Assessment of the ACE Program for Rehabilitation in Hearing Loss

NCT01846676 | Completed DMC

• 1 other identifier: 221-2010
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Hearing loss, rehabilitation programs, adherence to hearing aids.

Outcome Measures

Primary Outcomes (1)

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

  One year

Study Arms (2)

Program counseling

ACTIVE COMPARATOR

Active branch, subject to the rehabilitation program

Behavioral: Active Communication Education Program

No counseling

PLACEBO COMPARATOR

Passive branch, which was control, with usual management (no intervention).

Other: Control

Interventions

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.

Program counseling

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.

No counseling

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Barros Luco Trudeau Hospital

San Miguel, Santiago, Santiago Metropolitan, 8900085, Chile

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Felipe Cardemil, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngology department, University of Chile

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

CL (1)