Louisville, KY
Hearing LossiManage (my hearing loss) - Other
Eligibility
45 - 85
All Sexes

Study Summary

This trial will test whether the "I Manage my hearing loss" program can help people who have failed a hearing screening to visit an audiologist.

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline, 4 weeks post baseline, and 6 months post baseline

Month 3
Program completion
Program uptake
Week 4
Mean scores on the Audiology Decision Making Scale, a scale designed to measure preparedness for decision making for 13 specific decision processes
Month 6
Audiologist visit
Week 8
A focus group of individuals who completed the iManage program to learn participants perceptions about the content, benefits and drawbacks of the iManage program
Month 6
Change on the Health Belief Questionnaire, a survey that measures attitudes about the 6 constructs of the Health Belief Model as related to seeking hearing healthcare
Month 6
Change on the Readiness for Change Questionnaire, a single-item questionnaire that attempts to place the participant on a continuum regarding readiness for hearing healthcare as outline by the Transtheoretical Model.
Month 6
Total score on the Hearing Loss Support Scale, a questionnaire that measures self-perceived informational and emotional support from family, peers, and healthcare providers about managing hearing loss.

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Delayed Program Group
1 of 2
Program Group
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: iManage (my hearing loss) · No Placebo Group · N/A

Program Group
Other
Experimental Group · 1 Intervention: iManage (my hearing loss) · Intervention Types: Other
Delayed Program GroupNoIntervention Group · 1 Intervention: Delayed Program Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 weeks post baseline, and 6 months post baseline

Who is running the clinical trial?

University of LouisvilleLead Sponsor
322 Previous Clinical Trials
73,855 Total Patients Enrolled
William Demant Foundation (Formerly known as the Oticon Foundation)UNKNOWN
Jill Preminger, PhDPrincipal InvestigatorProfessor
Laura Galloway, AuDPrincipal InvestigatorProfessor

Eligibility Criteria

Age 45 - 85 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to pass a test that assesses your ability to think and reason.

Frequently Asked Questions

Are individuals still able to participate in this research endeavor?

"Clinicaltrials.gov indicates that this clinical trial, first listed on August 17th 2021, is actively seeking participants. The details of the study were most recently modified on September 3rd 2022." - Anonymous Online Contributor

Unverified Answer

Is eligibility open for enrollment into this research project?

"To qualify, prospective participants must have auditory impairment and be between 45 to 85 years old. Currently, 40 individuals are needed for the medical trial." - Anonymous Online Contributor

Unverified Answer

What is the aggregate number of individuals participating in this research study?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is currently ongoing. First posted on August 17th 2021 and last updated September 3rd 2022, the study seeks 40 participants from 1 research centre." - Anonymous Online Contributor

Unverified Answer

Is there an age restriction for enrollment in this experiment?

"According to the specified entry requirements for this clinical trial, eligible patients must range in age from 45 to 85 years old." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.