<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/NCT03260608</url>
  </required_header>
  <id_info>
    <org_study_id>17-0326</org_study_id>
    <nct_id>NCT03260608</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Psychoeducation and Support Protocol by Phone in the Aid of Caregivers of Patients With Dementia.</brief_title>
  <official_title>Randomized Clinical Assessment to Evaluate the Effectiveness of a Psychoeducation and Support Protocol by Telephone, in the Aid of Caregivers of Patients With Dementia in Specialized Ambulatory Accompanying</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Dementias are neurodegenerative syndromes typical of the elderly population and causing a&#xD;
      high degree of disability and sick of dependence on others for care. Caregivers of patients&#xD;
      with dementia, especially those belonging to the same family suffer with high overhead and is&#xD;
      often affected by losses in their own health. The aim of this study is to evaluate the&#xD;
      efficacy of a psychoeducation and protocol support, conducted by telephone, in aid of&#xD;
      patients with dementia caregivers in specialized outpatient treatment. It will be selected&#xD;
      patients in outpatient specialized care. The primary outcome is the change in Zarit Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dementias are neurodegenerative syndromes typical of the elderly population and cause a high&#xD;
      degree of incapacity and dependence of the patient in relation to the care of others.&#xD;
      Caregivers of patients with dementia, especially those belonging to the same family, suffer&#xD;
      from a high degree of overload, and are often affected by impairments in their own health.&#xD;
      Previous studies have shown that telephone interventions for the assistance and guidance of&#xD;
      these individuals have a positive impact on their own quality of life as well as on the&#xD;
      family members under their care. Measures like this can also optimize specialized services&#xD;
      and facilitate the search for medical help when needed.&#xD;
&#xD;
      In this way, the present study aims to evaluate the efficacy of a psychoeducation and support&#xD;
      protocol, performed by telephone, to assist caregivers of patients with dementia under&#xD;
      specialized outpatient follow-up.&#xD;
&#xD;
      Patients will be divided into two groups. Participants in the intervention group, in addition&#xD;
      to the usual primary health care, will receive weekly telephone contacts over a period of&#xD;
      eight weeks, previously scheduled with psychoeducational guidelines and support in the&#xD;
      management of their relatives and with dementia. The control group will receive the usual&#xD;
      follow-up at the in primary health care. Both group will received a prited materials about&#xD;
      problematic behavior.&#xD;
&#xD;
      Considering the prevalence and impact of dementia syndromes, it is necessary to conduct&#xD;
      studies that are directed at reducing the burden and promoting the information and care of&#xD;
      the caregivers of patients with dementia, also providing an improvement in the quality of&#xD;
      care. The present project brings as scientific contribution an innovative approach to the&#xD;
      reality of our country, with great potential to become an alternative, cost-effective and&#xD;
      easily accessible measure for the assistance of people with dementia and their relatives and&#xD;
      caregivers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Anticipated">June 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2020</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>
    <intervention_model_description>We will select 148 caregivers. Patients will be divided into two groups, both groups will receive printed materials about problematics behaviors in dementia.&#xD;
Participants in the intervention group will receive weekly telephone contacts over a period of eight weeks, previously scheduled with psychoeducational and support in the management of their relatives with dementia. Caregivers in the intervention group will have access to a number of phones to spontaneously contact specific guidelines during the eight weeks of intervention.&#xD;
Patients from both groups will be interviewed in the baseline, at 8 weeks and 16 weeks.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The individual who evaluates the outcome(s) of interest in this case the applicators of scales and questionnaires</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the caregiver's level of burden</measure>
    <time_frame>Week 9</time_frame>
    <description>Zarit Burden Interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in the caregiver's level of burden</measure>
    <time_frame>Week 18</time_frame>
    <description>Zarit Burden Interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the caregivers's depressive symptoms</measure>
    <time_frame>Week 9</time_frame>
    <description>Beck Depression Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the caregivers's depressive symptoms</measure>
    <time_frame>Week 18</time_frame>
    <description>Beck Depression Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the caregivers's anxiety symptoms</measure>
    <time_frame>Week 9</time_frame>
    <description>Beck Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the caregivers's anxiety symptoms</measure>
    <time_frame>Week 18</time_frame>
    <description>Beck Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the caregivers's quality of life</measure>
    <time_frame>Week 9</time_frame>
    <description>Quality of Life Questionnaire - WHOQOL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the caregivers's quality of life</measure>
    <time_frame>Week 18</time_frame>
    <description>Quality of Life Questionnaire - WHOQOL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient</measure>
    <time_frame>Week 9</time_frame>
    <description>Neuropsychiatric Inventory - NPI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient</measure>
    <time_frame>Week 18</time_frame>
    <description>Neuropsychiatric Inventory - NPI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the patient functionality</measure>
    <time_frame>Week 9</time_frame>
    <description>Pfeffer Functional Activities Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the patient functionality</measure>
    <time_frame>Week 18</time_frame>
    <description>Pfeffer Functional Activities Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">148</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telesupport: eight weekly phone calls of psychoeducation and support on the illness of their relatives. Patients will also receive printed materials on problematic behaviors about dementia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telesupport</intervention_name>
    <description>In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  home caregivers&#xD;
&#xD;
          -  female and of the same family as the patient&#xD;
&#xD;
          -  dementia of any etiology and severity&#xD;
&#xD;
          -  caregivers should be responsible for the patient for at least 40 hours per week and&#xD;
             for a -minimum period of 6 months&#xD;
&#xD;
          -  must have at least 4 years of formal study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  caregivers with physical limitations that prevent the application of research&#xD;
             instruments&#xD;
&#xD;
          -  patients with significant functional impairment related to other diseases&#xD;
&#xD;
          -  plans by the caregiver to place the patient in a long-term home in the next 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female caregivers</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Artur S Schuh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Artur S Schuh, PhD</last_name>
    <phone>33598520</phone>
    <email>schuh.afs@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andressa H Hermes-Pereira, CP</last_name>
    <phone>33598520</phone>
    <email>andressahpereira@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andressa H Pereira, CP</last_name>
      <phone>5551997957558</phone>
      <email>andressahpereira@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dementia, deficits, burden, caregivers, telemedicine.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03260608
org study id: 17-0326
nct id: NCT03260608
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dementias are neurodegenerative syndromes typical of the elderly population and causing a
      high degree of disability and sick of dependence on others for care. Caregivers of patients
      with dementia, especially those belonging to the same family suffer with high overhead and is
      often affected by losses in their own health. The aim of this study is to evaluate the
      efficacy of a psychoeducation and protocol support, conducted by telephone, in aid of
      patients with dementia caregivers in specialized outpatient treatment. It will be selected
      patients in outpatient specialized care. The primary outcome is the change in Zarit Scale.
Dementias are neurodegenerative syndromes typical of the elderly population and cause a high
      degree of incapacity and dependence of the patient in relation to the care of others.
      Caregivers of patients with dementia, especially those belonging to the same family, suffer
      from a high degree of overload, and are often affected by impairments in their own health.
      Previous studies have shown that telephone interventions for the assistance and guidance of
      these individuals have a positive impact on their own quality of life as well as on the
      family members under their care. Measures like this can also optimize specialized services
      and facilitate the search for medical help when needed.

      In this way, the present study aims to evaluate the efficacy of a psychoeducation and support
      protocol, performed by telephone, to assist caregivers of patients with dementia under
      specialized outpatient follow-up.

      Patients will be divided into two groups. Participants in the intervention group, in addition
      to the usual primary health care, will receive weekly telephone contacts over a period of
      eight weeks, previously scheduled with psychoeducational guidelines and support in the
      management of their relatives and with dementia. The control group will receive the usual
      follow-up at the in primary health care. Both group will received a prited materials about
      problematic behavior.

      Considering the prevalence and impact of dementia syndromes, it is necessary to conduct
      studies that are directed at reducing the burden and promoting the information and care of
      the caregivers of patients with dementia, also providing an improvement in the quality of
      care. The present project brings as scientific contribution an innovative approach to the
      reality of our country, with great potential to become an alternative, cost-effective and
      easily accessible measure for the assistance of people with dementia and their relatives and
      caregivers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will select 148 caregivers. Patients will be divided into two groups, both groups will receive printed materials about problematics behaviors in dementia.
Participants in the intervention group will receive weekly telephone contacts over a period of eight weeks, previously scheduled with psychoeducational and support in the management of their relatives with dementia. Caregivers in the intervention group will have access to a number of phones to spontaneously contact specific guidelines during the eight weeks of intervention.
Patients from both groups will be interviewed in the baseline, at 8 weeks and 16 weeks.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The individual who evaluates the outcome(s) of interest in this case the applicators of scales and questionnaires
measure: Change from baseline in the caregiver's level of burden
time frame: Week 9
description: Zarit Burden Interview
measure: Change from baseline in the caregiver's level of burden
time frame: Week 18
description: Zarit Burden Interview
measure: Change from baseline in the caregivers's depressive symptoms
time frame: Week 9
description: Beck Depression Inventory
measure: Change from baseline in the caregivers's depressive symptoms
time frame: Week 18
description: Beck Depression Inventory
measure: Change from baseline in the caregivers's anxiety symptoms
time frame: Week 9
description: Beck Anxiety Inventory
measure: Change from baseline in the caregivers's anxiety symptoms
time frame: Week 18
description: Beck Anxiety Inventory
measure: Change from baseline in the caregivers's quality of life
time frame: Week 9
description: Quality of Life Questionnaire - WHOQOL
measure: Change from baseline in the caregivers's quality of life
time frame: Week 18
description: Quality of Life Questionnaire - WHOQOL
measure: Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
time frame: Week 9
description: Neuropsychiatric Inventory - NPI
measure: Change from baseline in the presence and severity of neurosypsychiatric symptoms in the patient
time frame: Week 18
description: Neuropsychiatric Inventory - NPI
measure: Change from baseline in the patient functionality
time frame: Week 9
description: Pfeffer Functional Activities Questionnaire
measure: Change from baseline in the patient functionality
time frame: Week 18
description: Pfeffer Functional Activities Questionnaire
arm group label: Intervention
arm group type: Experimental
description: Telesupport: eight weekly phone calls of psychoeducation and support on the illness of their relatives. Patients will also receive printed materials on problematic behaviors about dementia.
arm group label: Control
arm group type: No Intervention
description: No active intervention. Patients will only receive printed materials on problematic behaviors about dementia and no contact by the research team.
intervention type: Behavioral
intervention name: Telesupport
description: In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
gender description: Female caregivers
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Artur S Schuh, PhD
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
last name: Artur S Schuh, PhD
phone: 33598520
email: schuh.afs@gmail.com
last name: Andressa H Hermes-Pereira, CP
phone: 33598520
email: andressahpereira@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: Undecided