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Hearing Aids, Counseling and the Significant Other

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ClinicalTrials.gov Identifier: NCT01809496
Recruitment Status : Terminated (Funding ended)
First Posted : March 12, 2013
Last Update Posted : December 9, 2014
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
M. Samantha Lewis, Ph.D., VA National Center for Rehabilitative Auditory Research

Brief Summary:
The purpose of this study is to examine the effect of enhanced patient-centered counseling (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid outcomes.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: Informational Counseling Behavioral: Patient Centered Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Auditory Rehabilitation From the Perspective of the Significant Other
Study Start Date : March 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Informational counseling, patient only
The purpose of this experimental group is to evaluate the effectiveness of informational counseling alone. This type of counseling is considered the standard of care in audiologic practice. Patients in this will review this material in detail with a member of the study team for approximately 30 minutes at the second visit. Spouses in this experimental group will be will review material regarding VA services with a member of the study team for about 30 minutes.
Behavioral: Informational Counseling
Experimental: Informational Counseling, couples
The purpose of this experimental group is to evaluate the influence of spousal involvement when receiving informational counseling. In this manner, both patients and spouses are presented with the same information regarding hearing loss and hearing aids. Couples in this experimental group will be given the same information that the patients in the first group were given. At the second visit, couples in this group will review this information together with a member of the research team for approximately 30 minutes.
Behavioral: Informational Counseling
Experimental: Patient Centered Counseling,patient only
In order to assess the effects of enhanced patient-centered counseling (PCC), the patients assigned to this group will meet together with either Dr. Lewis or the Research Audiologist for approximately 30 minutes of counseling. In addition to the PCC techniques used in audiology, this counseling also will involve the core components of motivational interviewing. These principles and methods will be used to allow the patient to clearly express his/her expectations of, concerns about, and motivations for hearing-aid use. The spouses in this experimental group will be given information regarding VA services. This material will be reviewed with a member of the research team for about 30 minutes at the second visit.
Behavioral: Patient Centered Counseling
Other Name: motivational interviewing

Experimental: Patient Centered Counseling, couples
In order to assess the influence of the spouse on the enhanced PCC process, the couples assigned to this group will meet together with either Dr. Lewis or the Research Audiologist for approximately 30 minutes of counseling. This counseling will be conducted with both the patient and the spouse together, giving both partners time to express their thoughts.
Behavioral: Patient Centered Counseling
Other Name: motivational interviewing




Primary Outcome Measures :
  1. post-use subjective opinions regarding the hearing aids [ Time Frame: 4-6 weeks after the hearing aid fitting ]
    questionnaires


Secondary Outcome Measures :
  1. pre-use hearing aid expectations [ Time Frame: immediately after the intervention at Visit #2 (Day 0) ]
    questionnaire


Other Outcome Measures:
  1. self-efficacy [ Time Frame: 4-6 weeks after the hearing aid fitting ]
    questionnaires

  2. hearing aid use [ Time Frame: 4-6 weeks after the hearing aid fitting ]
    datalogging



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Both men and women with hearing loss and their live-in partners will serve as subjects in this study. The subjects with hearing loss will have a mild to moderately-severe hearing loss in both of the ears, will have word recognition scores of 40% or better bilaterally, and will be about to get new hearing aids. Live-in partners may also have up to a moderately-severe degree of hearing loss but cannot have prior experience with hearing aids nor have plans to get hearing aids during the course of their participation in this study. Their word recognition scores should also be 40% or better bilaterally. All subjects also will meet the following additional inclusion criteria:

  1. Age 20-85 years;
  2. Intact mental status as assessed by the Mini-Mental State Examination (MMSE; Folstein, Folstein & McHugh, 1975);
  3. No evidence of any major medical illness requiring long-term assistive care, as determined by the Katz Index of Independence in Activities of Daily Living (Katz, Down, Cash &Grotz, 1970);
  4. Able to read and respond to English; and
  5. Willing and able to give written informed consent to participate in this investigation.

Exclusion Criteria: Failure to satisfy any of the requirements listed above or if their live-in partner fails to meet the criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809496


Locations
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United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97207
Sponsors and Collaborators
VA National Center for Rehabilitative Auditory Research
US Department of Veterans Affairs
Investigators
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Principal Investigator: M. Samantha Lewis, PhD VA National Center for Rehabilitative Auditory Research

Publications:
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Responsible Party: M. Samantha Lewis, Ph.D., Principal Investigator, VA National Center for Rehabilitative Auditory Research
ClinicalTrials.gov Identifier: NCT01809496     History of Changes
Other Study ID Numbers: C7067W
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by M. Samantha Lewis, Ph.D., VA National Center for Rehabilitative Auditory Research:
hearing loss
hearing aids
spouses
rehabilitation

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