NCT02037139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

6.2 years

First QC Date

January 13, 2014

Last Update Submit

November 12, 2019

Conditions

Hearing Loss

Keywords

Hearing lossScreeningPrimary Care

Outcome Measures

Primary Outcomes (1)

  • Referral rates for hearing evaluation

    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

    8 months after initial screening

Secondary Outcomes (1)

  • Number of changes made to improve hearing

    8 months after initial screening

Other Outcomes (1)

  • Hearing outcomes

    8 months following initial screening

Study Arms (3)

Control (screening)

ACTIVE COMPARATOR

screening only (standard care control)

Other: Screening

Educational brochure

ACTIVE COMPARATOR

Screening + illustrated educational brochure

Other: ScreeningOther: Brochure

Education

EXPERIMENTAL

Screening + illustrated educational brochure + an in-person educational intervention

Other: ScreeningOther: BrochureBehavioral: Education

Interventions

ScreeningOTHER

Standard care screening

Control (screening)EducationEducational brochure
BrochureOTHER

Participants are given an illustrated educational brochure

EducationEducational brochure
EducationBEHAVIORAL

Participants undergo a in-person educational intervention

Education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Mass ScreeningEducational Status

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticeSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Margaret I Wallhagen

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

July 1, 2013

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)