<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/NCT02233361</url>
  </required_header>
  <id_info>
    <org_study_id>2013/2/0252</org_study_id>
    <nct_id>NCT02233361</nct_id>
  </id_info>
  <brief_title>Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users</brief_title>
  <official_title>Use of Hearing Aids. Development and Implementation of a Counselling Program for Hearing Aid Users.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lovisenberg Diakonale Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stiftelsen Helse og Rehabilitering</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lovisenberg Diakonale Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proportion of elderly people is expected to increase greatly within the next couple of&#xD;
      decades, resulting in a proportional increase in the need for hearing rehabilitation.&#xD;
      However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus,&#xD;
      a major challenge for audiological rehabilitation is facilitating the use of fitted hearing&#xD;
      aids.&#xD;
&#xD;
      This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up&#xD;
      appointment on hearing aid use, 2) to implement a specialized counselling program based on&#xD;
      MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use&#xD;
      with datalogging technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hearing impairment is one of the most common health issues among adults in Western countries.&#xD;
      Socioeconomic status and level of family support are known to influence help-seeking among&#xD;
      older hearing-impaired individuals. Although hearing loss can have significant adverse&#xD;
      effects on an individual's quality of life, these effects have been found to be reversible&#xD;
      through the use of hearing aids. Even short-time use has been found to improve the emotional&#xD;
      and social experience of hearing impaired subjects. Unfortunately, of the approximately 200&#xD;
      000 people who have been provided with hearing aids in Norway, it is estimated that as many&#xD;
      as 20-40% seldom or never use them. Lack of follow-up support and low motivation may explain&#xD;
      why hearing impaired people do not use their hearing aids, but few research studies have&#xD;
      addressed these issues.&#xD;
&#xD;
      The aim of this study is to evaluate two approaches for increasing hearing aid use, to obtain&#xD;
      objective estimates of actual hearing aid use, to identify factors barriers to regular use&#xD;
      and to study hearing aid use related to age and gender. The study will examine the extent to&#xD;
      which follow-up appointments motivate use of hearing aids among people with hearing loss. A&#xD;
      randomized controlled design will determine whether hearing aid users who are informed in&#xD;
      advance of a follow-up appointment have a different pattern of hearing aid use than a control&#xD;
      group that is not preinformed of the follow-up appointment. For decades, the use of hearing&#xD;
      aids has been estimated using questionnaires. In the present study, hearing aid use will be&#xD;
      objectively measured in hours pr.day using the hearing aid's datalogging. In addition, the&#xD;
      study will develop, implement and evaluate a specialized counseling program for hearing aid&#xD;
      users. Difficulties with and barriers to hearing aid use will be documented and analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of follow-up appointments on hearing aid use</measure>
    <time_frame>1 year</time_frame>
    <description>The counseling utilize Motivational Interviewing (MI) to promote hearing aid use. Datalogging will be used to assess changes in hearing aid use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hearing aid use measured with datalogging technology</measure>
    <time_frame>When signed for the hearing aid and six month later</time_frame>
    <description>The use of datalogging technology will strengthen the evaluation by providing an objective measure of hearing aid use. Real time use of hearing aids in hours per day will be assessed by connecting the instrument to the programming tool, Noah.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Factor Barriers to hearing aid use</measure>
    <time_frame>At the follow up appointment. Six month after the hearing aid was assigned for.</time_frame>
    <description>Difficulties with and barriers to hearing aid use will be documented and analyzed. Problems and barriers associated with hearing aid use will be recorded and categorized by the research team.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Presbyacusis</condition>
  <arm_group>
    <arm_group_label>Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will be informed in advance of a follow-up appointment six month after they have received their hearing aid. They will know that support will be given and time-use of the hearing aid will be checked out. Counseling on hearing aid use will be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Counselling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will not receive any information of a follow-up appointment. However, they will receive a notice on this after six month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling</intervention_name>
    <description>A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed in advance.</description>
    <arm_group_label>Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 + years old&#xD;
&#xD;
          -  Subjective and objective need for hearing aids.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not being able to communicate in Norwegian.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorunn Solheim, Ph.d.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lovisenberg Diakonale Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jorunn Solheim, Ph.d.</last_name>
    <phone>+47 23225429</phone>
    <email>jorunn.solheim@lds.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kari Kvaerner, Ph.d.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Lovisenberg Diakonale Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0456</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorunn Solheim, Ph.d.</last_name>
      <email>jorunn.solheim@lds.no</email>
    </contact>
    <contact_backup>
      <last_name>Kari Kvaerner, Ph.d.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Jorunn Solheim, Ph.d.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hearing rehabilitation</keyword>
  <keyword>Elderly</keyword>
  <keyword>Hearing aid use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbycusis</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/NCT02233361
org study id: 2013/2/0252
nct id: NCT02233361
lead sponsor: 
collaborator: 
has dmc: No
The proportion of elderly people is expected to increase greatly within the next couple of
      decades, resulting in a proportional increase in the need for hearing rehabilitation.
      However, studies suggest that as many as 40% of hearing aids are never or seldom used. Thus,
      a major challenge for audiological rehabilitation is facilitating the use of fitted hearing
      aids.

      This study has four objectives; 1) to evaluate the effect of advanced notice of a follow-up
      appointment on hearing aid use, 2) to implement a specialized counselling program based on
      MI, 3) to identify barriers to hearing aid use, and 4) to objectively assess hearing aid use
      with datalogging technology.
Hearing impairment is one of the most common health issues among adults in Western countries.
      Socioeconomic status and level of family support are known to influence help-seeking among
      older hearing-impaired individuals. Although hearing loss can have significant adverse
      effects on an individual's quality of life, these effects have been found to be reversible
      through the use of hearing aids. Even short-time use has been found to improve the emotional
      and social experience of hearing impaired subjects. Unfortunately, of the approximately 200
      000 people who have been provided with hearing aids in Norway, it is estimated that as many
      as 20-40% seldom or never use them. Lack of follow-up support and low motivation may explain
      why hearing impaired people do not use their hearing aids, but few research studies have
      addressed these issues.

      The aim of this study is to evaluate two approaches for increasing hearing aid use, to obtain
      objective estimates of actual hearing aid use, to identify factors barriers to regular use
      and to study hearing aid use related to age and gender. The study will examine the extent to
      which follow-up appointments motivate use of hearing aids among people with hearing loss. A
      randomized controlled design will determine whether hearing aid users who are informed in
      advance of a follow-up appointment have a different pattern of hearing aid use than a control
      group that is not preinformed of the follow-up appointment. For decades, the use of hearing
      aids has been estimated using questionnaires. In the present study, hearing aid use will be
      objectively measured in hours pr.day using the hearing aid's datalogging. In addition, the
      study will develop, implement and evaluate a specialized counseling program for hearing aid
      users. Difficulties with and barriers to hearing aid use will be documented and analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: The effect of follow-up appointments on hearing aid use
time frame: 1 year
description: The counseling utilize Motivational Interviewing (MI) to promote hearing aid use. Datalogging will be used to assess changes in hearing aid use.
measure: Hearing aid use measured with datalogging technology
time frame: When signed for the hearing aid and six month later
description: The use of datalogging technology will strengthen the evaluation by providing an objective measure of hearing aid use. Real time use of hearing aids in hours per day will be assessed by connecting the instrument to the programming tool, Noah.
measure: Factor Barriers to hearing aid use
time frame: At the follow up appointment. Six month after the hearing aid was assigned for.
description: Difficulties with and barriers to hearing aid use will be documented and analyzed. Problems and barriers associated with hearing aid use will be recorded and categorized by the research team.
arm group label: Counseling
arm group type: Experimental
description: The intervention group will be informed in advance of a follow-up appointment six month after they have received their hearing aid. They will know that support will be given and time-use of the hearing aid will be checked out. Counseling on hearing aid use will be given.
arm group label: Counselling
arm group type: No Intervention
description: The control group will not receive any information of a follow-up appointment. However, they will receive a notice on this after six month.
intervention type: Behavioral
intervention name: Counseling
description: A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed in advance.
arm group label: Counseling
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jorunn Solheim, Ph.d.
role: Principal Investigator
affiliation: Lovisenberg Diakonale Hospital
last name: Jorunn Solheim, Ph.d.
phone: +47 23225429
email: jorunn.solheim@lds.no
last name: Kari Kvaerner, Ph.d.
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Norway
responsible party type: Sponsor
mesh term: Presbycusis