Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000683730
Ethics application status
Approved
Date submitted
13/06/2013
Date registered
21/06/2013
Date last updated
24/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hearing aid handling skills: relationship with satisfaction and benefit
Scientific title
Hearing aid handling skills: relationship with satisfaction and benefit in hearing impaired individuals
Secondary ID [1] 282663 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing aid handling skills 289362 0
Condition category
Condition code
Ear 289700 289700 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study was to evaluate hearing aid handling skills for new and experienced users and to assess if such skills influence user’s benefit and satisfaction. 74 participants with mean age of 70.43 years were divided in two groups: experienced (n=37) or new hearing aid users (n=37). Both groups performed the tasks of "Practical Hearing Aid Skills Test" (PHAST) which were a test scored on a five-point Likert scale - high scores indicate better hearing aid handling skills. Experienced users also answered the International Outcome Inventory for Hearing Aids (IOI-HA) and the hearing aid benefit for handicap reduction was calculated by the hearing handicap inventory (HHIA/HHIE). A unique evaluator assesses the PHAST and the questionnaires.
It was just one session for one hour and a half to assess the questionnaires and the PHAST for both groups.
Intervention code [1] 287327 0
Rehabilitation
Intervention code [2] 287367 0
Other interventions
Comparator / control treatment
Active control - experienced group (n=37), submitted to PHAST, the International Outcome Inventory for Hearing Aids (IOI-HA) and the hearing aid benefit for handicap reduction was calculated by the Hearing Handicap Inventory (HHIE/HHIA). It was just one session for one hour and a half to assess the questionnaires and the PHAST.
Control group
Active

Outcomes
Primary outcome [1] 289795 0
PHAST (Practical Hearing Aid Skills Test) scores.
Timepoint [1] 289795 0
Immediately after all participants have completed PHAST and the experienced group have also completed the IOI-HA (International Outcome Inventory for Hearing Aids) and the HHIA/HHIE (Hearing Handicap Inventory for the Adults/Elderly).
Secondary outcome [1] 303254 0
Correlations between IOI benefit, quality of life items and PHAST scores.
For this, the PHAST, IOI-HA and HHIA/HHIE were applied.
Timepoint [1] 303254 0
Immediately after all participants have completed PHAST and the experienced group have also completed the IOI-HA (International Outcome Inventory for Hearing Aids) and the HHIA/HHIE (Hearing Handicap Inventory for the Adults/Elderly).

Eligibility
Key inclusion criteria
Hearing impaired individuals that use their hearing aids for more than six months (experienced group) or for less than six months (new users group)
Minimum age
35 Years
Maximum age
88 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with normal hearing and children

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
23/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment outside Australia
Country [1] 5142 0
Brazil
State/province [1] 5142 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 287446 0
Self funded/Unfunded
Name [1] 287446 0
Patricia Danieli Campos
Country [1] 287446 0
Brazil
Primary sponsor type
Individual
Name
Patricia Danieli Campos
Address
University of Sao Paulo
Al Octavio Pinheiro Brisola, 9-75, Vila Universitaria, CEP: 17012-901
Country
Brazil
Secondary sponsor category [1] 286188 0
Individual
Name [1] 286188 0
Deborah Viviane Ferrari
Address [1] 286188 0
Al Octavio Pinheiro Brisola, 9-75, Vila Universitaria, CEP: 17012-901
Country [1] 286188 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289421 0
Comite de Etica em Pesquisa da Faculdade de Odontologia de Bauru
Ethics committee address [1] 289421 0
Ethics committee country [1] 289421 0
Brazil
Date submitted for ethics approval [1] 289421 0
26/08/2009
Approval date [1] 289421 0
30/09/2009
Ethics approval number [1] 289421 0
145/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40726 0
Miss Patricia Danieli Campos
Address 40726 0
University of Sao Paulo
Al Octavio Pinheiro Brisola, 9-75, Vila Universitaria, CEP: 17012-901
Country 40726 0
Brazil
Phone 40726 0
55-14-32358458
Fax 40726 0
Email 40726 0
[email protected]
Contact person for public queries
Name 40727 0
Patricia Danieli Campos
Address 40727 0
University of Sao Paulo
Al Octavio Pinheiro Brisola, 9-75, Vila Universitaria, CEP: 17012-901
Country 40727 0
Brazil
Phone 40727 0
55-14-32358458
Fax 40727 0
Email 40727 0
[email protected]
Contact person for scientific queries
Name 40728 0
Patricia Danieli Campos
Address 40728 0
University of Sao Paulo
Al Octavio Pinheiro Brisola, 9-75, Vila Universitaria, CEP: 17012-901
Country 40728 0
Brazil
Phone 40728 0
55-14-32358458
Fax 40728 0
Email 40728 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.