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Applying the Use of Motivational Tools to Auditory Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01843777
First received: April 23, 2013
Last updated: October 6, 2016
Last verified: October 2016

April 23, 2013
October 6, 2016
November 2013
March 2015   (final data collection date for primary outcome measure)
Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention [ Time Frame: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01843777 on ClinicalTrials.gov Archive Site
Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids [ Time Frame: Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention ] [ Designated as safety issue: No ]
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.
  • 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 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hearing Loss
  • 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.
 
Completed
25
March 2015
March 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 - 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

Both
20 Years to 89 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01843777
C1004-P
No
No
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: M. Samantha Lewis, PhD VA Portland Health Care System, Portland, OR
VA Office of Research and Development
October 2016

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