Assessment of the ACE Program for Rehabilitation in Hearing Loss

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Behavioral: Active Communication Education Program; Other: Control

• Registration Number: NCT01846676
• Lead Sponsor: University of Chile

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-03
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Program counseling	Active Communication Education Program	Active branch, subject to the rehabilitation program
No counseling	Control	Passive branch, which was control, with usual management (no intervention).

Primary Outcome Measures

Name	Time	Method
Adherence to the use of hearing aids in elderly population with hearing loss	One year

Trial Locations

Locations (1)

Barros Luco Trudeau Hospital; 🇨🇱 San Miguel, Santiago, Región Metropolitana, Chile