<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/NCT01715181</url>
  </required_header>
  <id_info>
    <org_study_id>VALIDII</org_study_id>
    <secondary_id>NIRG-12-236827</secondary_id>
    <nct_id>NCT01715181</nct_id>
  </id_info>
  <brief_title>Volunteers Adding Life in Dementia: VALID</brief_title>
  <acronym>VALID</acronym>
  <official_title>A Cluster-Randomized Controlled Trial Evaluating the Effects of a Volunteer-Led Nonpharmacological Intervention to Reduce Neuropsychiatric Symptoms of Dementia in Long-Term Care Residents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alzheimer's Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older adults with Alzheimer's disease and other forms of dementia frequently develop&#xD;
      challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological&#xD;
      strategies to manage these symptoms such as music, exercise, and participating in pleasant&#xD;
      social events have been demonstrated to be safe and effective strategies to reduce these&#xD;
      behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and&#xD;
      implement a volunteer-led program to reduce behavioral symptoms and improve the quality of&#xD;
      life of older adults with dementia who are residing in long-term care facilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of older adults with Alzheimer's disease (AD) and related forms of dementia is&#xD;
      increasing in Canada and the majority of individuals with dementia develop neuropsychiatric&#xD;
      symptoms (NPS) such as agitation, psychosis, depression and anxiety at some time during their&#xD;
      illness. NPS are particularly problematic in long-term care (LTC) where approximately 60% of&#xD;
      individuals have dementia, and 80% of individuals with dementia have NPS at any time. Adverse&#xD;
      outcomes associated with NPS include increased use of psychotropic medications, stress for&#xD;
      families and nursing staff, increased costs of care, and decreased quality of life. A novel&#xD;
      approach to implementing non-pharmacological interventions for LTC residents with NPS is the&#xD;
      use of volunteers. Volunteer-led programs have been demonstrated to be an effective,&#xD;
      inexpensive, and sustainable method of implementing psychosocial interventions for older&#xD;
      adults in acute care. The objectives of our project are to: 1.) Recruit and train&#xD;
      approximately 40 volunteers in the VALID program; 2.) Conduct a cluster-randomized controlled&#xD;
      trial of the VALID program in 6 LTC facilities (3 intervention and 3 control LTC sites; 60&#xD;
      individuals with dementia in each of the experimental and control arms) to determine the&#xD;
      effect of the VALID program on symptoms of NPS, patient quality of life, volunteer's&#xD;
      experience, and LTC staff stress, 3.) Determine key components of the VALID program that&#xD;
      served as facilitators and barriers to implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)</measure>
    <time_frame>Baseline, weeks 2,4,6,8 and 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Neuropsychiatric Inventory score</measure>
    <time_frame>Baseline, weeks 4, 8, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cornell Depression in Dementia Rating Scale score</measure>
    <time_frame>Baseline, weeks 4, 8, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dementia Quality of Life Scale (DEMQoL) score</measure>
    <time_frame>Baseline, weeks 4, 8, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression of Change (CGI-C)score</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Modified nursing care assessment scale (M-NACS)</measure>
    <time_frame>Baseline, week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Short Form Health Survey</measure>
    <time_frame>Baseline, week 12</time_frame>
    <description>Assessment of volunteer quality of life</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals will receive usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volunteer visits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Volunteer visits</intervention_name>
    <description>Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.</description>
    <arm_group_label>Volunteer visits</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Alzheimer's disease or related forms of dementia&#xD;
&#xD;
          -  significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory&#xD;
             (CMAI) total score of &gt;39&#xD;
&#xD;
          -  resident in LTC facility for at least 30 days&#xD;
&#xD;
          -  presence of a caregiver or substitute decision maker willing to consent to treatment&#xD;
&#xD;
          -  no changes in psychotropic medications in the 2 weeks preceding enrolment in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  depressive symptoms presenting acute risk (i.e. suicidal ideation)&#xD;
&#xD;
          -  physically aggressive behavior posing safety risk to others&#xD;
&#xD;
          -  uncontrolled pain&#xD;
&#xD;
          -  currently receiving palliative care&#xD;
&#xD;
          -  medically unstable with life expectancy of &lt; 6 months&#xD;
&#xD;
          -  currently awaiting transfer to another LTC facility or hospital&#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>Dallas P Seitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen's University</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L3N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Dallas Seitz</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <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/NCT01715181
org study id: VALIDII
secondary id: NIRG-12-236827
nct id: NCT01715181
lead sponsor: 
collaborator: 
has dmc: No
Older adults with Alzheimer's disease and other forms of dementia frequently develop
      challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological
      strategies to manage these symptoms such as music, exercise, and participating in pleasant
      social events have been demonstrated to be safe and effective strategies to reduce these
      behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and
      implement a volunteer-led program to reduce behavioral symptoms and improve the quality of
      life of older adults with dementia who are residing in long-term care facilities.
The number of older adults with Alzheimer's disease (AD) and related forms of dementia is
      increasing in Canada and the majority of individuals with dementia develop neuropsychiatric
      symptoms (NPS) such as agitation, psychosis, depression and anxiety at some time during their
      illness. NPS are particularly problematic in long-term care (LTC) where approximately 60% of
      individuals have dementia, and 80% of individuals with dementia have NPS at any time. Adverse
      outcomes associated with NPS include increased use of psychotropic medications, stress for
      families and nursing staff, increased costs of care, and decreased quality of life. A novel
      approach to implementing non-pharmacological interventions for LTC residents with NPS is the
      use of volunteers. Volunteer-led programs have been demonstrated to be an effective,
      inexpensive, and sustainable method of implementing psychosocial interventions for older
      adults in acute care. The objectives of our project are to: 1.) Recruit and train
      approximately 40 volunteers in the VALID program; 2.) Conduct a cluster-randomized controlled
      trial of the VALID program in 6 LTC facilities (3 intervention and 3 control LTC sites; 60
      individuals with dementia in each of the experimental and control arms) to determine the
      effect of the VALID program on symptoms of NPS, patient quality of life, volunteer's
      experience, and LTC staff stress, 3.) Determine key components of the VALID program that
      served as facilitators and barriers to implementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)
time frame: Baseline, weeks 2,4,6,8 and 12
measure: Change in Neuropsychiatric Inventory score
time frame: Baseline, weeks 4, 8, 12
measure: Change in Cornell Depression in Dementia Rating Scale score
time frame: Baseline, weeks 4, 8, 12
measure: Change in Dementia Quality of Life Scale (DEMQoL) score
time frame: Baseline, weeks 4, 8, 12
measure: Change in Clinical Global Impression of Change (CGI-C)score
time frame: 12 weeks
measure: Modified nursing care assessment scale (M-NACS)
time frame: Baseline, week 12
measure: Short Form Health Survey
time frame: Baseline, week 12
description: Assessment of volunteer quality of life
arm group label: Usual care
arm group type: No Intervention
description: Individuals will receive usual care
arm group label: Volunteer visits
arm group type: Experimental
description: Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
intervention type: Other
intervention name: Volunteer visits
description: Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
arm group label: Volunteer visits
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Dallas P Seitz, MD
role: Principal Investigator
affiliation: Queen's University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Dallas Seitz
investigator title: Assistant Professor
mesh term: Alzheimer Disease
mesh term: Dementia