Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss
|ClinicalTrials.gov Identifier: NCT02264314|
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Behavioral: Active Communication Education Program Other: Control||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- Adherence to the hearing aid [ Time Frame: at 12 months ]
- Quality of life [ Time Frame: at 12 months ]