A System and Process to Improve the Satisfaction With Hearing Health Products

Hearing Loss Clinical Trial

Official title:

A System and Process to Improve the Satisfaction With Hearing Health Products

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926636
• Other study ID #: STUDY00010555
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: Peggy Nelson, PhD, CCC-A
• Phone: 612-625-4569
• Email: peggynelson[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process.

Description:

As of 2015, 28.8 million U.S. adults could benefit from using hearing aids and the prevalence of hearing loss in the United States is predicted to rise significantly due to an aging population and the growing use of personal listening devices. However, only 28.5% of individuals who could benefit from a HA actually wears one. The non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. As the market moves towards a, direct-to-consumer distribution model following the 2017 FDA directive, more patients will be receiving therapy for hearing loss. While in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. Hypothesis: The investigators hypothesize that the integration of Health and Wellness Coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. Specific Aims: 1) Create patient/coach interaction protocol and training; 2) Develop a cloud-based Health Coaching Interface; 3) Evaluate system effectiveness through a clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• Significantly reduced cognitive ability (assessed using the Montreal Cognitive Assessment MoCA)

• Lack of proficiency communicating in English

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Behavioral:
• Health and Wellness Coaching
An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COSI Goal Achievement	The Client Oriented Scale of Improvement (COSI) questionnaire tracks the goals and needs of the patient through their hearing aid fitting process. Items allow the patient to qualify their degree of change for each of their needs/goals as 1) Much Worse 2) Worse 3) No Difference 4) Better 5) Much Better. Total scores are an average of item scores and range from 1 to 5 with higher scores indicating more improvement.	3 months
Primary	AQoL-8D Score	The Assessment of Quality of Life (AQoL) is a measure of health-related Quality of Life. AQoL-8D covers dimensions of Independent Living, Happiness, Mental Health, Coping, Relationships, Self-Worth, Pain, and Senses. Items are scored from 0 to 3. Scores range from 0 to 45 with higher scores indicating poorer quality of life.	3 months
Secondary	Hours of Hearing Aid Use	Hearing aid usage information for both groups will be automatically logged on non-volatile memory inside of the hearing aid. It will record the amount of time in hours the user spent wearing their hearing aids. It is accessed and downloaded through the provided companion smartphone application.	3 months