NCT00126113

Brief Summary

The purpose of the study is to determine whether a new test of ability to understand speech in noise and an associated counseling program can improve hearing aid satisfaction. Participants complete routine hearing tests, some hearing-related questionnaires and the new speech test. One group of participants receives the new form of counseling, the second group does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2005

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

First Submitted

Initial submission to the registry

August 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

3.3 years

First QC Date

August 1, 2005

Results QC Date

September 26, 2014

Last Update Submit

October 6, 2014

Conditions

Hearing Impairment

Keywords

Audiologic rehabilitationCounseling

Outcome Measures

Primary Outcomes (1)

  • Psychosocial Impact of Assistive Devices Scale (PIADS)

    PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being.

    Day 70 (end of study) only

Secondary Outcomes (3)

  • Hearing Handicap Inventory (HHI)

    Day 70 (end of study)

  • Abbreviated Profile of Hearing Aid Benefit (APHAB)

    Day 70 (end of study)

  • International Outcome Inventory for Hearing Aids (IOI-HA)

    Day 70 (end of study)

Study Arms (2)

PPT-based Counseling

EXPERIMENTAL

Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS

Behavioral: PPT-based Counseling

Standard Educational Counseling

OTHER

Standard educational counseling consisting of explanation of hearing tests

Behavioral: Standard Educational Counseling

Interventions

PPT-based CounselingBEHAVIORAL

Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS

PPT-based Counseling
Standard Educational CounselingBEHAVIORAL

Standard educational counseling consisting of explanation of hearing tests

Standard Educational Counseling

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild-to-moderate symmetrical sensorineural hearing loss
  • Current users of binaural hearing aids

You may not qualify if:

  • Conductive hearing impairment or other otological pathology
  • A score less than age-based norms on the Mini Mental State Examination
  • Asymmetrical hearing loss
  • No prior use of hearing aids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

Related Publications (1)

  • Saunders GH, Forsline A. Hearing-aid counseling: comparison of single-session informational counseling with single-session performance-perceptual counseling. Int J Audiol. 2012 Oct;51(10):754-64. doi: 10.3109/14992027.2012.699200. Epub 2012 Jul 19.

    PMID: 22812927RESULT

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Gabrielle Saunder Ph.D.
Organization
National Center for Rehabilitative Auditory Research
gabrielle.saunders@va.gov
503-220-8262

Study Officials

  • Gabrielle H Saunders

    VA Medical Center, Portland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

August 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

October 16, 2014

Results First Posted

October 6, 2014

Record last verified: 2014-10

Locations

US(1)