Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss

January 11, 2017 updated by: Felipe Cardemil, University of Chile

Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial

Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. However, there are reports of adherence to the use of hearing aids of only to 40%. The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids. A randomized controlled trial was performed. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Hearing loss is the third most common chronic condition in over 65 years people, it is estimated that 77.8% of older adults suffer from it. Delivery of hearing aids to older adults with bilateral hearing loss is included in the Garantías Explícitas en Salud (GES) Guidelines of Chile. However, there are reports of adherence to the use of hearing aids of only to 40%. The GES guideline establishes the conducting of programs in audiological rehabilitation counseling, but there is no evidence that this is being developed in Chile.

Objective: The objective of this project is to measure the effectiveness of a tele-educative intervention to improve adherence to the use of hearing aids.

Material and Methods: A randomized controlled trial was performed. Demographic and audiometric variables were recorded. The active branch consists of the implementation of an educational program called Active Communication Education, consisting of 4 sessions with a trained rehabilitator. Participants will be also monitored by telephone headset use by personnel trained for three months. The control arm will consist of the usual care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after randomization. The primary outcome will assess adherence to the use of hearing aids. Secondarily related quality of life was assessed with hearing loss.

Analysis Plan: Data will be analyzed mediantes bivariate tests, student t for normally distributed continuous variables, and Fisher exact test for categorical variables. A model of multilevel mixed effects will be drawn considering the repeated measurements of outcomes assessed. For all analysis is considered an alpha=5%.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hearing loss worst than 40 db in the better ear
  • 65 years old or more

Exclusion Criteria:

  • Dementia
  • Prior surgery for hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This group received an audiological rehabilitation program with a tele-educative intervention boost
Behavioral: Active Communication Education Program
A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss
Other Names:
  • ACE Program
Placebo Comparator: Control
This group received no intervention
Other: Control
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.
Other Names:
  • Regular assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to the hearing aid
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UChile

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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