<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/NCT03015428</url>
  </required_header>
  <id_info>
    <org_study_id>LTWD1</org_study_id>
    <nct_id>NCT03015428</nct_id>
  </id_info>
  <brief_title>&quot;Living Together With Dementia&quot;_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar De São João, E.P.E.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Hospitalar De São João, E.P.E.</source>
  <brief_summary>
    <textblock>
      This study aims to experimentally evaluate the training program for family caregivers of&#xD;
      people with dementia_&quot;Living together with Dementia.&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will begin in March 2016, with the initial assessment of family caregivers of&#xD;
      people with dementia.&#xD;
&#xD;
      These were recruited through hospital neurology clinic and must comply with a set of&#xD;
      pre-established criteria.&#xD;
&#xD;
      It is expected a total of 20 participants in the study (10 in the experimental group and 10&#xD;
      in control group).&#xD;
&#xD;
      Interventions will take place over the months of March and April. The final evaluation is&#xD;
      scheduled for late April and the follow up to July 2016.&#xD;
&#xD;
      an evaluation document itself for this study was built.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Caregiver Overload Scale</measure>
    <time_frame>7 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Carers Assessment Satisfaction Index</measure>
    <time_frame>7 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Carers Assessment Difficulties Index</measure>
    <time_frame>7 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventions:&#xD;
Give information Teach and train strategies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>psychoeducation</intervention_name>
    <description>Providing knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme</description>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be primary caregiver of the person with dementia&#xD;
&#xD;
          -  Be able to read and write&#xD;
&#xD;
          -  Carers of peolpe with dementia in initial or moderate stage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The person with dementia have severe mental pathologies associated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lia Sousa, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Hospitalar De São João, E.P.E.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHSaoJoao</name>
      <address>
        <city>Oporto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>April 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 7, 2017</last_update_submitted>
  <last_update_submitted_qc>January 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Hospitalar De São João, E.P.E.</investigator_affiliation>
    <investigator_full_name>Lia Sousa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Family caregivers</keyword>
  <keyword>training programme</keyword>
  <keyword>dementia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT03015428
org study id: LTWD1
nct id: NCT03015428
lead sponsor: 
This study aims to experimentally evaluate the training program for family caregivers of
      people with dementia_"Living together with Dementia."
This study will begin in March 2016, with the initial assessment of family caregivers of
      people with dementia.

      These were recruited through hospital neurology clinic and must comply with a set of
      pre-established criteria.

      It is expected a total of 20 participants in the study (10 in the experimental group and 10
      in control group).

      Interventions will take place over the months of March and April. The final evaluation is
      scheduled for late April and the follow up to July 2016.

      an evaluation document itself for this study was built.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Caregiver Overload Scale
time frame: 7 weeks
measure: Carers Assessment Satisfaction Index
time frame: 7 weeks
measure: Carers Assessment Difficulties Index
time frame: 7 weeks
arm group label: Psychoeducation
arm group type: Experimental
description: Interventions:
Give information Teach and train strategies
intervention type: Other
intervention name: psychoeducation
description: Providing knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme
arm group label: Psychoeducation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lia Sousa, Master
role: Principal Investigator
affiliation: Centro Hospitalar De São João, E.P.E.
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Centro Hospitalar De São João, E.P.E.
investigator full name: Lia Sousa
investigator title: Principal Investigator
mesh term: Dementia