Clinical trial NCT01846676: Assessment of the ACE Program for Rehabilitation in Hearing Loss
Official title: Assessment of the "Active Communication Education" Program for Audiological Rehabilitation in Patients With Hearing Loss Users of Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing loss, rehabilitation programs, adherence to hearing aids.
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to the use of hearing aids in elderly population with hearing loss
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: San Miguel, Santiago
country: Chile
facility: Barros Luco Trudeau Hospital
state: Región Metropolitana
Study officials:
affiliation: University of Chile
name: Felipe Cardemil, MD
role: PRINCIPAL_INVESTIGATOR
References: