<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/NCT01708304</url>
  </required_header>
  <id_info>
    <org_study_id>41906</org_study_id>
    <nct_id>NCT01708304</nct_id>
  </id_info>
  <brief_title>Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs)</brief_title>
  <acronym>RDAD</acronym>
  <official_title>From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The University of Washington's Northwest Research Group on Aging is partnering with Area&#xD;
      Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation&#xD;
      of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an evidence-based program&#xD;
      with demonstrated efficacy in helping older adults with dementia maintain physical function&#xD;
      and remain physically and mentally healthy. This study asks two questions: 1) Can AAA&#xD;
      partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD&#xD;
      effective in producing desired outcomes among agencies, providers, and older adults with&#xD;
      dementia and their family members. This study is being conducted in Washington and Oregon&#xD;
      states.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minutes of exercise per week</measure>
    <time_frame>Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12</time_frame>
    <description>Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restricted Activity Days</measure>
    <time_frame>Baseline</time_frame>
    <description>Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restricted Activity Days</measure>
    <time_frame>Change from Baseline to Pre-Treatment (6 weeks)</time_frame>
    <description>Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restricted Activity Days</measure>
    <time_frame>Change from Baseline to Post- Treatment 1 (13 weeks)</time_frame>
    <description>Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restricted Activity Days</measure>
    <time_frame>Change from Baseline to Post-Treatment 2 (30 weeks)</time_frame>
    <description>Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Restricted Days of Activity</measure>
    <time_frame>Change from Baseline to 13 Month Follow-Up</time_frame>
    <description>Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Independence/Residential Status</measure>
    <time_frame>Change from Baseline to 13 Month Follow-Up</time_frame>
    <description>All participants will be in independent living situations at baseline. Any move from independent living to a care facility will be documented throughout the 13 month study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC)</measure>
    <time_frame>Baseline</time_frame>
    <description>Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC)</measure>
    <time_frame>Change from Baseline to Pre-Treatment (6 weeks)</time_frame>
    <description>Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC)</measure>
    <time_frame>Change from Baseline to Post-Treatment 1 (13 weeks)</time_frame>
    <description>Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC)</measure>
    <time_frame>Change from Baseline to Post-Treatment 2 (30 weeks)</time_frame>
    <description>Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC)</measure>
    <time_frame>Change from Baseline to 13 Month Follow-Up</time_frame>
    <description>Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life-AD</measure>
    <time_frame>Baseline</time_frame>
    <description>This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life-AD</measure>
    <time_frame>Change from Baseline to Pre-Treatment (6 weeks)</time_frame>
    <description>This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life-AD</measure>
    <time_frame>Change from Baseline to Post-Treatment 1 (13 weeks)</time_frame>
    <description>This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life-AD</measure>
    <time_frame>Change from Baseline to Post-Treatment 2 (30 weeks)</time_frame>
    <description>This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life-AD</measure>
    <time_frame>Change from Baseline to 13 Month Follow-Up</time_frame>
    <description>This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D</measure>
    <time_frame>Baseline</time_frame>
    <description>This 20-item scale that assesses depression in caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D</measure>
    <time_frame>Change from Baseline to Pre-Treatment (6 weeks)</time_frame>
    <description>A 20-item scale that assesses depression in caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D</measure>
    <time_frame>Change from Baseline to Post-Treatment 1 (13 weeks)</time_frame>
    <description>A 20-item scale that assesses depression in caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D</measure>
    <time_frame>Change from Baseline to Post-Treatment 2 (30 weeks)</time_frame>
    <description>A 20-item scale that assesses depression in caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D</measure>
    <time_frame>Change from Baseline to 13 Month Follow-Up</time_frame>
    <description>A 20-item scale that assesses depression in caregivers.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">510</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Dementia</condition>
  <condition>Memory Impairment</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>RDAD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exercise training for caregiver and care recipient. Behavior modification training for caregiver.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RDAD</intervention_name>
    <description>Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.</description>
    <arm_group_label>RDAD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Care Recipients must&#xD;
&#xD;
          -  Have a diagnosis of dementia&#xD;
&#xD;
          -  Be 65 years of age or older&#xD;
&#xD;
          -  Currently exercise no more than 150 minutes a week and not regularly participate in a&#xD;
             formal exercise program.&#xD;
&#xD;
        Caregivers must&#xD;
&#xD;
          -  Live in the community&#xD;
&#xD;
          -  Provide care to the care recipient with dementia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Either Care-recipient or Caregiver must not&#xD;
&#xD;
          -  Plan to move to a long-term residential care setting within 6 months of enrollment.&#xD;
&#xD;
          -  Plan to move from the study geographic area within 4 months of enrollment.&#xD;
&#xD;
          -  Have a known terminal illness (with death anticipated within the next 12 months)&#xD;
&#xD;
          -  Have had a hospitalization for a psychiatric disorder in the 12 months prior to&#xD;
             baseline&#xD;
&#xD;
          -  Be actively suicidal, hallucinating, or delusional&#xD;
&#xD;
          -  Be blind, deaf, or not ambulatory&#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>Linda Teri, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Linda Teri</investigator_full_name>
    <investigator_title>Professor, Psychosocial &amp; Community Health</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Exercise</keyword>
  <keyword>Caregiver</keyword>
  <keyword>Behavior modification</keyword>
  <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/NCT01708304
org study id: 41906
nct id: NCT01708304
lead sponsor: 
has dmc: Yes
The University of Washington's Northwest Research Group on Aging is partnering with Area
      Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation
      of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an evidence-based program
      with demonstrated efficacy in helping older adults with dementia maintain physical function
      and remain physically and mentally healthy. This study asks two questions: 1) Can AAA
      partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD
      effective in producing desired outcomes among agencies, providers, and older adults with
      dementia and their family members. This study is being conducted in Washington and Oregon
      states.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Minutes of exercise per week
time frame: Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12
description: Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.
measure: Restricted Activity Days
time frame: Baseline
description: Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
measure: Restricted Activity Days
time frame: Change from Baseline to Pre-Treatment (6 weeks)
description: Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
measure: Restricted Activity Days
time frame: Change from Baseline to Post- Treatment 1 (13 weeks)
description: Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
measure: Restricted Activity Days
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
description: Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
measure: Restricted Days of Activity
time frame: Change from Baseline to 13 Month Follow-Up
description: Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.
measure: Independence/Residential Status
time frame: Change from Baseline to 13 Month Follow-Up
description: All participants will be in independent living situations at baseline. Any move from independent living to a care facility will be documented throughout the 13 month study.
measure: Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Baseline
description: Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
measure: Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Change from Baseline to Pre-Treatment (6 weeks)
description: Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
measure: Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Change from Baseline to Post-Treatment 1 (13 weeks)
description: Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
measure: Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
description: Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
measure: Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Change from Baseline to 13 Month Follow-Up
description: Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.
measure: Quality of Life-AD
time frame: Baseline
description: This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
measure: Quality of Life-AD
time frame: Change from Baseline to Pre-Treatment (6 weeks)
description: This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
measure: Quality of Life-AD
time frame: Change from Baseline to Post-Treatment 1 (13 weeks)
description: This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
measure: Quality of Life-AD
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
description: This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
measure: Quality of Life-AD
time frame: Change from Baseline to 13 Month Follow-Up
description: This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.
measure: CES-D
time frame: Baseline
description: This 20-item scale that assesses depression in caregivers.
measure: CES-D
time frame: Change from Baseline to Pre-Treatment (6 weeks)
description: A 20-item scale that assesses depression in caregivers.
measure: CES-D
time frame: Change from Baseline to Post-Treatment 1 (13 weeks)
description: A 20-item scale that assesses depression in caregivers.
measure: CES-D
time frame: Change from Baseline to Post-Treatment 2 (30 weeks)
description: A 20-item scale that assesses depression in caregivers.
measure: CES-D
time frame: Change from Baseline to 13 Month Follow-Up
description: A 20-item scale that assesses depression in caregivers.
arm group label: RDAD
arm group type: Other
description: Exercise training for caregiver and care recipient. Behavior modification training for caregiver.
intervention type: Behavioral
intervention name: RDAD
description: Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.
arm group label: RDAD
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Linda Teri, Ph.D.
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Linda Teri
investigator title: Professor, Psychosocial & Community Health
mesh term: Alzheimer Disease
mesh term: Dementia