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Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842905
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
NexGen Hearing
Information provided by (Responsible Party):
Desmond A Nunez, University of British Columbia

Brief 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. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age under 55 years
  • Unable to follow doctor/audiologist's instructions
  • Previous hearing aid use

Information from the National Library of Medicine

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


Contacts
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Contact: Kevin Zhao 7789296191 kevin.zhao@alumni.ubc.ca
Contact: Desmond Nunez, MD 604 875 4664 desmond.nunez@ubc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Kevin Zhao, MD    7789296191    kevin.zhao@alumni.ubc.ca   
Sponsors and Collaborators
University of British Columbia
NexGen Hearing
Investigators
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Principal Investigator: Desmond Nunez, MD University of British Columbia

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Responsible Party: Desmond A Nunez, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02842905    
Other Study ID Numbers: H15-01282
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We intend to IPD post publication of the study's findings. We estimate that this will be from July 2019
Supporting Materials: Clinical Study Report (CSR)
Time Frame: From July 2019- June 2020
Access Criteria: By contacting corresponding author in peer reviewed publication.
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms