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Applying the Use of Motivational Tools to Auditory Rehabilitation

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ClinicalTrials.gov Identifier: NCT01843777
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Hearing Loss
Interventions: Behavioral: Standard-of-Care
Behavioral: Treatment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three subjects were consented but not enrolled into the study because they did not meet the inclusion criteria. One subject withdrew from the study after enrollment but prior to randomization.

Reporting Groups
  Description
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.

Standard-of-Care: the standard of care in audiologic practice
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.

Treatment: motivational interviewing

Participant Flow:   Overall Study
    Standard-of-Care   Treatment
STARTED   11 [1]   10 [2] 
Per Protocol Population   11   9 [3] 
COMPLETED   10 [4]   10 [5] 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 
[1] Number of participants randomized to standard-of-care.
[2] Number of participants randomized to treatment.
[3] A subject was randomized to treatment but received standard of care and is not in the analyses.
[4] Final number of standard-of-care participants.
[5] Number of subjects who received the treatment that completed collection of outcome measures



  Baseline Characteristics

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.
Per protocol population reported: One subject randomized to the “Treatment” erroneously received “Standard of Care” and is not included in this baseline report.

Reporting Groups
  Description
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.

Standard-of-Care: the standard of care in audiologic practice
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.

Treatment: motivational interviewing
Total Total of all reporting groups

Baseline Measures
   Standard-of-Care   Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 11   9   20 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   3   3   6 
>=65 years   8   6   14 
Gender 
[Units: Participants]
 		     
Female   1   0   1 
Male   10   9   19 
Region of Enrollment 
[Units: Participants]
 		     
United States   11   9   20 


  Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: M. Samantha Lewis, PhD
Organization: National Center for Rehabilitative Auditory Research
phone: 503-220-8262 ext 51996
e-mail: Michele.Lewis3@va.gov


Publications of Results:

Other Publications:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01843777     History of Changes
Other Study ID Numbers: C1004-P
First Submitted: April 23, 2013
First Posted: May 1, 2013
Results First Submitted: October 6, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016