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Assessment of the ACE Program for Rehabilitation in Hearing Loss

U

University of Chile

Status

Completed

Conditions

Hearing Loss

Treatments

Other: Control
Behavioral: Active Communication Education Program

Study type

Interventional

Funder types

Other

Identifiers

NCT01846676
221-2010

Details and patient eligibility

About

  • 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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

180 participants in 2 patient groups, including a placebo group

Program counseling
Active Comparator group
Description:
Active branch, subject to the rehabilitation program
Treatment:
Behavioral: Active Communication Education Program
No counseling
Placebo Comparator group
Description:
Passive branch, which was control, with usual management (no intervention).
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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