Hearing LossNCT01017419
Orientation for Hearing Aid Users: Information Retention
An observational study of Hearing Loss, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2004to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types.
Who may be able to join
- older than 18 years old
- sensorineural hearing loss, hearing aid candidate
Who cannot join
- severe dexterity or visual problems. Cognitive or memory disorders
Trial locations and contacts
1 site in 1 country.
About this study
Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this
Read the detailed description
Introduction: The understanding and retention of orientations provided by the health professional increases patient's satisfaction and compliance to treatment and reduces treatment duration and costs. Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this. Methods: Participated in this study 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types. Orientations were offered at the time of diagnosis and hearing aid fitting. At the first follow up visit patients were interviewed regarding their hearing loss' characteristics as well as hearing aid care and use (probed recall task). It was also evaluated how participants manipulated their devices. A protocol was used to score participant's responses. Results: on average participants could retain 31,6% and 83,6% of the orientation provided regarding their hearing loss and hearing aid care and use. There was a negative correlation between age and amount of information retained. There was no influence of degree of hearing loss, academic and socio-economic statues. Conclusion: The hearing impaired patients have difficulty to recall orientation provided therefore the use of facilitation strategies to information retained is necessary.
- Conditions
- Hearing Loss
- Being tested
- Counseling
- Keywords
- hearing aids, counseling
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Informational Counseling provided after hearing aid fitting
| Study group | Role | What they receive |
|---|---|---|
| Audiology counseling | Not described Receives: Behavioral: Counseling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startMar 2004
- Primary completionJan 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Deborah V Ferrari, Doctor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017419
- Sponsor's protocol ID
- 3
- Status last verified
- Nov 2009
- First submitted
- 19 Nov 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orientation for Hearing Aid Users: Information Retention
- ClinicalTrials.gov ID
- NCT01017419
- Acronym / sponsor ID
- 3
- Conditions
- Hearing Loss
- Keywords
- hearing aids, counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this
Detailed description
Introduction: The understanding and retention of orientations provided by the health professional increases patient's satisfaction and compliance to treatment and reduces treatment duration and costs. Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this. Methods: Participated in this study 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types. Orientations were offered at the time of diagnosis and hearing aid fitting. At the first follow up visit patients were interviewed regarding their hearing loss' characteristics as well as hearing aid care and use (probed recall task). It was also evaluated how participants manipulated their devices. A protocol was used to score participant's responses. Results: on average participants could retain 31,6% and 83,6% of the orientation provided regarding their hearing loss and hearing aid care and use. There was a negative correlation between age and amount of information retained. There was no influence of degree of hearing loss, academic and socio-economic statues. Conclusion: The hearing impaired patients have difficulty to recall orientation provided therefore the use of facilitation strategies to information retained is necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Audiology counseling | – | Behavioral: Counseling |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types.
Key inclusion criteria (2 listed)
- older than 18 years old
- sensorineural hearing loss, hearing aid candidate
Key exclusion criteria (1 listed)
- severe dexterity or visual problems. Cognitive or memory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingInformational Counseling provided after hearing aid fitting | Behavioural | Audiology counseling |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah V Ferrari, Doctor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.