Clinical Trial of the "Living Well With Hearing Loss Workshop"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00323427
First received: May 5, 2006
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: September 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hearing Loss
Stress
Interventions: Behavioral: The Living Well with Hearing Loss Workshop
Device: hearing aid services

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group Aural Rehabilitation Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
Hearing Aids Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services

Participant Flow:   Overall Study
    Group Aural Rehabilitation     Hearing Aids  
STARTED     69     66  
COMPLETED     38     43  
NOT COMPLETED     31     23  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1 Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
Arm 2 Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  69     66     135  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     20     53  
>=65 years     36     46     82  
Age  
[units: years]
Mean ± Standard Deviation
  67.0  ± 9.8     71.1  ± 8.4     69.0  ± 9.3  
Gender  
[units: participants]
     
Female     0     1     1  
Male     69     65     134  
Region of Enrollment  
[units: participants]
     
United States     69     66     135  



  Outcome Measures
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1.  Primary:   Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale   [ Time Frame: 8 weeks post-baseline relative to baseline ]

2.  Primary:   Communication Profile for Hearing Impaired: Verbal Strategies Subscale   [ Time Frame: 8 weeks post-baseline relative to baseline ]

3.  Primary:   Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale   [ Time Frame: 8-weeks post-baseline relative to baseline ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Mitchel Turbin, Ph.D.
Organization: Portland VA Medical Center
phone: 503-220-8262 ext 54525
e-mail: bonnie.becker@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00323427     History of Changes
Other Study ID Numbers: C4185-R
Study First Received: May 5, 2006
Results First Received: September 26, 2013
Last Updated: January 17, 2014
Health Authority: United States: Federal Government