Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
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.
Scientific title
Using questionnaires to identify issues affecting expectation in aged patients on the use of hearing aids.
Secondary ID [1] 259691 0
Nil
Secondary ID [2] 259708 0
Expectation about hearing aid use
Universal Trial Number (UTN)
Trial acronym
Linked study record

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 0
Condition category
Condition code
Ear 259417 259417 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 264119 0
Other interventions
Intervention code [2] 264136 0
Behaviour
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262225 0
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.
Timepoint [1] 262225 0
Only before the hearing aid fitting.
Secondary outcome [1] 273352 0
Nil
Timepoint [1] 273352 0
Nil

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.
Minimum age
60 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Educational / counselling / training
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 3240 0
Brazil
State/province [1] 3240 0

Funding & Sponsors
Funding source category [1] 258578 0
University
Name [1] 258578 0
University of Santa Maria
Country [1] 258578 0
Brazil
Primary sponsor type
University
Name
University of Santa Maria
Address
Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
Country
Brazil
Secondary sponsor category [1] 263718 0
None
Name [1] 263718 0
Nil
Address [1] 263718 0
Nil
Country [1] 263718 0
Other collaborator category [1] 251836 0
Individual
Name [1] 251836 0
Profa. Dra. Anaelena Braganca de Moraes
Address [1] 251836 0
Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
Country [1] 251836 0
Brazil
Other collaborator category [2] 251837 0
Individual
Name [2] 251837 0
Fga. Ms. Sineia Neujahr dos Santos
Address [2] 251837 0
Campus Universitario
Roraimas Avenue, 1000
(55) 3220-8659
Santa Maria/RS
CEP: 97119-900
Country [2] 251837 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260564 0
Research Ethics Committee
Ethics committee address [1] 260564 0
Campus Universitario
Roraimas Avenue, 1000
Santa Maria/RS
CEP: 97119-900
Ethics committee country [1] 260564 0
Brazil
Date submitted for ethics approval [1] 260564 0
Approval date [1] 260564 0
05/12/2006
Ethics approval number [1] 260564 0
0138.0.243.000-06

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32279 0
Address 32279 0
Country 32279 0
Phone 32279 0
Fax 32279 0
Email 32279 0
Contact person for public queries
Name 15526 0
Larissa Cristina Schuster
Address 15526 0
Duque de Caxias Street, 1505/308
Santa Maria/RS - Centro
CEP: 97.015-190
Country 15526 0
Brazil
Phone 15526 0
(55)81176015
Fax 15526 0
Email 15526 0
[email protected]
Contact person for scientific queries
Name 6454 0
Larissa Cristina Schuster
Address 6454 0
Duque de Caxias Street, 1505/308
Santa Maria - Centro
CEP: 97.015-190
Country 6454 0
Brazil
Phone 6454 0
(55)81176015
Fax 6454 0
Email 6454 0
[email protected]

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.