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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active Communication Education Program
Control
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Aged, Hearing Aids, Rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

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

    This group received no intervention

    Outcomes

    Primary Outcome Measures

    Adherence to the hearing aid

    Secondary Outcome Measures

    Quality of life

    Full Information

    First Posted
    October 8, 2014
    Last Updated
    January 11, 2017
    Sponsor
    University of Chile
    Collaborators
    Comisión Nacional de Investigación Científica y Tecnológica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02264314
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Chile
    Collaborators
    Comisión Nacional de Investigación Científica y Tecnológica

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss
    Keywords
    Aged, Hearing Aids, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    This group received an audiological rehabilitation program with a tele-educative intervention boost
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    This group received no intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Communication Education Program
    Other Intervention Name(s)
    ACE Program
    Intervention Description
    A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Other Intervention Name(s)
    Regular assistance
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Adherence to the hearing aid
    Time Frame
    at 12 months
    Secondary Outcome Measure Information:
    Title
    Quality of life
    Time Frame
    at 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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