Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000208808
Ethics application status
Approved
Date submitted
27/01/2012
Date registered
20/02/2012
Date last updated
20/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Teleaudiology: evaluation of teleconsultation efficacy for hearing aid fittings
Scientific title
Teleaudiology: evaluation of teleconsultation efficacy for hearing aid fittings
Secondary ID [1] 279803 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Teleaudiology for hearing aid fitting 285684 0
Condition category
Condition code
Ear 285872 285872 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study was to evaluate teleconsultation´s efficacy for hearing aid (HA) fittings. 50 hearing impaired individuals with age ranging from 39 to 88 years and ISO mean of audiometric thresholds between 30 and 68,7 dBHL participated in this study. The participants were divided in two groups by means of randomized stratification: control group or active group (n=25), submitted to face to face procedures and experimental or intervention group(n=25), submitted to synchronous teleconsultation with interactive video and remote application control. Following the consultations, an evaluator, blinded regarding the groups, performed the Hearing in Noise Test (HINT-Brazil). Nearly a month following the consultations, this evaluator analyzed the daily time of HA use (datalogging) and administered the International Outcome Inventory for Hearing Aids (IOI-HA). In order to evaluate the teleconsultation’s efficacy, the following elements were analyzed and compared to face to face procedures:
- the time for hearing aid programming, for real ear measurements and for the orientation
- the total time of the face to face and teleconsultation’s procedures
- the results of real ear measurements
- the HINT results
- the IOI-HA results
- the datalogging analyses
The difference between the face to face and the teleconsultation procedures was that in the second one, the procedures for hearing aid programming, real ear measurements and orientation were conducted by means the remote control of the devices. The Polycom PVX version 8.0.2 software was used to make the remote control and for the videoconferencing. The audiologist whit experience in the procedures for hearing aid fitting was 300 meters away from the test environment. The procedures were facilitated by a graduate student or professional without experience in the hearing aid fitting. The facilitator followed the procedures and informed the audiologist about problems that could happen during the teleconsultation.
Just after the face to face and teleconsultation procedures, an evaluator, blinded regarging to the procedures, carried out the HINT test. After a month of the procedures, the blinded evaluator asses the IOI-HA questionnaire and the hearing aid’s datalogging.
It was just one session for one hour and a half for both groups.
Intervention code [1] 284129 0
Rehabilitation
Comparator / control treatment
Active control - control group (n=25), submitted to face to face procedures
Control group
Active

Outcomes
Primary outcome [1] 286371 0
Teleconsultations have similar outcomes when are compared with the face to face consultations in audiology. In this study, the duration of each procedure (hearing aid programming, real ear measures and couseling about hearing aid management) and the overall time, the real ear measures, the spech perception results, the questionnaire results were compared in the control group and the intervention group.
Timepoint [1] 286371 0
The first consultation was performed just after randomization and included the hearing aid programming, real ear measures, counseling about hearing aid management and the speech perception assessment. After a month, the datalogging was analized and the IOI-HA (international Outcome Inventory for Hearing Aids) was applied.
Secondary outcome [1] 295703 0
The control group and the experimental group are similar when compared the time to the consultations, the Real Ear Measures results, the Hearing In Noise Test results, the datalogging analysis and the International Outcome Inventory for Hearing Aids.
Timepoint [1] 295703 0
Just after randomization and one month after the consultation

Eligibility
Key inclusion criteria
Hearing impaired individuals with indication for hearing aids. Sensorioneural hearing loss without previous experience with the hearing aids
Minimum age
39 Years
Maximum age
88 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with normal hearing or conductive hearing loss. Children.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects are randomically allocated in the control group or the experimental group. A person who doesn't know about the participant condition drawn the subject for the control or intervention group by mean numered papers in a opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects were drawn for the control group or the experimental group. Numbered papers were used for the randomisation process. For each person with sensorioneural hearing loss, a numbered paper was taken and the participant was assigned for the intervention or control group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4087 0
Brazil
State/province [1] 4087 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 284580 0
Self funded/Unfunded
Name [1] 284580 0
Patricia Danieli Campos
Country [1] 284580 0
Brazil
Primary sponsor type
Individual
Name
Patricia Danieli Campos
Address
Prudente de Moraes St, 8-54, Vila Falcao, CEP: 17051-010
Country
Brazil
Secondary sponsor category [1] 283497 0
Individual
Name [1] 283497 0
Deborah Viviane Ferrari
Address [1] 283497 0
Al Octavio Pinheiro Brisola, 9-75, Vila Universitaria, CEP: 17012-901
Country [1] 283497 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286567 0
Comite de Etica em Pesquisa da Faculdade de Odontologia de Bauru
Ethics committee address [1] 286567 0
Ethics committee country [1] 286567 0
Brazil
Date submitted for ethics approval [1] 286567 0
11/09/2009
Approval date [1] 286567 0
30/09/2009
Ethics approval number [1] 286567 0
144/2009

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

Contacts
Principal investigator
Name 33688 0
Address 33688 0
Country 33688 0
Phone 33688 0
Fax 33688 0
Email 33688 0
Contact person for public queries
Name 16935 0
Patricia Danieli Campos
Address 16935 0
Rua Prudente de Moraes, 8-54, Vila Falcao, Bauru - SP, CEP: 17051-010
Country 16935 0
Brazil
Phone 16935 0
55-14-32242922
Fax 16935 0
Email 16935 0
[email protected]
Contact person for scientific queries
Name 7863 0
Patricia Danieli Campos
Address 7863 0
Rua Prudente de Moraes, 8-54, Vila Falcao, Bauru - SP, CEP: 17051-010
Country 7863 0
Brazil
Phone 7863 0
55-14-32242922
Fax 7863 0
Email 7863 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.