Clinical Trial to Assess the ACE Program for Rehabilitation in Hearing Loss

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Felipe Cardemil, University of Chile
ClinicalTrials.gov Identifier:
NCT01846676
First received: April 29, 2013
Last updated: May 29, 2013
Last verified: May 2013
  Purpose
  • 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.

Condition Intervention
Hearing Loss
Behavioral: Active Communication Education Program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial to Assess the Active Communication Education Program for Rehabilitation in Patients With Hearing Loss Users of Hearing Aids

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • Adherence to the use of hearing aids in elderly population with hearing loss [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Program counseling
Active branch, subject to the rehabilitation program
Behavioral: 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.
Placebo Comparator: No counseling
Passive branch, which was control, with usual management (no intervention).

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846676

Locations
Chile
Barros Luco Trudeau Hospital
San Miguel, Santiago, Región Metropolitana, Chile, 8900085
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: Felipe Cardemil, MD University of Chile
  More Information

No publications provided

Responsible Party: Felipe Cardemil, Otolaryngology department, University of Chile, University of Chile
ClinicalTrials.gov Identifier: NCT01846676     History of Changes
Other Study ID Numbers: 221-2010
Study First Received: April 29, 2013
Last Updated: May 29, 2013
Health Authority: Chile: Comité de Ética Científico

Keywords provided by University of Chile:
Hearing loss, rehabilitation programs, adherence to hearing aids.

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014