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

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Other: Control; Behavioral: Active Communication Education Program

• Registration Number: NCT02264314
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2013-12
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-15
• Study Completion: 2014-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	This group received no intervention
Intervention	Active Communication Education Program	This group received an audiological rehabilitation program with a tele-educative intervention boost

Primary Outcome Measures

Name	Time	Method
Adherence to the hearing aid	at 12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	at 12 months