Clinical trial NCT02264314: Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss
Official title: Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Aged
Hearing Aids
Rehabilitation
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2014-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility 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

Primary outcomes:
measure: Adherence to the hearing aid
timeFrame: at 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: at 12 months
Other outcomes:
Locations:
Study officials:
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