Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention
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|ClinicalTrials.gov Identifier: NCT02842905|
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : May 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Other: Fitting Audiologist completion Other: Participant's Physician completion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Active Comparator: Control Group
Fitting Audiologist completion of the Client Outcome Scale of Improvement at a post fitting follow up visit.
Other: Fitting Audiologist completion
Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the fitting Audiologist
Experimental: Test Group
Participant's physician completion of the Client Outcome Scale of Improvement at a post fitting follow up visit.
Other: Participant's Physician completion
Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the Participant's Physician
- 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.
- Proportion of Hearing aid returned [ Time Frame: 77-90 day post fitting ]Participant dissatisfaction with the hearing aid based on the proportion of hearing aids returned
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842905
|Contact: Kevin Zhaofirstname.lastname@example.org|
|Contact: Desmond Nunez, MD||604 875 email@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: Kevin Zhao, MD 7789296191 firstname.lastname@example.org|
|Principal Investigator:||Desmond Nunez, MD||University of British Columbia|