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

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ClinicalTrials.gov Identifier: NCT02264314
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Felipe Cardemil, University of Chile

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: Active Communication Education Program Other: Control Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial
Study Start Date : July 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Regular assistance




Primary Outcome Measures :
  1. Adherence to the hearing aid [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: at 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Felipe Cardemil, MD, University of Chile
ClinicalTrials.gov Identifier: NCT02264314     History of Changes
Other Study ID Numbers: UChile
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by Felipe Cardemil, University of Chile:
Aged
Hearing Aids
Rehabilitation

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