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

NCT02264314 | Completed

• 1 other identifier: UChile
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hearing Loss

Keywords

Aged; Hearing Aids; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adherence to the hearing aid

  at 12 months

Secondary Outcomes (1)

• Quality of life

  at 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

This group received an audiological rehabilitation program with a tele-educative intervention boost

Behavioral: Active Communication Education Program

Control

PLACEBO COMPARATOR

This group received no intervention

Other: Control

Interventions

Active Communication Education Program BEHAVIORAL

A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss

Also known as: ACE Program

Intervention

Control OTHER

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.

Also known as: Regular assistance

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dementia
• Prior surgery for hearing loss

Sponsors & Collaborators

• University of Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 15, 2014
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 13, 2017

Record last verified: 2017-01