Hearing ImpairmentPPTNCT00126113
The Performance-Perceptual Test as a Counseling Tool
A study testing PPT-based Counseling and Standard Educational Counseling in people with Hearing Impairment, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- PPT-based Counseling and Standard Educational Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-to-moderate symmetrical sensorineural hearing loss
- Current users of binaural hearing aids
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hearing Impairment
- Being tested
- PPT-based Counseling, Standard Educational Counseling
- Keywords
- Audiologic rehabilitation, Counseling
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPT-based CounselingBehavioural
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
Standard Educational CounselingBehavioural
Standard educational counseling consisting of explanation of hearing tests
| Study group | Role | What they receive |
|---|---|---|
| PPT-based Counseling | Experimental | Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS Receives: Behavioral: PPT-based Counseling |
| Standard Educational Counseling | Other | Standard educational counseling consisting of explanation of hearing tests Receives: Behavioral: Standard Educational Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 70 (end of study) only
Secondary outcomes (3)
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).
Measured: Day 70 (end of study)
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).
Measured: Day 70 (end of study)
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).
Measured: Day 70 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gabrielle H Saunders, Principal investigator, VA Medical Center, Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126113
- Sponsor's protocol ID
- C3951-R
- Other IDs
- 05-2504, 11-2104
- Acronym
- PPT
- Status last verified
- Oct 2014
- First submitted
- 1 Aug 2005
- Last updated
- 16 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22812927
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance-Perceptual Test as a Counseling Tool
- ClinicalTrials.gov ID
- NCT00126113
- Acronym / sponsor ID
- PPT / C3951-R
- Conditions
- Hearing Impairment
- Keywords
- Audiologic rehabilitation, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Aug 2005 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPT-based Counseling | Experimental | Behavioral: PPT-based CounselingCounseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS |
| Standard Educational Counseling | Other | Behavioral: Standard Educational CounselingStandard educational counseling consisting of explanation of hearing tests |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild-to-moderate symmetrical sensorineural hearing loss
- Current users of binaural hearing aids
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPT-based CounselingCounseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS | Behavioural | PPT-based Counseling |
| Standard Educational CounselingStandard educational counseling consisting of explanation of hearing tests | Behavioural | Standard Educational Counseling |
Primary outcome
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.
3 secondary outcomes
Hearing Handicap Inventory (HHI)
Time frame: Day 70 (end of study)
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Day 70 (end of study)
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: Day 70 (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22812927Saunders 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle H Saunders principal investigator
VA Medical Center, Portland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPT-based Counseling and Standard Educational Counseling in people with Hearing Impairment, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial Impact of Assistive Devices Scale (PIADS) (time frame: Day 70 (end of study) only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00126113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.