Overview

This trial is active, not recruiting.

Condition hearing loss
Treatments hearing-aid informational guide, hearing-aid dvd, teach-back technique, standard of care
Sponsor VA Office of Research and Development
Start date January 2014
End date September 2016
Trial size 468 participants
Trial identifier NCT01940705, 1I01RX001260-01, 3224, C1260-R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
standard of care hearing-aid orientation as provided by clinical audiologist
standard of care
standard of care hearing-aid orientation as provided by clinical audiologist
(Experimental)
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
hearing-aid informational guide
Printed take-home guide on hearing aids
standard of care
standard of care hearing-aid orientation as provided by clinical audiologist
(Experimental)
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
hearing-aid dvd
Take-home DVD about hearing aids
standard of care
standard of care hearing-aid orientation as provided by clinical audiologist
(Experimental)
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
teach-back technique
Counseling/Educational session using the teach-back technique to review information about their hearing aids
standard of care
standard of care hearing-aid orientation as provided by clinical audiologist

Primary Outcomes

Measure
Practical hearing aid skills and information knowledge/recall test
time frame: 4 weeks after the hearing-aid fitting

Secondary Outcomes

Measure
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids
time frame: 4 weeks after the hearing-aid fitting
International Outcome Inventory for Hearing Aids
time frame: 4 weeks after the hearing-aid fitting
Practical hearing aid skills and information knowledge/recall test
time frame: 6 months after the hearing-aid fitting
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids
time frame: 6 months after the hearing-aid fitting
International Outcome Inventory for Hearing Aids
time frame: 6 months after the hearing-aid fitting

Eligibility Criteria

Male or female participants from 50 years up to 89 years old.

Inclusion Criteria: 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. Exclusion Criteria: - 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, etcetera, as determined by chart review that would interfere with study completion.

Additional Information

Official title A Simplified Patient Centered Educational Tool for Improved Hearing Aid Outcomes
Principal investigator M. Samantha Lewis, PhD
Description Objectives: Reasons for non-use of hearing aids are varied, but many studies have suggested that a lack of knowledge about how to use and/or take care of the hearing aids is a major factor. This is not surprising given that other healthcare fields have reported that between 40-80% of information provided during a clinical appointment is forgotten by the patient immediately after the appointment and almost half of what is remembered is not correct. The long-term goal of this project is to improve the delivery of information during the hearing-aid orientation, as better delivery of information will result in better hearing-aid handling skills and thus better overall hearing-aid outcomes. To accomplish this goal, the investigators propose to refine and evaluate the effectiveness of three forms of supplemental hearing-aid-orientation tools, each of which was developed using established guidelines for good patient-provider communication. Plan: The purpose of the proposed application is to evaluate the relative effectiveness of four forms of hearing-aid orientation provided to first time hearing-aid users, three of which use some of the aforementioned strategies to enhance the standard of care. The four forms of orientation will be: (1) the standard-of-care hearing-aid orientation; (2) the standard of care plus provision a hearing-aid information guide (HAIG) (3) the standard of care supplemented by an explanation of its content using the talk-back technique to confirm patient understanding; and (4) the standard of care plus provision of a take-home hearing-aid orientation DVD (HAO DVD). The content of the HAIG will be field tested and finalized following input obtained via focus groups with clinical audiologists and first-time hearing aid users. Methods: For the field testing up to 16 clinical audiologists and 10 new hearing aid user Veterans will be recruited to participate in focus groups during which they will view and then be asked questions about the content of the HAIG. Information learned during these focus groups will then be incorporated into the HAIG, at which time they will be ready for use in the study. For the comparative effectiveness study, up to 468 hearing-impaired Veterans who are about to become first-time hearing-aid users will be enrolled to participate in this investigation. These individuals will be recruited from the VA Portland Health Care System's Audiology and Speech Pathology Service (ASPS). Prior to receiving their hearing aids, subjects will be enrolled in the study at the National Center for Rehabilitative Auditory Research (NCRAR), and will conduct health literacy, manual dexterity and hepatic sensitivity, visual acuity, and learning and memory assessments. They will then attend their hearing aid fitting in the ASPS and will receive standard-of-care hearing-aid orientation. At the end of that appointment, they will receive one of the four study interventions. Subjects will return to the NCRAR 4-6 weeks after the hearing-aid-fitting appointment to complete the following outcome measures: a knowledge and practical test regarding hearing-aid use and care, a measure of self-efficacy, and a measure of hearing-aid outcomes. They also will be interviewed so that the investigators can learn their opinions about the intervention. A subset of the initial 50 participants enrolled into each study arm will attend a second follow-up appointment 6 months after the fitting appointment so the investigators can examine longer-term impacts of the hearing aid orientation interventions.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.