<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/NCT03270592</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr 157-09</org_study_id>
    <nct_id>NCT03270592</nct_id>
  </id_info>
  <brief_title>Assessment of Service and Hearing Dogs</brief_title>
  <official_title>Assessment of Service and Hearing Dogs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health and Social Affairs, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For persons with impairments and certain illnesses the use of service dogs may have positive&#xD;
      effect. The effects of using these dogs to assist in every day life need to be studied&#xD;
      further.The aim of the study was to assess how health care consumption was effected by using&#xD;
      certified service dogs and to study the cost-effectiveness of having a certified service dog.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory before and after study with the aim to study how health care&#xD;
      consumption was effected by using certified service dogs and to study the cost-effectiveness&#xD;
      of having a certified service dog. Data was collected before the education of the dog started&#xD;
      and the follow-up was made three months after completion of the education. Data was collected&#xD;
      on Health care consumption and outcomes in terms Health related quality of life and Health&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2009</start_date>
  <completion_date type="Actual">July 2, 2014</completion_date>
  <primary_completion_date type="Actual">July 2, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total costs</measure>
    <time_frame>Three months follow-up</time_frame>
    <description>Health care costs, cost of informal care, municipal costs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life, EQ-5D</measure>
    <time_frame>Tree months follow-up</time_frame>
    <description>EQ-5D is a generic quality of life instrument including five dimensions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Life time perspective</time_frame>
    <description>Cost per quality adjusted life years (QALY)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life, RAND-36</measure>
    <time_frame>Three months follow-up</time_frame>
    <description>RAND-36 is a generic quality of life instrument including eight dimensions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO-5 wellbeing index</measure>
    <time_frame>Three months follow-up</time_frame>
    <description>WHO-5 wellbeing index is an index measuring wellbeing on five dimensions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rosenberg self-esteem scale</measure>
    <time_frame>Three month follow-up</time_frame>
    <description>Rosenberg self-esteem scale measures self esteem with ten questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-VAS</measure>
    <time_frame>Three months follow-up</time_frame>
    <description>EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Impairment</condition>
  <condition>Diabetes</condition>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Service dogs</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Service dog</intervention_name>
    <description>Use of a individualized certified service dog</description>
    <arm_group_label>Service dogs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 16 years&#xD;
&#xD;
          -  Having a regular companion dog&#xD;
&#xD;
          -  Being in need of a certified service dog (due to impairment, diabetes, epilepsy and&#xD;
             deafness)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars-Åke Levin, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Martina Lundqvist</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Service dogs</keyword>
  <keyword>Alert dogs</keyword>
  <keyword>Costs</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Cost-effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03270592
org study id: Dnr 157-09
nct id: NCT03270592
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For persons with impairments and certain illnesses the use of service dogs may have positive
      effect. The effects of using these dogs to assist in every day life need to be studied
      further.The aim of the study was to assess how health care consumption was effected by using
      certified service dogs and to study the cost-effectiveness of having a certified service dog.
This is an exploratory before and after study with the aim to study how health care
      consumption was effected by using certified service dogs and to study the cost-effectiveness
      of having a certified service dog. Data was collected before the education of the dog started
      and the follow-up was made three months after completion of the education. Data was collected
      on Health care consumption and outcomes in terms Health related quality of life and Health
      outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Total costs
time frame: Three months follow-up
description: Health care costs, cost of informal care, municipal costs
measure: Health related quality of life, EQ-5D
time frame: Tree months follow-up
description: EQ-5D is a generic quality of life instrument including five dimensions
measure: Cost-effectiveness
time frame: Life time perspective
description: Cost per quality adjusted life years (QALY)
measure: Health related quality of life, RAND-36
time frame: Three months follow-up
description: RAND-36 is a generic quality of life instrument including eight dimensions
measure: WHO-5 wellbeing index
time frame: Three months follow-up
description: WHO-5 wellbeing index is an index measuring wellbeing on five dimensions
measure: Rosenberg self-esteem scale
time frame: Three month follow-up
description: Rosenberg self-esteem scale measures self esteem with ten questions
measure: EQ-VAS
time frame: Three months follow-up
description: EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)
arm group label: Service dogs
arm group type: Other
description: Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog
intervention type: Other
intervention name: Service dog
description: Use of a individualized certified service dog
arm group label: Service dogs
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Lars-Åke Levin, Professor
role: Study Director
affiliation: Linkoeping University
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Martina Lundqvist
investigator title: Principal Investigator
mesh term: Epilepsy
sharing ipd: No