A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes

NCT01940705 | Completed Results

• 3 other identifiers: C1260-R1I01RX001260-013224
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

Hearing loss is the second most prevalent service-connected disability among Veterans. Hearing aids are the most common technological intervention for hearing loss. The VA, therefore, spends a considerable amount of money on them. Despite these expenditures, there are some Veterans who do not use their hearing aids successfully. Research has demonstrated that this inconsistent use may be related to a patient's inability to effectively take care of, and use, hearing aids. The proposed investigation will compare the effectiveness of three different tools for enhancing the educational efforts (hearing-aid orientation) typically provided by clinical audiologists when dispensing hearing aids. Each of these educational tools were developed using established methods for improving patient-provider communication. The investigators hypothesize that the use of these tools will result in better hearing-aid outcomes for Veteran patients than using the current standard-of-care procedures.

Conditions

Hearing Loss

Keywords

hearing aids; counseling; outcomes assessment (health care); rehabilitation

Outcome Measures

Primary Outcomes (1)

• Hearing Aid Skills and Knowledge Test

  Hearing Aid Skills and Knowledge measures knowledge and skills for tasks associated with hearing aid management, such as knowledge of and ability to change batteries, insert the hearing aid, etc. For knowledge scale, participant gives a verbal response. Items are assigned points: 0 (incorrect response) or 1 (correct response). For skills scale, participant conducts the required task. Items are assigned points: 0 (Could not perform task), 1 (Achieved with some difficulty, more than one attempt) or 2 (Achieved with no difficulty on first attempt). There were 15 knowledge items and 19 skill items. Percent correct was computed for each scale separately. Points were totaled, divided by the no. items with valid data, and multiplied by 100, with a correction to equate subscales. For the skills scale, percent correct scores were calculated based upon the notion that a value of 2 was considered 100% correct, 1 was considered 50% correct.

  4 weeks after the hearing-aid fitting

Secondary Outcomes (2)

• The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids

  4 weeks after the hearing-aid fitting

• International Outcome Inventory for Hearing Aids.

  4 weeks after the hearing-aid fitting

Study Arms (4)

Standard of care (SoC)

ACTIVE COMPARATOR

standard of care hearing-aid orientation as provided by clinical audiologist

Other: Standard of Care

SoC plus hearing-aid informational guide

EXPERIMENTAL

standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids

Other: Hearing-Aid Informational Guide; Other: Standard of Care

SoC plus hearing aid DVD

EXPERIMENTAL

SoC hearing-aid orientation as provided by clinical audiologist plus a take-home hearing aid digital video disc

Other: Hearing-Aid DVD; Other: Standard of Care

Soc plus teach-back technique

EXPERIMENTAL

standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique session reviewing information on the hearing aids

Behavioral: Teach-back Technique; Other: Standard of Care

Interventions

Hearing-Aid Informational Guide OTHER

Printed take-home guide on hearing aids

SoC plus hearing-aid informational guide

Hearing-Aid DVD OTHER

Take-home DVD about hearing aids

SoC plus hearing aid DVD

Teach-back Technique BEHAVIORAL

Counseling/Educational session using the teach-back technique to review information about their hearing aids

Soc plus teach-back technique

Standard of Care OTHER

standard of care hearing-aid orientation as provided by clinical audiologist

SoC plus hearing aid DVD; SoC plus hearing-aid informational guide; Soc plus teach-back technique; Standard of care (SoC)

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be Veterans who are receiving hearing aids from the Audiology Clinic at the VA Portland Health Care System and who have had no prior experience using hearing aids. To be included in the study, participants will:
• Be approved and have plans to get bilateral hearing aid fitting at the VA Portland Health Care System .
• Be able to read and converse in English.

You may not qualify if:

• Be younger than 50 years or older than 89 years of age.
• Have a documented diagnosis of neurological, cognitive, visual, or other mental disorder, such as Alzheimer's disease, schizophrenia, current alcohol or substance abuse, as determined by chart review that would interfere with study completion.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Gabrielle Saunders, PhD
• Organization: VA RR&D National Center for Rehabilitative Auditory Research

Gabrielle.Saunders@va.gov

503-220-8262

Study Officials

• M. Samantha Lewis, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

• Gabrielle H Saunders

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: January 1, 2014
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: February 21, 2019
• Results First Posted: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)