Assessment of the ACE Program for Rehabilitation in Hearing Loss

NCT ID: NCT01846676

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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* 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.

Detailed Description

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* 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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Program counseling

Active branch, subject to the rehabilitation program

Group Type ACTIVE_COMPARATOR

Active Communication Education Program

Intervention Type BEHAVIORAL

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.

No counseling

Passive branch, which was control, with usual management (no intervention).

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Felipe Cardemil

Otolaryngology department, University of Chile

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felipe Cardemil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

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Barros Luco Trudeau Hospital

San Miguel, Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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221-2010

Identifier Type: -

Identifier Source: org_study_id

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