Hearing LossNCT01940705
A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes
A study testing Hearing-Aid Informational Guide, Hearing-Aid DVD and Teach-back Technique in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing-Aid Informational Guide, Hearing-Aid DVD and Teach-back Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2014to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: A Simplified Patient Centered Educational Tool for Improved Hearing Aid Outcomes
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.
Read the detailed 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.
- Conditions
- Hearing Loss
- Being tested
- Hearing-Aid Informational Guide, Hearing-Aid DVD, Teach-back Technique, Standard of Care
- Keywords
- hearing aids, counseling, outcomes assessment (health care), rehabilitation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing-Aid Informational GuideOther
Printed take-home guide on hearing aids
Hearing-Aid DVDOther
Take-home DVD about hearing aids
Teach-back TechniqueBehavioural
Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of CareOther
standard of care hearing-aid orientation as provided by clinical audiologist
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (SoC) | Active comparator | standard of care hearing-aid orientation as provided by clinical audiologist Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Teach-back Technique; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after the hearing-aid fitting
Secondary outcomes (2)
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids
12-item questionnaire assessing self-efficacy for basic and advanced hearing aid handling skills. Item responses are on a scale of 0 to 100 in 10 point increments. Score of 0 = no self efficacy to100 = complete self efficacy. Final score is an average of individual item responses.
Measured: 4 weeks after the hearing-aid fitting
International Outcome Inventory for Hearing Aids.
Hearing-aid outcomes questionnaire assessing benefit, satisfaction, use, etc. Seven items, each on a scale of 1-5. 1 = low satisfaction/benefit/use etc., 5 = maximum satisfaction/benefit/use etc. A total score is derived by summing the score from each of the seven items. Total scores range from a low of 7 to a high of 35.
Measured: 4 weeks after the hearing-aid fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study start1 Jan 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- M. Samantha Lewis, PhD, Principal investigator, VA Portland Health Care System, Portland, ORGabrielle H Saunders, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940705
- Sponsor's protocol ID
- C1260-R
- Other IDs
- 1I01RX001260-01, 3224
- Status last verified
- Feb 2019
- First submitted
- 9 Sep 2013
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simplified Patient Centered Educational Tool for Improved Hearing Aid Outcomes
- ClinicalTrials.gov ID
- NCT01940705
- Acronym / sponsor ID
- C1260-R
- Conditions
- Hearing Loss
- Keywords
- hearing aids, counseling, outcomes assessment (health care), rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Posted 21 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of care (SoC) | Active comparator | Other: Standard of Carestandard of care hearing-aid orientation as provided by clinical audiologist |
| SoC plus hearing-aid informational guide | Experimental | Other: Hearing-Aid Informational Guide, Other: Standard of Carestandard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids |
| SoC plus hearing aid DVD | Experimental | Other: Hearing-Aid DVD, Other: Standard of CareSoC hearing-aid orientation as provided by clinical audiologist plus a take-home hearing aid digital video disc |
| Soc plus teach-back technique | Experimental | Behavioral: Teach-back Technique, Other: Standard of Carestandard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique session reviewing information on the hearing aids |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing-Aid Informational GuidePrinted take-home guide on hearing aids | Other | SoC plus hearing-aid informational guide |
| Hearing-Aid DVDTake-home DVD about hearing aids | Other | SoC plus hearing aid DVD |
| Teach-back TechniqueCounseling/Educational session using the teach-back technique to review information about their hearing aids | Behavioural | Soc plus teach-back technique |
| Standard of Carestandard of care hearing-aid orientation as provided by clinical audiologist | Other | SoC plus hearing aid DVD, SoC plus hearing-aid informational guide, Soc plus teach-back technique, Standard of care (SoC) |
Primary outcome
Hearing Aid Skills and Knowledge Test
Time frame: 4 weeks after the hearing-aid fitting
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.
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Samantha Lewis, PhD principal investigator
VA Portland Health Care System, Portland, OR
Gabrielle H Saunders principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing-Aid Informational Guide, Hearing-Aid DVD and Teach-back Technique in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Aid Skills and Knowledge Test (time frame: 4 weeks after the hearing-aid fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.