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Completed

NCT Number: NCT01846676

Assessment of the ACE Program for Rehabilitation in Hearing Loss

* 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barros Luco Trudeau Hospital

San Miguel, Santiago, Santiago Metropolitan, 8900085, Chile

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Communication Education Program

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.

Control

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.

Primary outcomes

  1. Adherence to the use of hearing aids in elderly population with hearing loss

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Assessment of the "Active Communication Education" Program for Audiological Rehabilitation in Patients With Hearing Loss Users of Hearing Aids

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 3, 2013
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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