The Performance-Perceptual Test as a Counseling Tool (PPT)
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| ClinicalTrials.gov Identifier: NCT00126113 |
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Recruitment Status :
Completed
First Posted : August 2, 2005
Results First Posted : October 6, 2014
Last Update Posted : October 16, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hearing Impairment | Behavioral: PPT-based Counseling Behavioral: Standard Educational Counseling | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Official Title: | The Performance-Perceptual Test as a Counseling Tool |
| Study Start Date : | August 2005 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | November 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PPT-based Counseling
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
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Behavioral: PPT-based Counseling
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS |
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Standard Educational Counseling
Standard educational counseling consisting of explanation of hearing tests
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Behavioral: Standard Educational Counseling
Standard educational counseling consisting of explanation of hearing tests |
- Psychosocial Impact of Assistive Devices Scale (PIADS) [ Time Frame: Day 70 (end of study) only ]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.
- Hearing Handicap Inventory (HHI) [ Time Frame: Day 70 (end of study) ]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).
- Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Day 70 (end of study) ]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).
- International Outcome Inventory for Hearing Aids (IOI-HA) [ Time Frame: Day 70 (end of study) ]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).
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| Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT00126113
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
| Principal Investigator: | Gabrielle H Saunders | VA Medical Center, Portland |
Publications of Results:
| Responsible Party: | US Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00126113 |
| Other Study ID Numbers: |
C3951-R 05-2504 ( Other Identifier: Portland VA IRB ) 11-2104 ( Other Identifier: Portland VA IRB ) |
| First Posted: | August 2, 2005 Key Record Dates |
| Results First Posted: | October 6, 2014 |
| Last Update Posted: | October 16, 2014 |
| Last Verified: | October 2014 |
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Audiologic rehabilitation Counseling |
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Hearing Loss Deafness Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |