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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01846676
Other study ID # 221-2010
Secondary ID
Status Completed
Phase N/A
First received April 29, 2013
Last updated January 11, 2017
Start date October 2012
Est. completion date December 2013

Study information

Verified date January 2017
Source University of Chile
Contact n/a
Is FDA regulated No
Health authority Chile: Comité de Ética Científico
Study type Interventional

Clinical Trial Summary

- Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In 2007 there was designed a rehabilitation program called ACE, which aims to improve rehabilitation directed to hearing aids users. The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.

- Objective: To evaluate the utility of a standardized counselling program in patients with hearing loss.

- Material and Methods: A before/after trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older with hearing loss diagnosed by pure tone audiometry will be included. To assess adherence we will use the IOI-HA scale.


Description:

- Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In Chile, hearing aids are provided by the State for elderly population. In 2007 there was designed a rehabilitation program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.

- The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.

- Objective: To evaluate the utility of a standardized counseling program in patients with hearing loss.

- Material and Methods: A before/after clinical trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older diagnosed by pure tone audiometry who are beneficiaries of the Public GES hearing loss programme and receive a hearing aid will be included. The subjects will be randomized in two branches: Active branch, subject to the rehabilitation program; and passive branch, which was control, with usual management (no intervention). To assess adherence we will use the IOI-HA scale.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Bilateral hearing loss equal or higher than 40 decibels

- Age 65 years old or more

- Agree to be included in the study

- Have a relative to go to the intervention with the subject

Exclusion Criteria:

- Severe organic brain impairment

- Physical or mental incapacity to understand the study questionnaires

- Structural pathology of the ear that produces hearing loss as chronic otitis media, ear canal tumor, or tumor of the cerebellopontine angle

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Active Communication Education Program
The program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.
Other:
Control
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.

Locations

Country Name City State
Chile Barros Luco Trudeau Hospital San Miguel, Santiago Región Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to the use of hearing aids in elderly population with hearing loss One year No
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