Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Performance-Perceptual Test as a Counseling Tool (PPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00126113
First received: August 1, 2005
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Hearing Impairment
Behavioral: PPT-based Counseling
Behavioral: Standard Educational Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Performance-Perceptual Test as a Counseling Tool

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Psychosocial Impact of Assistive Devices Scale (PIADS) [ Time Frame: Day 70 (end of study) only ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Hearing Handicap Inventory (HHI) [ Time Frame: Day 70 (end of study) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 74
Study Start Date: August 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PPT-based Counseling
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
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
Behavioral: Standard Educational Counseling
Standard educational counseling consisting of explanation of hearing tests

Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126113

Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Investigators
Principal Investigator: Gabrielle H Saunders VA Medical Center, Portland
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00126113     History of Changes
Other Study ID Numbers: C3951-R, 05-2504, 11-2104
Study First Received: August 1, 2005
Results First Received: September 26, 2014
Last Updated: October 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Audiologic rehabilitation
Counseling

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

ClinicalTrials.gov processed this record on November 19, 2014