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

University of Minnesota (UMN)

Status: Completed

Conditions: Hearing Loss

Treatments: Behavioral: Health and Wellness Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04926636

STUDY00010555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria

• Significantly reduced cognitive ability (assessed using the Montreal Cognitive Assessment MoCA)
• Lack of proficiency communicating in English

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Standard Mobile App

No Intervention group

Description:

This group will be supplied with Novidan DTC hearing aids and documentation following standard of care as a control. They will be provided with the mobile application allowing for the monitoring of data for study analysis and personal control of their hearing aids, but not Health and Wellness Coaching features.

Enhanced Mobile App with Health Coaching

Experimental group

Description:

This group will also be supplied with the Novidan DTC hearings aids and documentation, same as the control group, but will be supplied the enhanced mobile application that allows for participation in health coaching features. They will be assigned to a health coach and will have coaching sessions scheduled.

Treatment:

Behavioral: Health and Wellness Coaching