Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12610000424000
Ethics application status
Approved
Date submitted
24/05/2010
Date registered
26/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Satisfaction of hearing aids users, with severe to profound hearing loss
Scientific title
Satisfaction of hearing aids users, with severe to profound hearing loss
Secondary ID [1] 251844 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing loss 257441 0
Condition category
Condition code
Ear 257590 257590 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
56 individuals, with ages ranging from 18 to 86 years-old, with severe and profound hearing loss, from a granted program of hearing aids were submitted to the Satisfaction with Amplification in Daily Life questionnaire. The study was conducted between May and August 2009. The researchers readed the questions aloud and registered the responses to the instrument used, to minimize the difficulties related to hearing loss on understanding the questions - it lasted about five minutes. From these responses, were calculated the global mean, subscale and questions means. The emphasis was to the questions that results in the highest and lowest averages.
Intervention code [1] 256539 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258508 0
To verify if the users believed that the hearing aid minimized their difficulties and if it helped them to understand the speech.
Timepoint [1] 258508 0
3 or more months after the hearing aids fitting
Secondary outcome [1] 264309 0
To verify if they feel more confident and able with the use of amplification and what's the problems with the use of amplification.
Timepoint [1] 264309 0
3 or more months after the hearing aids fitting

Eligibility
Key inclusion criteria
individuals with age superior to 18 years-old, with severe and profound hearing loss on both ears, from a granted program of hearing, aids fitted, minimally, 3 months ago.
Minimum age
18 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
neurological problems, not using the hearing aids.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 2652 0
Brazil
State/province [1] 2652 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 257032 0
University
Name [1] 257032 0
Federal University of Santa Maria
Country [1] 257032 0
Brazil
Primary sponsor type
University
Name
Bolsa fundo de Incentivo a Extensao
Address
Federal University of Santa Maria
Camobi, Km 9 - Campi
Santa Maria - RS
CEP: 97105-900
Country
Brazil
Secondary sponsor category [1] 256288 0
None
Name [1] 256288 0
Address [1] 256288 0
Country [1] 256288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259047 0
Ethics Comitee of Federal University of Santa Maria
Ethics committee address [1] 259047 0
Roraima Avenue, 1000, 702
Santa Maria - RS
CEP: 97105-900
Ethics committee country [1] 259047 0
Brazil
Date submitted for ethics approval [1] 259047 0
05/12/2006
Approval date [1] 259047 0
05/12/2006
Ethics approval number [1] 259047 0
0138.0.243.246-06

Summary
Brief summary
Introdution: it’s necessary to analyze the effectiveness of hearing aid fitting, considering the amplification’s need and difficulty in communication. Purpose: To analyze the satisfaction of adults and elderly, hearing aid users, with severe and profound hearing loss, by a questionnaire and research the factors that can difficult the adaptation. Methods: 56 individuals, aged between 18 and 86 years-old, with severe and profound hearing loss, from a granted program of hearing aids were submitted to the Satisfaction with Amplification in Daily Life questionnaire. From these, were calculated global mean, subscale and questions means. The emphasis was to the questions that results in the highest and lowest averages. Results: the sample comprised by 58,9% women and 41,1% men, about 55% patients with severe hearing loss and 45% profound. 87,5% reported use the hearing aids by 8 daily hours or more. The users believe that the hearing aids were the best option to minimize their deficiency and that it help them on speech comprehension. They feel more confident and able using the amplification and refer good customer service by professionals. The performance on the phone was the encountered problem. Conclusions: the patients demonstrated high satisfaction level. The degree of hearing loss, as well as the incompatibility between phone and telecoil’s systems and the difficulty on phone’s position are factors that difficult the good performance on the phone. The severe and profound hearing loss collaborate that the hearing aids were an integral part of the day and essential on communication’s help to this population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31211 0
Address 31211 0
Country 31211 0
Phone 31211 0
Fax 31211 0
Email 31211 0
Contact person for public queries
Name 14458 0
Alexandre Hundertmarck Lessa
Address 14458 0
Conde de Porto Alegre, 961, ap. 801
Santa Maria - RS
CEP: 97105-900
Country 14458 0
Brazil
Phone 14458 0
+55 55 84329337
Fax 14458 0
Email 14458 0
alexandrehl@gmail.com
Contact person for scientific queries
Name 5386 0
Alexandre Hundertmarck Lessa
Address 5386 0
Conde de Porto Alegre, 961, ap. 801
Santa Maria - RS
CEP: 97105-900
Country 5386 0
Brazil
Phone 5386 0
+55 55 84329337
Fax 5386 0
Email 5386 0
alexandrehl@gmail.com

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.