Hearing Loss
Conditions
Keywords
hearing loss, hearing aids, motivational interviewing, counseling, rehabilitation
Brief summary
The purpose of this study is to compare two different ways of helping first-time hearing-aid users get the most out of their hearing aids and determine if one method is better than the other. One method provides the patient with routine information regarding the care and use of hearing aids the other method uses tools to address patient-specific barriers against and motivators for hearing-aid use.
Interventions
BEHAVIORALStandard-of-Care
the standard of care in audiologic practice
BEHAVIORALTreatment
motivational interviewing
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* be aged between 20 and 89 years * be a first-time hearing-aid user * air-conduction pure-tone averages (mean thresholds at 500 Hz, 1000 Hz, and 2000 Hz) of 70 dB HL or less in both ears * word-recognition scores of 40% or better in each ear * English as their first language * have sufficient vision and reading ability * have the appropriate cognitive skills to participate in the study as determined by the Mini Mental State Exam, 2nd Edition - Brief Version (Folstein et al., 2010) * have been fit by the VA Portland Health Care System Audiology and Speech Pathology Service (ASPS) with two hearing aids which have datalogging capabilities * be independent in their completion of activities in daily living, as determined by their score on the Katz Index of Independence in Activities of Daily Living (Katz et al., 1970) * have poor adoption of their hearing aids * be free of a documented diagnosis in the VA Computerized Patient Record System (CPRS) record of neurological or psychological disorder, such as Alzheimer's disease, schizophrenia, or uncontrolled substance abuse, which would interfere with the completion of the study. Vulnerable populations are not being studied.
Exclusion criteria
Failure to satisfy any of the requirements listed as inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention | Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date | Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids | Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention | The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points. |
Countries
United States
Participant flow
Pre-assignment details
Three subjects were consented but not enrolled into the study because they did not meet the inclusion criteria. One subject withdrew from the study after enrollment but prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Standard-of-Care The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.
Standard-of-Care: the standard of care in audiologic practice | 11 |
| Treatment The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.
Treatment: motivational interviewing | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard-of-Care | Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention
Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.
Time frame: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date
Population: Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included.~Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard-of-Care | Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention | -2.1 hours | Standard Deviation 3.3 |
| Treatment | Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention | 2.2 hours | Standard Deviation 3.3 |
Secondary
Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids
The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points.
Time frame: Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention
Population: In the standard-of-care group, one subject withdrew from the study prior to the collection of outcome measures. In the treatment group, one subject did not answer one of the questions on the baseline questionnaire, thereby preventing calculation of a total score. This subject's data is therefore not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard-of-Care | Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids | 1.3 units on a scale | Standard Deviation 2.9 |
| Treatment | Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids | 0.4 units on a scale | Standard Deviation 4.8 |