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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000675022
Ethics application status
Approved
Date submitted
17/08/2010
Date registered
17/08/2010
Date last updated
17/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of an instrument for assessment of expectations of new hearing aid users.
Scientific title
Development of an instrument for assessment of expectations of new hearing aid users, using test-retest approach.
Secondary ID [1] 252467 0
None
Universal Trial Number (UTN)
U1111-1116-6133
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Development of an instrument enabling the measurement of expectations of the patient candidate for hearing aids. 257975 0
Condition category
Condition code
Ear 258140 258140 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application and reapplication of the instrument (questionnaire) in the same group of adults and elderly, with an interval of 7 days between first and last application. The questionnaire consists of 12 questions with issues closed and 3 alternatives of response. It takes aproximately 10 minutes to complete.
Intervention code [1] 257027 0
Rehabilitation
Intervention code [2] 257031 0
Diagnosis / Prognosis
Intervention code [3] 257032 0
Treatment: Devices
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259003 0
The instrument proved be reliable for evaluating the expectation of the new hearing aids user, using the Kappa Coeficient.
Timepoint [1] 259003 0
Application and reapplication 7 days after the first.
Secondary outcome [1] 265234 0
'Nil'
Timepoint [1] 265234 0
'Nil'

Eligibility
Key inclusion criteria
People over 18 years old, with hearing loss of mild to moderately-severe and no experience with hearing aids.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People under 18 years old, with severe or profound bilateral hearing loss and that had any prior experience with hearing aids.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2820 0
Brazil
State/province [1] 2820 0

Funding & Sponsors
Funding source category [1] 257476 0
University
Name [1] 257476 0
Hearning Aids Lab - Federal Univesrsity of Santa Maria
Address [1] 257476 0
Floriano Peixoto Street, 1750 - 7o floor
Post Code: 97.015-372 - Center - Santa Maria - RS
Country [1] 257476 0
Brazil
Primary sponsor type
Individual
Name
Larissa Schuster
Address
Duque de Caxias Street, 1505/308
Post Code: 97.015-190 - Center - Santa Maria - RS
Country
Brazil
Secondary sponsor category [1] 256704 0
None
Name [1] 256704 0
Address [1] 256704 0
Country [1] 256704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259503 0
Ethics Committe of Research
Ethics committee address [1] 259503 0
Roraima Avenue, 1000 - University City
Post Code: 97105-900 - Camobi
Santa Maria - RS
Ethics committee country [1] 259503 0
Brazil
Date submitted for ethics approval [1] 259503 0
Approval date [1] 259503 0
05/12/2006
Ethics approval number [1] 259503 0
019 731

Summary
Brief summary
To verify the confidence of the questionnaire and its replicability using the test-retes approach and statistic analysys by the Kappa Coeficient. Our hypothesis was that the instrument would be reliable and maybe could be used for embased the rehabilitation strategy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31532 0
Address 31532 0
Country 31532 0
Phone 31532 0
Fax 31532 0
Email 31532 0
Contact person for public queries
Name 14779 0
Larissa Schuster
Address 14779 0
Duque de Caxias Street, 1505/308
Post Code: 97.015-190 - Center
Santa Maria -RS
Country 14779 0
Brazil
Phone 14779 0
+55 55 3220 - 9234
Fax 14779 0
Email 14779 0
larissa.schuster@gmail.com
Contact person for scientific queries
Name 5707 0
Larissa Schuster
Address 5707 0
Duque de Caxias Street, 1505/308
Post Code: 97.015-190 - Center
Santa Maria -RS
Country 5707 0
Brazil
Phone 5707 0
+55 55 3220 - 9234
Fax 5707 0
Email 5707 0
larissa.schuster@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary