Hearing LossNCT02842905
Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention
A study testing Fitting Audiologist completion and Participant's Physician completion in people with Hearing Loss, run by University of British Columbia at 1 site in Canada.
Trial summary
Most of us will experience some degree of hearing loss as we get older. It can affect one or both ears and without treatment causes difficulty with following conversations in the home or workplace. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Fitting Audiologist completion and Participant's Physician completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age or older
- Sensorineural hearing loss greater than 25 dB averaged over frequencies 0.5, 1, 2 and 4 KHz; or 2, 3 and 4 KHz on pure tone audiometry in either ear.
- Have used a hearing for up to 21 days after being fitted
Who cannot join
- Age under 55 years
- Unable to follow doctor/audiologist's instructions
- Previous hearing aid use
Trial locations and contacts
1 site in 1 country.
About this study
Most of us will experience some degree of hearing loss as we get older. It can affect one or both ears and without treatment causes difficulty with following conversations in the home or workplace. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly, however they diagnose hearing loss and can recommend hearing aids amongst other treatments for hearing loss. It is undecided whether consulting with a physician in addition to an audiologist will improve user's satisfaction with hearing aids, compared to consulting with an audiologist alone.
The purpose of this study is to determine whether physician involvement (in addition to an audiologist) in the hearing aid fitting process improves users' satisfaction with hearing aids. The study utilizes questionnaires to assess satisfaction with hearing aids. Furthermore, participants decision to keep the purchased hearing aids will be recorded.
Read more
The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and audiologists. A hearing aid suitable for the needs of the participant will be fitted by an audiologist. In the first 21days after the fitting, participants will attend follow-up visits with the audiologists for adjustments to the hearing aids to best meet their specific listening needs. After 21 days, eligible participants will be allocated to either the Control or Test groups. Participants in both groups will be asked to describe the change in their hearing performance related to the use of hearing aids to their audiologist(Control) or Physician (Test) at a follow-up visit. At the study's final visit, participants will be asked to complete a satisfaction-based questionnaire.
The time taken to fit a hearing aid varies depending on the individual needs of the patient. It is estimated that at most 10 visits will be required over 90 days to complete the hearing aid fitting and study processes. These visits will be of 30 minutes duration on average, except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of this time will be specifically related to the study.
The study is intended to determine the satisfaction with hearing aids and consultations with health professionals.
Read the detailed description
Description of study design This study seeks to determine if additional patient benefit is derived from involving the referring physician in the hearing aid fitting process using the Client Oriented Scale of Improvement (COSI) process. The COSI process is a well-known methodology that consists of two consecutive phases: Phase I is completed by the client with the Audiologist either at the time of initial hearing aid fitting or within 21 days thereafter. The patient is asked to list any specific listening environment/situations in which he/she would like to improve his/her hearing with the assistance of wearing hearing aids; Phase II occurs within days 22 to 76 from the day the hearing aid device is fitted and is also normally completed by the patient and the Audiologist. In this phase, the patient indicates any degree of change in the specific listening environment/situations he/she had previously listed (wearing the hearing aid).
Two methods will be used for study purposes to assess patient satisfaction with hearing aid use 77 to 90 days post fitting: (1) the validated SADL questionnaire described previously will be completed by the patient and (2) the number of hearing aids returned up to 90 days post initial fitting will be recorded.
The study will consist of two groups: a control group and a test group. Both groups will undergo Phase I of the COSI process with the fitting Audiologist. Patients in the control group will undergo Phase II of the COSI process as part of their follow up with the audiologist, whereas those in the test group will complete Phase II of the COSI process in a scheduled visit with their referring physician before further follow-up with the audiologist. Participants will be recruited from the investigating audiologists' clinics in Vancouver. The study involvement time for each participant will extend over a period of 90 days.
Routine Clinical Practice A complete hearing aid fitting takes place over the course of several clinic visits each on average 30-45 minutes in duration. These include the initial hearing test and consultation, actual fitting, and any subsequent post-fitting adjustments. During hearing evaluation and post-fitting follow-up sessions, a COSI questionnaire is used by audiologists as part of routine clinical practice to guide optimal hearing aid adjustment to meet the patient's listening needs.
Time schedule The time taken to fit a hearing aid varies depending on the needs of the patient. Very often clients over the age of 55 have problems with dexterity, memory and other health impairments that extend the length of individual consultations. Some patients require more clinic consultations than others. Anecdotally it is estimated that the maximal number of visits required to complete the hearing aid fitting process is 10 visits over 90 days. These visits on average will be of 30 minutes in duration except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process of which 25 minutes will be related to study specific procedures.
Subjects Patients referred by General practitioners or Otolaryngologists for hearing aid fittings to the offices of two Audiologists who meet the inclusion criteria will be provided with details of the study including a participant information and consent form at their initial evaluation.
Study Procedures Recruitment Patients who satisfy the inclusion criteria will be invited to participate in the study and complete a study consent form.
Allocation Consenting patients will be assigned a study ID and randomized into the Control or Test group using a table of random numbers.
Intervention Process Consenting patients will be randomised using a random number table to have a post-fitting visit between days 21 to 60 after the initial hearing aid fitting with an Audiologist (Control group) or the referring Physician (Test Group). At this visit the audiologist or physician will document the degree of hearing change in specific listening environment/situations as a result of hearing aid use by following the COSI questionnaire. This visit will be for a maximum of 30 minutes.
A follow-up visit of this nature is part of routine clinical practice for the participating audiologist. The physician visit is the novel study intervention after which the patient returns for all subsequent follow-ups with the hearing aid fitting audiologist in keeping with routine clinical practice.
Patient data to be collected
Demographics:
- age, sex
Clinical data:
- degree of hearing loss
Data Analysis The primary indicator of patient satisfaction will be the scored 15-item SADL questionnaire. The Statistical Program for the Social Sciences will be used to undertake a t-test or ANOVA comparison of the mean total SADL questionnaire scores in the Control and Test groups. The secondary outcome measure hearing aid returns, will be assessed by Chi-squared tests of the proportion of returned hearing aids returned in both groups.
- Conditions
- Hearing Loss
- Being tested
- Fitting Audiologist completion, Participant's Physician completion
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitting Audiologist completionOther
Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the fitting Audiologist
Participant's Physician completionOther
Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the Participant's Physician
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Fitting Audiologist completion of the Client Outcome Scale of Improvement at a post fitting follow up visit. Receives: Other: Fitting Audiologist completion |
| Test Group | Experimental | Participant's physician completion of the Client Outcome Scale of Improvement at a post fitting follow up visit. Receives: Other: Participant's Physician completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Amplification in Daily Life questionnaire score
Participant determined satisfaction level with the hearing aid based on the Satisfaction with Amplification in Daily Life (SADL) questionnaire score.
Measured: SADL questionnaire completed at patient's final visit or when hearing aid is returned (77-90 days from initial hearing aid fitting)
Secondary outcomes (1)
Proportion of Hearing aid returned
Participant dissatisfaction with the hearing aid based on the proportion of hearing aids returned
Measured: 77-90 day post fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- NexGen Hearing Inc.
- Responsible party
- Principal investigator, Desmond A Nunez, University of British Columbia
- Investigators
- Desmond Nunez, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842905
- Sponsor's protocol ID
- H15-01282
- Status last verified
- Feb 2022
- First submitted
- 13 Jul 2016
- Last updated
- 3 Mar 2022
- Results posted
- No
- Individual data sharing
- Yes: We intend to IPD post publication of the study's findings. We estimate that this will be from July 2019
Publications
Zhao K, Hambley M, Venema T, Marynewich S, McNeely B, Nunez DA. Effect of Physician Consultation on Satisfaction With Hearing Aid Use: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):630-635. doi: 10.1001/jamaoto.2022.0927.
PubMed 35588353
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention
- ClinicalTrials.gov ID
- NCT02842905
- Acronym / sponsor ID
- H15-01282
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- NexGen Hearing Inc.
- Study start
- Jul 2016
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most of us will experience some degree of hearing loss as we get older. It can affect one or both ears and without treatment causes difficulty with following conversations in the home or workplace. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly, however they diagnose hearing loss and can recommend hearing aids amongst other treatments for hearing loss. It is undecided whether consulting with a physician in addition to an audiologist will improve user's satisfaction with hearing aids, compared to consulting with an audiologist alone.
The purpose of this study is to determine whether physician involvement (in addition to an audiologist) in the hearing aid fitting process improves users' satisfaction with hearing aids. The study utilizes questionnaires to assess satisfaction with hearing aids. Furthermore, participants decision to keep the purchased hearing aids will be recorded.
The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and audiologists. A hearing aid suitable for the needs of the participant will be fitted by an audiologist. In the first 21days after the fitting, participants will attend follow-up visits with the audiologists for adjustments to the hearing aids to best meet their specific listening needs. After 21 days, eligible participants will be allocated to either the Control or Test groups. Participants in both groups will be asked to describe the change in their hearing performance related to the use of hearing aids to their audiologist(Control) or Physician (Test) at a follow-up visit. At the study's final visit, participants will be asked to complete a satisfaction-based questionnaire.
The time taken to fit a hearing aid varies depending on the individual needs of the patient. It is estimated that at most 10 visits will be required over 90 days to complete the hearing aid fitting and study processes. These visits will be of 30 minutes duration on average, except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of this time will be specifically related to the study.
The study is intended to determine the satisfaction with hearing aids and consultations with health professionals.
Detailed description
Description of study design This study seeks to determine if additional patient benefit is derived from involving the referring physician in the hearing aid fitting process using the Client Oriented Scale of Improvement (COSI) process. The COSI process is a well-known methodology that consists of two consecutive phases: Phase I is completed by the client with the Audiologist either at the time of initial hearing aid fitting or within 21 days thereafter. The patient is asked to list any specific listening environment/situations in which he/she would like to improve his/her hearing with the assistance of wearing hearing aids; Phase II occurs within days 22 to 76 from the day the hearing aid device is fitted and is also normally completed by the patient and the Audiologist. In this phase, the patient indicates any degree of change in the specific listening environment/situations he/she had previously listed (wearing the hearing aid).
Two methods will be used for study purposes to assess patient satisfaction with hearing aid use 77 to 90 days post fitting: (1) the validated SADL questionnaire described previously will be completed by the patient and (2) the number of hearing aids returned up to 90 days post initial fitting will be recorded.
The study will consist of two groups: a control group and a test group. Both groups will undergo Phase I of the COSI process with the fitting Audiologist. Patients in the control group will undergo Phase II of the COSI process as part of their follow up with the audiologist, whereas those in the test group will complete Phase II of the COSI process in a scheduled visit with their referring physician before further follow-up with the audiologist. Participants will be recruited from the investigating audiologists' clinics in Vancouver. The study involvement time for each participant will extend over a period of 90 days.
Routine Clinical Practice A complete hearing aid fitting takes place over the course of several clinic visits each on average 30-45 minutes in duration. These include the initial hearing test and consultation, actual fitting, and any subsequent post-fitting adjustments. During hearing evaluation and post-fitting follow-up sessions, a COSI questionnaire is used by audiologists as part of routine clinical practice to guide optimal hearing aid adjustment to meet the patient's listening needs.
Time schedule The time taken to fit a hearing aid varies depending on the needs of the patient. Very often clients over the age of 55 have problems with dexterity, memory and other health impairments that extend the length of individual consultations. Some patients require more clinic consultations than others. Anecdotally it is estimated that the maximal number of visits required to complete the hearing aid fitting process is 10 visits over 90 days. These visits on average will be of 30 minutes in duration except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process of which 25 minutes will be related to study specific procedures.
Subjects Patients referred by General practitioners or Otolaryngologists for hearing aid fittings to the offices of two Audiologists who meet the inclusion criteria will be provided with details of the study including a participant information and consent form at their initial evaluation.
Study Procedures Recruitment Patients who satisfy the inclusion criteria will be invited to participate in the study and complete a study consent form.
Allocation Consenting patients will be assigned a study ID and randomized into the Control or Test group using a table of random numbers.
Intervention Process Consenting patients will be randomised using a random number table to have a post-fitting visit between days 21 to 60 after the initial hearing aid fitting with an Audiologist (Control group) or the referring Physician (Test Group). At this visit the audiologist or physician will document the degree of hearing change in specific listening environment/situations as a result of hearing aid use by following the COSI questionnaire. This visit will be for a maximum of 30 minutes.
A follow-up visit of this nature is part of routine clinical practice for the participating audiologist. The physician visit is the novel study intervention after which the patient returns for all subsequent follow-ups with the hearing aid fitting audiologist in keeping with routine clinical practice.
Patient data to be collected
Demographics:
- age, sex
Clinical data:
- degree of hearing loss
Data Analysis The primary indicator of patient satisfaction will be the scored 15-item SADL questionnaire. The Statistical Program for the Social Sciences will be used to undertake a t-test or ANOVA comparison of the mean total SADL questionnaire scores in the Control and Test groups. The secondary outcome measure hearing aid returns, will be assessed by Chi-squared tests of the proportion of returned hearing aids returned in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Fitting Audiologist completionFitting Audiologist completion of the Client Outcome Scale of Improvement at a post fitting follow up visit. |
| Test Group | Experimental | Other: Participant's Physician completionParticipant's physician completion of the Client Outcome Scale of Improvement at a post fitting follow up visit. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 55 years of age or older
- Sensorineural hearing loss greater than 25 dB averaged over frequencies 0.5, 1, 2 and 4 KHz; or 2, 3 and 4 KHz on pure tone audiometry in either ear.
- Have used a hearing for up to 21 days after being fitted
Key exclusion criteria (3 listed)
- Age under 55 years
- Unable to follow doctor/audiologist's instructions
- Previous hearing aid use
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 |
|---|---|---|
| Fitting Audiologist completionPhase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the fitting Audiologist | Other | Control Group |
| Participant's Physician completionPhase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the Participant's Physician | Other | Test Group |
Primary outcome
Satisfaction with Amplification in Daily Life questionnaire score
Time frame: SADL questionnaire completed at patient's final visit or when hearing aid is returned (77-90 days from initial hearing aid fitting)
Participant determined satisfaction level with the hearing aid based on the Satisfaction with Amplification in Daily Life (SADL) questionnaire score.
1 secondary outcome
Proportion of Hearing aid returned
Time frame: 77-90 day post fitting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 35588353Zhao K, Hambley M, Venema T, Marynewich S, McNeely B, Nunez DA. Effect of Physician Consultation on Satisfaction With Hearing Aid Use: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):630-635. doi: 10.1001/jamaoto.2022.0927.
- Individual participant dataSharing planned: Yes. We intend to IPD post publication of the study's findings. We estimate that this will be from July 2019
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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.
Desmond Nunez, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitting Audiologist completion and Participant's Physician completion in people with Hearing Loss, run by University of British Columbia at 1 site in Canada.
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 3 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 3 Mar 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction with Amplification in Daily Life questionnaire score (time frame: SADL questionnaire completed at patient's final visit or when hearing aid is returned (77-90 days from initial hearing aid fitting)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02842905, which also lists 1 linked publication.
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 3 Mar 2022.