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Trial registered on ANZCTR
Registration number
ACTRN12611000234910
Ethics application status
Approved
Date submitted
28/02/2011
Date registered
3/03/2011
Date last updated
3/03/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Identifying issues affecting expectation in aged patients on the use of hearing aids.
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Scientific title
Using questionnaires to identify issues affecting expectation in aged patients on the use of hearing aids.
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Secondary ID [1]
259691
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Nil
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Secondary ID [2]
259708
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Expectation about hearing aid use
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
This study is about the expectation of hearing impaired and aged patients. We want to know what affecting the expectations of this patients has on the use of hearing aids.
261264
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Condition category
Condition code
Ear
259417
259417
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0
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
People who participated of this study are submited to two questionnaires to evaluation their expectation (one created specially for this study), handicap (HHIE-S), an anamnesis to know age, gender and situations of hearing impairment and also degree of hearing loss (basic audiological evaluation), etc. Totally, we used two questionnaires and the application time of each questionnaires was around 15 to 20 minutes. The study lasted two months.
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Intervention code [1]
264119
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Other interventions
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Intervention code [2]
264136
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Behaviour
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Comparator / control treatment
nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
262225
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To know what is really important at the moment that patients decide to use hearing aids, and which issues will be affecting their expectations about this.
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Assessment method [1]
262225
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Timepoint [1]
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Only before the hearing aid fitting.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
Have neurosensorial hearing loss for mild to moderately-severe degree, bilateral and symmetric and have no experiences with hearing aid use before.
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Minimum age
60
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Other type anda degree of hearing loss, have some cognitive problems that affect the understanding of the questionnaire, and have some experience with hearing aid use before.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3240
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Brazil
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State/province [1]
3240
0
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Funding & Sponsors
Funding source category [1]
258578
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University
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Name [1]
258578
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University of Santa Maria
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Address [1]
258578
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Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
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Country [1]
258578
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Brazil
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Primary sponsor type
University
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Name
University of Santa Maria
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Address
Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
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Country
Brazil
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Secondary sponsor category [1]
263718
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None
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Name [1]
263718
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Nil
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Address [1]
263718
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Nil
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Country [1]
263718
0
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Other collaborator category [1]
251836
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Individual
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Name [1]
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Profa. Dra. Anaelena Braganca de Moraes
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Address [1]
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Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
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Country [1]
251836
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Brazil
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Other collaborator category [2]
251837
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Individual
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Name [2]
251837
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Fga. Ms. Sineia Neujahr dos Santos
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Address [2]
251837
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Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
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Country [2]
251837
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Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260564
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Research Ethics Committee
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Ethics committee address [1]
260564
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Campus Universitario Roraimas Avenue, 1000 Santa Maria/RS CEP: 97119-900
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Ethics committee country [1]
260564
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Brazil
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Date submitted for ethics approval [1]
260564
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Approval date [1]
260564
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05/12/2006
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Ethics approval number [1]
260564
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0138.0.243.000-06
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Summary
Brief summary
Before the hearing aid fitting people answere some questionnaire to evaluate their handicap and expectations. We want to know about gender, age, school degree ansdoccupation too.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32279
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Address
32279
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Country
32279
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Phone
32279
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Fax
32279
0
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Email
32279
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Contact person for public queries
Name
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Larissa Cristina Schuster
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Address
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Duque de Caxias Street, 1505/308
Santa Maria/RS - Centro
CEP: 97.015-190
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Country
15526
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Brazil
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Phone
15526
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(55)81176015
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Fax
15526
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Email
15526
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[email protected]
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Contact person for scientific queries
Name
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Larissa Cristina Schuster
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Address
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Duque de Caxias Street, 1505/308
Santa Maria - Centro
CEP: 97.015-190
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Country
6454
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Brazil
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Phone
6454
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(55)81176015
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Fax
6454
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Email
6454
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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