Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000179639
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
17/02/2014
Date last updated
17/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Listening in elderly: To verify the impact of the self-perception of hearing loss on the quality of life of the elderly using the The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Hearing Handicap Inventory for the Elderly (HHIE) and Tinnitus Handicap Inventory questionnaires
Scientific title
Listening in elderly: To verify the impact of the self-perception of hearing loss on the quality of life of the elderly using the The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Hearing Handicap Inventory for the Elderly (HHIE) and Tinnitus Handicap Inventory questionnaires
Secondary ID [1] 283786 0
Nil
Universal Trial Number (UTN)
U1111-1151-4755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sensorineural hearing loss 290764 0
Presbycusis 291031 0
Condition category
Condition code
Ear 291126 291126 0 0
Deafness
Other 291127 291127 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Verify the impact of the self-perception of hearing loss and tinnitus on the quality of life of the elderly with Tinnitus Handicap Inventory questionnaires and audiological exams with the EP-25 Interacoustic audiometry. Participants will need to complete the questionnaires and audiological exams once only. The participants completed all the required questionnaires and audiological evaluations/exams in one day. The duration required for participants to complete the required questionnaires and audiological exams is one hour. All the participants will complete all the required questionnaires and audiological exams in 12 months.
Intervention code [1] 288472 0
Not applicable
Comparator / control treatment
Not applicable - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291113 0
The primary outcome of this trial is that there is a correlation between changes in hearing the elderly and poor quality of life, which contributes to decreased socialization of this subject. To this end, sixty-six elderly without neurological, psychiatric and / or hearing / Vestibular disorders underwent audiologic evaluation using EP-25 Interacoustic audiometry, They also answered Questionnaires both SF-36 and HHIE and Tinnitus Handicap Inventory (THI). The survey was Conducted in only one day for each participant. All data collection will take place at 1-year period.
Timepoint [1] 291113 0
The tonal audiometry and the handicap and SF-36 and THI questionaries were performed on only one day for approximately one hour. The examinations of 66 patients, ie the complete sample was conducted during one year. This outcome will be assessed at 12 months from baseline.
Secondary outcome [1] 306015 0
There is a correlation between an increase in the perception of hearing loss and poor quality of life The total score of the questionnaires was observed.
Timepoint [1] 306015 0
Data analysis was performed at 6 months after all participants have completed the trial's questionnaires.
Secondary outcome [2] 306409 0
There is a correlation between an increase in the perception of tinnitus and poor quality of life The total score of the questionnaires was observed.
Timepoint [2] 306409 0
Data analysis was performed at 1 month after all participants have completed the trial's questionnaires.

Eligibility
Key inclusion criteria
Ages above 60 years; seek care at the audiology department of the university hospital of aracaju; complain of hearing disorders.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with Neurological, psychiatric and/or hearing/vestibular disorders will be excluded this study

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis
Data were tabulated and processed by microcomputer application PASW Statistics data editor, version 19.0. To a description of the data made use of tabular presentation of the mean, median, the standard deviations of percentages and frequencies.
The normality of the samples was observed using the Shapiro-Wilk test. Kruskal-Wallis for comparison between the elderly who complain of difficulty in understanding speech and those who did not report such a complaint were used. The bivariate correlation test was used to analyze the correlation between the scores of each questionnaire, and aspects of these questionnaires among themselves. The level of significance was set at 0.05 and the alpha value of 0.1 was accepted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/02/2011
Actual
21/02/2011
Date of last participant enrolment
Anticipated
20/02/2012
Actual
20/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 5685 0
Brazil
State/province [1] 5685 0
Sergipe

Funding & Sponsors
Funding source category [1] 288445 0
Self funded/Unfunded
Name [1] 288445 0
Aline Cabral de Oliveira Barreto
Country [1] 288445 0
Brazil
Primary sponsor type
Individual
Name
Aline Cabral de Oliveira Barreto
Address
Federal University of Sergipe
Street G, number 38, Aruana. Aracaju. Sergipe. ZIP CODE: 49039-282
Country
Brazil
Secondary sponsor category [1] 287148 0
Individual
Name [1] 287148 0
Liliane Desgualdo Pereira
Address [1] 287148 0
Federal University of Sergipe
Street G, number 38, Aruana. Aracaju. Sergipe. ZIP CODE: 49039-282
Country [1] 287148 0
Brazil
Other collaborator category [1] 277734 0
Individual
Name [1] 277734 0
Priscila Silva Passos
Address [1] 277734 0
Federal University of Sergipe
Street Aurea Costa, number 45. Augusto Franco, Farolandia.
ZIP CODE: 49030110 - Aracaju, Sergipe
Country [1] 277734 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290319 0
Committee on Ethics in Research of Federal University of Sergipe
Ethics committee address [1] 290319 0
Ethics committee country [1] 290319 0
Brazil
Date submitted for ethics approval [1] 290319 0
18/11/2010
Approval date [1] 290319 0
06/12/2010
Ethics approval number [1] 290319 0
0159.0.107.000-10

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

Contacts
Principal investigator
Name 45062 0
Dr Aline Cabral de Oliveira Barreto
Address 45062 0
Federal University of Sergipe
Street G, Number 38, Porto Sul, aruana, Aracaju, Sergipe. Zip Code: 49039-282.
Country 45062 0
Brazil
Phone 45062 0
+157999211700
Fax 45062 0
Email 45062 0
[email protected]
Contact person for public queries
Name 45063 0
Aline Cabral de Oliveira Barreto
Address 45063 0
Federal University of Sergipe. Street G, Number 38, Porto Sul, aruana, Aracaju, Sergipe. Zip Code: 49039-282.
Country 45063 0
Brazil
Phone 45063 0
+157999211700
Fax 45063 0
Email 45063 0
[email protected]
Contact person for scientific queries
Name 45064 0
Aline Cabral de Oliveira Barreto
Address 45064 0
Federal University of Sergipe
Street G, Number 38, Porto Sul, aruana, Aracaju, Sergipe. Zip Code: 49039-282.
Country 45064 0
Brazil
Phone 45064 0
+157999211700
Fax 45064 0
Email 45064 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.