Applying the Use of Motivational Tools to Auditory Rehabilitation

Hearing Loss Clinical Trial

Official title:

Applying the Use of Motivational Tools to Auditory Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843777
• Other study ID #: C1004-P
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: October 6, 2016
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Behavioral:
• Standard-of-Care
the standard of care in audiologic practice
• Treatment
motivational interviewing

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. — View Citation

Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date	No
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.	Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention	No