The Performance-Perceptual Test as a Counseling Tool

Hearing Impairment Clinical Trial

— PPT  

Official title:

The Performance-Perceptual Test as a Counseling Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126113
• Other study ID #: C3951-R
• Secondary ID: 05-250411-2104
• Status: Completed
• Phase: N/A
• First received: August 1, 2005
• Last updated: October 6, 2014
• Start date: August 2005
• Est. completion date: November 2008

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Hearing aid dissatisfaction continues to be disappointingly high, even though hearing aid technology has improved dramatically over the last 10 years or so. Unfortunately, the results of most commonly used self-report measures cannot be directly compared with the results from performance measures since the modes of testing are very different. Thus, it is hard for clinicians to reconcile data from individuals reporting more handicap or less hearing aid satisfaction than would be expected from their performance.

In this study, the investigators use a test known as the Performance-Perceptual Test (PPT) to determine whether simple counseling based upon discussion of PPT results can be used to better align perceived and measured ability to understand speech-in-noise; and, more importantly, whether such counseling can decrease reported handicap and improve hearing aid satisfaction.

Hearing aid users complete the PPT for aided and unaided listening, along with standardized questionnaires measuring reported auditory disability, handicap and hearing aid satisfaction. Following this, subjects are randomly assigned to one of two groups. Subjects in Group 1 receive counseling from the experimenter in the form of an explanation and discussion of their PPT results. Subjects in Group 2 also participate in a discussion with the experimenter, but it does not include an explanation of the PPT. Two weeks after enrollment in the study subjects complete a second set of questionnaires. Ten weeks after study enrollment subjects return to the laboratory to rerun the test battery. The impact of the counseling upon PPT values, reported handicap and hearing aid satisfaction and benefit will be compared across the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Mild-to-moderate symmetrical sensorineural hearing loss

• Current users of binaural hearing aids

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Behavioral:
• PPT-based Counseling
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
• Standard Educational Counseling
Standard educational counseling consisting of explanation of hearing tests

Locations

Country	Name	City	State
United States	VA Medical Center, Portland	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. Epub 2012 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hearing Handicap Inventory (HHI)	HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap).	Day 70 (end of study)	No
Secondary	Abbreviated Profile of Hearing Aid Benefit (APHAB)	APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ' Always ' to ' Never ' with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability).	Day 70 (end of study)	No
Secondary	International Outcome Inventory for Hearing Aids (IOI-HA)	The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome).	Day 70 (end of study)	No