Applying the Use of Motivational Tools to Auditory Rehabilitation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01843777
First received: April 23, 2013
Last updated: April 1, 2014
Last verified: April 2014

April 23, 2013
April 1, 2014
November 2013
September 2015   (final data collection date for primary outcome measure)
Hours of Hearing Aid Use [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
The primary outcome measure will be hearing-aid use, measured by the number of hours of use recorded in the hearing-aid software.
Same as current
Complete list of historical versions of study NCT01843777 on ClinicalTrials.gov Archive Site
  • Hearing Aid Outcomes [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
    Outcomes will be assessed using the International Outcome Inventory for Hearing Aids (Cox et al., 2000)
  • Self-efficacy [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
    Two questionnaires will be used to assess self-efficacy - the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA; West & Smith, 2007) and the Listening Self-Efficacy Questionnaire (LSEQ; Smith, Pichora-Fuller, Watts & La More, 2011).
  • Importance [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
    subject report
  • Readiness for change [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
    subject report
  • Hearing Aid Outcomes [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
    Outcomes will be assessed using the International Outcome Inventory for Hearing Aids (Cox et al., 2000)
  • Self-efficacy [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
    Two questionnaires will be used to assess self-efficacy - the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA; West & Smith, 2007) and the Listening Self-Efficacy Questionnaire (LSEQ; Smith, Pichora-Fuller, Watts & La More, 2011).
  • Importance [ Time Frame: the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA; West & Smith, 2007) and the Listening Self-Efficacy Questionnaire (LSEQ; Smith, Pichora-Fuller, Watts & La More, 2011). ] [ Designated as safety issue: No ]
  • Readiness for change [ Time Frame: Four to six weeks following the intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Applying the Use of Motivational Tools to Auditory Rehabilitation
Applying the Use of Motivational Tools to Auditory Rehabilitation

The purpose of this study is to compare two different ways of helping new 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 that uses tools to address patient-specific barriers against and motivators for hearing-aid use.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Hearing Loss
  • Hearing Aids
  • Rehabilitation
  • Motivational Interviewing
  • Behavioral: Standard-of-Care
    the standard of care in audiologic practice
  • Behavioral: Treatment
    motivational interviewing
    Other Name: Motivational Interviewing
  • Active Comparator: 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.
    Intervention: Behavioral: Standard-of-Care
  • Experimental: 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.
    Intervention: Behavioral: Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
September 2015
September 2015   (final data collection date for primary outcome measure)

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 - Standard Version (Folstein et al., 2010)
  • have been recently fit by the Portland VAMC 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 clinical notes suggesting poor adaptation to their new 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

Both
20 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01843777
C1004-P
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: M. Samantha Lewis, PhD Portland VA Medical Center, Portland, OR
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP