Hearing LossNCT02264314
Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss
A study testing Active Communication Education Program in people with Hearing Loss, run by University of Chile.
Trial summary
Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. However, there are reports of adherence to the use of hearing aids of only to 40%. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Active Communication Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2014
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hearing loss worst than 40 db in the better ear
- 65 years old or more
Who cannot join
- Dementia
- Prior surgery for hearing loss
About this study
Official title: Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial
Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. However, there are reports of adherence to the use of hearing aids of only to 40%. The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids. A randomized controlled trial was performed. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization.
Read the detailed description
Introduction: Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. Delivery of hearing aids to older adults with bilateral hearing loss is included in the Garantías Explícitas en Salud (GES) Guidelines of Chile. However, there are reports of adherence to the use of hearing aids of only to 40%. The GES guideline establishes the conducting of programs in audiological rehabilitation counseling, but there is no evidence that this is being developed in Chile.
Objective: The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids.
Material and Methods: A randomized controlled trial was performed. Demographic and audiometric variables were recorded. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization. The primary outcome will assess adherence to the use of hearing aids. Secondarily related quality of life was assessed with hearing loss.
Analysis Plan: Data will be analyzed mediantes bivariate tests, student t for normally distributed continuous variables, and Fisher exact test for categorical variables. A model of multilevel mixed effects will be drawn considering the repeated measurements of outcomes assessed. For all analysis is considered an alpha=5%.
- Conditions
- Hearing Loss
- Being tested
- Active Communication Education Program, Control
- Keywords
- Aged, Hearing Aids, Rehabilitation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Communication Education ProgramBehavioural
Also called ACE Program
A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss
ControlOther
Also called Regular assistance
Participants in this arm will not receive intervention during the study protocol time. After the completion of the protocol, they will receive the same intervention that the intervention group, meaning the ACE program intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group received an audiological rehabilitation program with a tele-educative intervention boost Receives: Behavioral: Active Communication Education Program |
| Control | Placebo comparator | This group received no intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the hearing aid
Measured: at 12 months
Secondary outcomes (1)
Quality of life
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2014
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Felipe Cardemil, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264314
- Sponsor's protocol ID
- UChile
- Status last verified
- Jan 2017
- First submitted
- 8 Oct 2014
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02264314
- Acronym / sponsor ID
- UChile
- Conditions
- Hearing Loss
- Keywords
- Aged, Hearing Aids, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Oct 2014 (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.
Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. However, there are reports of adherence to the use of hearing aids of only to 40%. The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids. A randomized controlled trial was performed. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization.
Detailed description
Introduction: Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. Delivery of hearing aids to older adults with bilateral hearing loss is included in the Garantías Explícitas en Salud (GES) Guidelines of Chile. However, there are reports of adherence to the use of hearing aids of only to 40%. The GES guideline establishes the conducting of programs in audiological rehabilitation counseling, but there is no evidence that this is being developed in Chile.
Objective: The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids.
Material and Methods: A randomized controlled trial was performed. Demographic and audiometric variables were recorded. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization. The primary outcome will assess adherence to the use of hearing aids. Secondarily related quality of life was assessed with hearing loss.
Analysis Plan: Data will be analyzed mediantes bivariate tests, student t for normally distributed continuous variables, and Fisher exact test for categorical variables. A model of multilevel mixed effects will be drawn considering the repeated measurements of outcomes assessed. For all analysis is considered an alpha=5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Active Communication Education ProgramThis group received an audiological rehabilitation program with a tele-educative intervention boost |
| Control | Placebo comparator | Other: ControlThis group received no intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Hearing loss worst than 40 db in the better ear
- 65 years old or more
Key exclusion criteria (2 listed)
- Dementia
- Prior surgery for hearing loss
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 |
|---|---|---|
| Active Communication Education ProgramAlso: ACE ProgramA behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss | Behavioural | Intervention |
| ControlAlso: Regular assistanceParticipants in this arm will not receive intervention during the study protocol time. After the completion of the protocol, they will receive the same intervention that the intervention group, meaning the ACE program intervention. | Other | Control |
Primary outcome
Adherence to the hearing aid
Time frame: at 12 months
1 secondary outcome
Quality of life
Time frame: at 12 months
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 13 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Active Communication Education Program in people with Hearing Loss, run by University of Chile.
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 2 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Adherence to the hearing aid (time frame: at 12 months). It is what the study was designed to measure, not a finding.
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 13 Jan 2017.