Trial Outcomes & Findings for The Performance-Perceptual Test as a Counseling Tool (NCT NCT00126113)
NCT ID: NCT00126113
Last Updated: 2014-10-16
Results Overview
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.
COMPLETED
NA
74 participants
Day 70 (end of study) only
2014-10-16
Participant Flow
Dissatisfied hearing aid users recruited from Portland VA Medical Center Audiology Clinic. Recruitment dates: 1/1/06 to 9/1/07
Exclusion criteria were: Hearing aid dissatisfaction associated with physical fit of the hearing aids, conductive hearing loss, had not worn hearing aids for at least 3 months prior to participating, had mini mental status examination score below age and educationally-appropriate norms.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Performance-Perceptual Test as a Counseling Tool
Baseline characteristics by cohort
| Measure |
PPT-based Counseling
n=37 Participants
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
|
Standard Educational Counseling
n=37 Participants
Standard educational counseling consisting of explanation of hearing tests
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Hearing sensitivity (pure tone thresholds)
|
45.0 decibels
STANDARD_DEVIATION 11.6 • n=5 Participants
|
46.4 decibels
STANDARD_DEVIATION 11.0 • n=7 Participants
|
45.7 decibels
STANDARD_DEVIATION 113 • n=5 Participants
|
|
Education level
|
15.4 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
15.3 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Past hearing aid use
|
8.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
9.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
9.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 70 (end of study) onlyPIADS: 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.
Outcome measures
| Measure |
PPT-based Counseling
n=34 Participants
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
|
Standard Educational Counseling
n=35 Participants
Standard educational counseling consisting of explanation of hearing tests
|
|---|---|---|
|
Psychosocial Impact of Assistive Devices Scale (PIADS)
|
1.06 units on a scale
Standard Deviation 0.79
|
0.85 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
PPT-based Counseling
n=34 Participants
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
|
Standard Educational Counseling
n=35 Participants
Standard educational counseling consisting of explanation of hearing tests
|
|---|---|---|
|
Hearing Handicap Inventory (HHI)
|
38.0 units on a scale
Standard Deviation 19.4
|
34.7 units on a scale
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
PPT-based Counseling
n=34 Participants
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
|
Standard Educational Counseling
n=35 Participants
Standard educational counseling consisting of explanation of hearing tests
|
|---|---|---|
|
Abbreviated Profile of Hearing Aid Benefit (APHAB)
|
26.3 units on a scale
Standard Deviation 15.2
|
21.9 units on a scale
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
PPT-based Counseling
n=34 Participants
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
|
Standard Educational Counseling
n=35 Participants
Standard educational counseling consisting of explanation of hearing tests
|
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
|
26.6 units on a scale
Standard Deviation 4.2
|
25.5 units on a scale
Standard Deviation 4.8
|
Adverse Events
PPT-based Counseling
Standard Educational Counseling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gabrielle Saunder Ph.D.
National Center for Rehabilitative Auditory Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place