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Hearing Health Care Service Access and Use

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ClinicalTrials.gov Identifier: NCT02037139
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Hearing loss screening rates in for older persons in primary care clinics are very low even though hearing loss is relatively common for older persons. When diagnosed with hearing loss older persons are often reluctant to follow through. This study involves a prospective controlled trial comparing the effectiveness of three primary care based protocols for older adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to and use of hearing health care services. The protocols will compare: 1) screening only (standard care control); 2) screening plus an illustrated educational brochure; and 3) screening plus an in-person educational intervention and an illustrated educational brochure. Screening will be done by primary care personnel. Participants will be tracked for 8 months to assess outcomes.

Condition or disease Intervention/treatment Phase
Hearing Loss Other: Screening Other: Brochure Behavioral: Education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Primary Care Intervention Promoting Hearing Health Care Service Access and Use
Actual Study Start Date : July 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control (screening)
screening only (standard care control)
Other: Screening
Standard care screening

Active Comparator: Educational brochure
Screening + illustrated educational brochure
Other: Screening
Standard care screening

Other: Brochure
Participants are given an illustrated educational brochure

Experimental: Education
Screening + illustrated educational brochure + an in-person educational intervention
Other: Screening
Standard care screening

Other: Brochure
Participants are given an illustrated educational brochure

Behavioral: Education
Participants undergo a in-person educational intervention




Primary Outcome Measures :
  1. Referral rates for hearing evaluation [ Time Frame: 8 months after initial screening ]
    Proportion of those who screened positive for possible hearing loss who follow through on clinic recommendations for referrals or who elect a referral on their own


Secondary Outcome Measures :
  1. Number of changes made to improve hearing [ Time Frame: 8 months after initial screening ]
    Other than adopting hearing aids, how many changes did participants make to improve their hearing since screened. Education segment lists 6 possible changes.


Other Outcome Measures:
  1. Hearing outcomes [ Time Frame: 8 months following initial screening ]
    Improvement in hearing over the course of the study as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S) and Inner Ear scales



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 60 or older
  • Not currently wearing a hearing aid
  • Cognitively capable of giving informed consent
  • Able to speak and understand English
  • No concurrent health problem that would limit participation
  • Screen positive for hearing loss using single question and/or finger rub

Exclusion Criteria:

  • Age 59 or less
  • Currently wearing a hearing aid
  • Cognitively impaired or not cognitively capable of giving informed consent
  • Unable to speak and understand English
  • Has a concurrent health condition that limits participation
  • Does not screen positive for hearing loss

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): NCT02037139


Contacts
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Contact: Margaret I Wallhagen, PhD, RN 415 376 4965 meg.wallhagen@ucsf.edu
Contact: William J Strawbridge, PhD, MPH 415 514 3994 bill.strawbridge@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Margaret I Wallhagen, PhD, RN    415-476-4965    meg.wallhagen@ucsf.edu   
Contact: William J Strawbridge, PhD, MPH    415 514 3994    bill.strawbridge@ucsf.edu   
Principal Investigator: Margaret I Wallhagen, PhD, RN         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Margaret I Wallhagen University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02037139     History of Changes
Other Study ID Numbers: 4R33DC011510-03 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of California, San Francisco:
Hearing loss
Screening
Primary Care

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms