Trial Outcomes & Findings for Applying the Use of Motivational Tools to Auditory Rehabilitation (NCT NCT01843777)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date

Results posted on

2016-10-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	11	10
Overall Study Per Protocol Population	11	9
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Applying the Use of Motivational Tools to Auditory Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard-of-Care n=11 Participants 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	Treatment n=9 Participants 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	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard-of-Care n=9 Participants 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	Treatment n=5 Participants 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
Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention	-2.1 hours Standard Deviation 3.3	2.2 hours Standard Deviation 3.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard-of-Care n=10 Participants 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	Treatment n=8 Participants 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
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	0.4 units on a scale Standard Deviation 4.8

Adverse Events

Standard-of-Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

M. Samantha Lewis, PhD

National Center for Rehabilitative Auditory Research

Phone: 503-220-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place