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: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hearing Loss
Hearing Aids
Rehabilitation
Motivational Interviewing
Behavioral: Standard-of-Care
Behavioral: Treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Applying the Use of Motivational Tools to Auditory Rehabilitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Standard-of-Care
the standard of care in audiologic practice
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.
Behavioral: Treatment
motivational interviewing
Other Name: Motivational Interviewing

  Eligibility

Ages Eligible for Study:   20 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843777

Locations
United States, Oregon
Portland VA Medical Center, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Investigators
Principal Investigator: M. Samantha Lewis, PhD Portland VA Medical Center, Portland, OR
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01843777     History of Changes
Other Study ID Numbers: C1004-P
Study First Received: April 23, 2013
Last Updated: September 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hearing loss
hearing aids
motivational interviewing
counseling
rehabilitation

Additional relevant MeSH terms:
Deafness
Hearing Loss
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014