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Assessment of the ACE Program for Rehabilitation in Hearing Loss

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Active Communication Education Program
Control
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing loss, rehabilitation programs, adherence to hearing aids.

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Barros Luco Trudeau Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Program counseling

No counseling

Arm Description

Active branch, subject to the rehabilitation program

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 29, 2013
Last Updated
January 11, 2017
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT01846676
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing loss, rehabilitation programs, adherence to hearing aids.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Program counseling
Arm Type
Active Comparator
Arm Description
Active branch, subject to the rehabilitation program
Arm Title
No counseling
Arm Type
Placebo Comparator
Arm Description
Passive branch, which was control, with usual management (no intervention).
Intervention Type
Behavioral
Intervention Name(s)
Active Communication Education Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
Adherence to the use of hearing aids in elderly population with hearing loss
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Cardemil, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barros Luco Trudeau Hospital
City
San Miguel, Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8900085
Country
Chile

12. IPD Sharing Statement

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Assessment of the ACE Program for Rehabilitation in Hearing Loss

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