<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02264314</url>
  </required_header>
  <id_info>
    <org_study_id>UChile</org_study_id>
    <nct_id>NCT02264314</nct_id>
  </id_info>
  <brief_title>Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss</brief_title>
  <official_title>Tele-educative Program to Improve Adherence to the Use of Hearing Aids in Patients With Hearing Loss: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Comisión Nacional de Investigación Científica y Tecnológica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hearing loss is the third most common chronic condition in over 65 years people, it is&#xD;
      estimated that 77.8% of older adults suffer from it. However, there are reports of adherence&#xD;
      to the use of hearing aids of only to 40%. The objective of this project is to measure the&#xD;
      effectiveness of a tele-educative intervention to improve adherence to the use of hearing&#xD;
      aids. A randomized controlled trial was performed. The active branch consists of the&#xD;
      implementation of an educational program called Active Communication Education, consisting of&#xD;
      4 sessions with a trained rehabilitator. Participants will be also monitored by telephone&#xD;
      headset use by personnel trained for three months. The control arm will consist of the usual&#xD;
      care received by these patients. All participants will be assessed at home at 3, 6, 9, and 12&#xD;
      months after randomization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Hearing loss is the third most common chronic condition in over 65 years&#xD;
      people, it is estimated that 77.8% of older adults suffer from it. Delivery of hearing aids&#xD;
      to older adults with bilateral hearing loss is included in the Garantías Explícitas en Salud&#xD;
      (GES) Guidelines of Chile. However, there are reports of adherence to the use of hearing aids&#xD;
      of only to 40%. The GES guideline establishes the conducting of programs in audiological&#xD;
      rehabilitation counseling, but there is no evidence that this is being developed in Chile.&#xD;
&#xD;
      Objective: The objective of this project is to measure the effectiveness of a tele-educative&#xD;
      intervention to improve adherence to the use of hearing aids.&#xD;
&#xD;
      Material and Methods: A randomized controlled trial was performed. Demographic and&#xD;
      audiometric variables were recorded. The active branch consists of the implementation of an&#xD;
      educational program called Active Communication Education, consisting of 4 sessions with a&#xD;
      trained rehabilitator. Participants will be also monitored by telephone headset use by&#xD;
      personnel trained for three months. The control arm will consist of the usual care received&#xD;
      by these patients. All participants will be assessed at home at 3, 6, 9, and 12 months after&#xD;
      randomization. The primary outcome will assess adherence to the use of hearing aids.&#xD;
      Secondarily related quality of life was assessed with hearing loss.&#xD;
&#xD;
      Analysis Plan: Data will be analyzed mediantes bivariate tests, student t for normally&#xD;
      distributed continuous variables, and Fisher exact test for categorical variables. A model of&#xD;
      multilevel mixed effects will be drawn considering the repeated measurements of outcomes&#xD;
      assessed. For all analysis is considered an alpha=5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to the hearing aid</measure>
    <time_frame>at 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received an audiological rehabilitation program with a tele-educative intervention boost</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group received no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Communication Education Program</intervention_name>
    <description>A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>ACE Program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <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.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Regular assistance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hearing loss worst than 40 db in the better ear&#xD;
&#xD;
          -  65 years old or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Prior surgery for hearing loss&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Felipe Cardemil</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Hearing Aids</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02264314
org study id: UChile
nct id: NCT02264314
lead sponsor: 
collaborator: 
has dmc: No
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.
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%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence to the hearing aid
time frame: at 12 months
measure: Quality of life
time frame: at 12 months
arm group label: Intervention
arm group type: Experimental
description: This group received an audiological rehabilitation program with a tele-educative intervention boost
arm group label: Control
arm group type: Placebo Comparator
description: This group received no intervention
intervention type: Behavioral
intervention name: Active Communication Education Program
description: A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss
arm group label: Intervention
other name: ACE Program
intervention type: Other
intervention name: Control
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.
arm group label: Control
other name: Regular assistance
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Felipe Cardemil
investigator title: MD
mesh term: Hearing Loss
mesh term: Deafness