<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/NCT02256072</url>
  </required_header>
  <id_info>
    <org_study_id>IH-12-11-4259</org_study_id>
    <nct_id>NCT02256072</nct_id>
  </id_info>
  <brief_title>Advance Planning for Home Services for Seniors</brief_title>
  <acronym>APHS</acronym>
  <official_title>Advance Planning for Home Services for Seniors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to develop and test an advance planning tool to help seniors&#xD;
      understand projected health needs and plan ways to remain in their own homes when these&#xD;
      crises occur. In this phase of the study through partnerships with seniors, senior community&#xD;
      groups, area agencies on aging, and home care agencies the investigators are conducting a&#xD;
      two-armed (attention control and intervention) randomized controlled trial.&#xD;
&#xD;
      Individuals will be randomly assigned to one of two interventions: attention control or the&#xD;
      advance planning tool. The investigators attention control group will control for the&#xD;
      possibility that regular contact with the study team may improve outcomes in participants&#xD;
      randomized to the intervention website. Participants in the attention control arm will&#xD;
      navigate an electronic educational session via a National Institute on Aging at NIH Web site&#xD;
      about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15&#xD;
      minutes and a maximum of 45 minutes will be allotted for navigating the Web site. The Web&#xD;
      site is interactive and comparable to the intervention tool:&#xD;
      http://go4life.nia.nih.gov/get-started).&#xD;
&#xD;
      If randomized to intervention, subjects will be introduced to the advance planning tool, the&#xD;
      Plan Your Lifespan website, and given instructions on how to use it. Plan Your Lifespan is a&#xD;
      Web-based planning tool that provides information for seniors related to advanced health&#xD;
      planning for home services in specific content areas of: hospitalizations, falls,&#xD;
      Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan website&#xD;
      is also interactive in that it allows participants to enter their information and share it&#xD;
      with others to facilitate conversations and decision-making. Participants will navigate and&#xD;
      complete the Web-based advance planning tool and will be allotted a minimum of 15 minutes and&#xD;
      a maximum of 45 minutes to navigate the tool as part of the study.&#xD;
&#xD;
      All participants will be administered a pre- and post-test before and after viewing the&#xD;
      website they were randomized to. All participants will be followed up at one and three months&#xD;
      post via a brief phone call where follow-up questions will be asked of all participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Seniors over the age of 65 years represent 13.1% of the United States population, with a&#xD;
      projected 36% increase to 55 million by the year 2020. With advancing age, seniors experience&#xD;
      an increased prevalence in memory loss, physical disability, and multiple chronic conditions&#xD;
      (e.g., heart disease, emphysema, stroke, diabetes, cancers, hypertension, arthritis,&#xD;
      osteoporosis, and macular degeneration). A large fear among seniors is loss of independence&#xD;
      and removal from their homes to be placed in a nursing home. Seniors who remain in their own&#xD;
      homes tend to have greater satisfaction, less depression, and maintain their physical&#xD;
      function better than seniors residing in assisted living or nursing homes. Although remaining&#xD;
      in the home is of utmost importance, many frail seniors teeter between safe living and&#xD;
      personal endangerment. Falls, illness, and worsening memory all jeopardize a senior's&#xD;
      independence and ability to remain in his or her home.&#xD;
&#xD;
      The advance planning tool, Plan Your Lifespan, provides information that will help older&#xD;
      Americans to &quot;fill in the gaps&quot; in their lives as necessary. An established plan would offer&#xD;
      guidance toward obtaining those resources and professional services that would be useful to&#xD;
      the senior. An effective plan would be dynamic and adaptable to the senior's changing health&#xD;
      needs.&#xD;
&#xD;
      The aim of this study is to conduct a randomized controlled trial of the advance planning&#xD;
      tool to determine subject understanding of home care services, advanced health planning, and&#xD;
      other patient-centered outcomes. The investigators also hypothesize the following:&#xD;
&#xD;
      H1: Compared to participants in the attention control group and controlling for baseline&#xD;
      assessments, participants receiving the advance planning tool will show increased planning&#xD;
      with regard to implementation/behavior, perception, and intention (measured via the Planning&#xD;
      Assessment tool) one month after intervention.&#xD;
&#xD;
      H2: Compared to participants in the attention control group and controlling for baseline&#xD;
      assessments, participants receiving the advance planning tool will show increased confidence&#xD;
      in accessing home services (measured via the Confidence in Accessing Home Services tool) one&#xD;
      month after intervention.&#xD;
&#xD;
      H3: Compared to participants in the attention control group and controlling for baseline&#xD;
      assessments, participants receiving the advance planning tool will show increased&#xD;
      understanding of home services (measured via the Understanding of Home Services tool) one&#xD;
      month after intervention.&#xD;
&#xD;
      H4: Compared to participants in the attention control group and controlling for baseline&#xD;
      assessments, participants receiving the advance planning tool will be more likely to report&#xD;
      communicating their preferences about issues related to lifespan planning to people who may&#xD;
      need to make decisions for them (measured via the Communication about Lifespan Planning&#xD;
      Questionnaire) after study intervention.&#xD;
&#xD;
      H5: Compared to participants in the attention control group, participants randomized to the&#xD;
      advance planning tool will report overall satisfaction with the intervention/attention&#xD;
      control (measured via the Satisfaction with Intervention tool).&#xD;
&#xD;
      The total duration of the intervention for each participant will be three months with&#xD;
      assessments at baseline, post-intervention, and two follow-up assessments at one and three&#xD;
      months for a total of 4 data collection points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Planning Behavior Score at 1-month</measure>
    <time_frame>baseline and 1 month</time_frame>
    <description>The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the &quot;Planning Implementation (Behavior)&quot; assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months</measure>
    <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
    <description>Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the &quot;Planning Perception&quot; assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months</measure>
    <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
    <description>Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months</measure>
    <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
    <description>Knowledge of home services score at all follow-up time points as measured by &quot;Understanding of Home Services&quot; assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months</measure>
    <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
    <description>Overall satisfaction with the intervention or attention control as measured by the &quot;Satisfaction with Intervention Tool.&quot; Tests will be performed at a two-sided 5% significance level.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">385</enrollment>
  <condition>Alzheimers, Falls, Aging in Place</condition>
  <arm_group>
    <arm_group_label>Plan Your Lifespan Website</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Go4Life Website</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plan Your Lifespan Website</intervention_name>
    <description>Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.</description>
    <arm_group_label>Plan Your Lifespan Website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Go4Life Website</intervention_name>
    <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
    <arm_group_label>Go4Life Website</arm_group_label>
    <other_name>National Institute on Aging at NIH Website</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 and older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Score ≥ 4 questions correctly on the Brief Cognitive screener&#xD;
&#xD;
          -  Self-identified comfort using a computer&#xD;
&#xD;
          -  Self-identified comfort using the Internet to navigate a Website&#xD;
&#xD;
          -  Have not previously participated in study's focus groups or pilot study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than age 65&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Score &lt; 4 questions correctly on the Brief Cognitive screener&#xD;
&#xD;
          -  Not comfortable using a computer&#xD;
&#xD;
          -  Not comfortable using the Internet to navigate a Website&#xD;
&#xD;
          -  Previous participation in this study's focus groups or pilot study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee A Lindquist, MD, MPH, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aging &amp; In-Home Services of Northeast Indiana</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>August 5, 2016</results_first_submitted>
  <results_first_submitted_qc>December 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2017</results_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 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>Northwestern University</investigator_affiliation>
    <investigator_full_name>Lee Lindquist</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Associate Division Chief of Geriatrics</investigator_title>
  </responsible_party>
  <keyword>aging, geriatrics, aging in place, home services</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment for this study took place between October 1, 2014 and September 30, 2015.</recruitment_details>
      <pre_assignment_details>Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach ). All participants reached randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Plan Your Lifespan Website</title>
          <description>Participants in the intervention arm will navigate PlanYourLifespan.org.</description>
        </group>
        <group group_id="P2">
          <title>Go4Life Website</title>
          <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="194"/>
                <participants group_id="P2" count="191"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 1 Month Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="167">Completed the 1-month follow-up</participants>
                <participants group_id="P2" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152">Completed the 3-month follow-up</participants>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Plan Your Lifespan Website</title>
          <description>Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.&#xD;
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte</description>
        </group>
        <group group_id="B2">
          <title>Go4Life Website</title>
          <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="194"/>
            <count group_id="B2" value="191"/>
            <count group_id="B3" value="385"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.67" spread="5.56"/>
                    <measurement group_id="B2" value="72.05" spread="5.57"/>
                    <measurement group_id="B3" value="71.86" spread="5.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="306"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White or Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Single, never married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Divorced/Separated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <description>Reported education</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>High school or less</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Income</title>
          <description>Self-reported combined annual household income.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>less than $20,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$20,000-$40,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$40,001-$60,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$60,001-$80,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$80,001-$100,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than $100,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Sure/Don't Know</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer not to say</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Reported Health Rating</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Living Arrangement</title>
          <description>Self-reported current living arrangement.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Live alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Live with one other person</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Live with multiple people (more than one)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>REALM-R</title>
          <description>REALM-R score.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Low Literacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marginal Literacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adequate Literacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="159"/>
                    <measurement group_id="B3" value="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Planning Behavior Score at 1-month</title>
        <description>The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the &quot;Planning Implementation (Behavior)&quot; assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.</description>
        <time_frame>baseline and 1 month</time_frame>
        <population>All randomized participants with a complete planning behavior score at baseline and one-month.</population>
        <group_list>
          <group group_id="O1">
            <title>Plan Your Lifespan Website</title>
            <description>Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.&#xD;
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte</description>
          </group>
          <group group_id="O2">
            <title>Go4Life Website</title>
            <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
          </group>
        </group_list>
        <measure>
          <title>Planning Behavior Score at 1-month</title>
          <description>The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the &quot;Planning Implementation (Behavior)&quot; assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.</description>
          <population>All randomized participants with a complete planning behavior score at baseline and one-month.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Planning Behavior Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.97" spread="4.38"/>
                    <measurement group_id="O2" value="16.80" spread="4.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Planning Behavior Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.19" spread="4.48"/>
                    <measurement group_id="O2" value="15.88" spread="4.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0054</p_value>
            <method>ANCOVA</method>
            <param_type>Slope</param_type>
            <param_value>1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months</title>
        <description>Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the &quot;Planning Perception&quot; assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.</description>
        <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
        <population>Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.</population>
        <group_list>
          <group group_id="O1">
            <title>Plan Your Lifespan Website</title>
            <description>Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.&#xD;
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte</description>
          </group>
          <group group_id="O2">
            <title>Go4Life Website</title>
            <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
          </group>
        </group_list>
        <measure>
          <title>Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months</title>
          <description>Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the &quot;Planning Perception&quot; assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.</description>
          <population>Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Planning Perception Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.75" spread="4.02"/>
                    <measurement group_id="O2" value="20.11" spread="3.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Tool Planning Perception Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.70" spread="3.85"/>
                    <measurement group_id="O2" value="20.01" spread="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One-Month Planning Perception Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.75" spread="3.69"/>
                    <measurement group_id="O2" value="20.29" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three-Month Planning Perception Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.14" spread="3.55"/>
                    <measurement group_id="O2" value="20.81" spread="3.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0471</p_value>
            <p_value_desc>P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The p-value is based on the slope estimation provided below.</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.244</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.123</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months</title>
        <description>Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.</description>
        <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
        <population>Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.</population>
        <group_list>
          <group group_id="O1">
            <title>Plan Your Lifespan Website</title>
            <description>Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.&#xD;
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte</description>
          </group>
          <group group_id="O2">
            <title>Go4Life Website</title>
            <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
          </group>
        </group_list>
        <measure>
          <title>Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months</title>
          <description>Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.</description>
          <population>Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline CAHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.85" spread="3.29"/>
                    <measurement group_id="O2" value="20.70" spread="3.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Tool CAHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.39" spread="2.89"/>
                    <measurement group_id="O2" value="20.67" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One-Month CAHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.74" spread="2.62"/>
                    <measurement group_id="O2" value="21.19" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three-Month CAHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.17" spread="2.33"/>
                    <measurement group_id="O2" value="21.70" spread="2.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.423</p_value>
            <p_value_desc>p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The p-value is based on the slope estimation provided below.</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.075</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.094</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months</title>
        <description>Knowledge of home services score at all follow-up time points as measured by &quot;Understanding of Home Services&quot; assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.</description>
        <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
        <population>Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.</population>
        <group_list>
          <group group_id="O1">
            <title>Plan Your Lifespan Website</title>
            <description>Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.&#xD;
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte</description>
          </group>
          <group group_id="O2">
            <title>Go4Life Website</title>
            <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
          </group>
        </group_list>
        <measure>
          <title>Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months</title>
          <description>Knowledge of home services score at all follow-up time points as measured by &quot;Understanding of Home Services&quot; assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.</description>
          <population>Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline UHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" spread="1.28"/>
                    <measurement group_id="O2" value="3.79" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Tool UHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.12" spread="1.26"/>
                    <measurement group_id="O2" value="3.93" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One-Month UHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="1.35"/>
                    <measurement group_id="O2" value="3.72" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three-Month UHS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.18" spread="1.45"/>
                    <measurement group_id="O2" value="3.73" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The p-value is based on the slope estimation provided below.</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months</title>
        <description>Overall satisfaction with the intervention or attention control as measured by the &quot;Satisfaction with Intervention Tool.&quot; Tests will be performed at a two-sided 5% significance level.</description>
        <time_frame>baseline, post-intervention, 1 month, and 3 months</time_frame>
        <population>Due to errors in the data collection method, it is not possible to summarize the data for reporting.</population>
        <group_list>
          <group group_id="O1">
            <title>Plan Your Lifespan Website</title>
            <description>Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas described below.&#xD;
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.</description>
          </group>
          <group group_id="O2">
            <title>Go4Life Website</title>
            <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months</title>
          <description>Overall satisfaction with the intervention or attention control as measured by the &quot;Satisfaction with Intervention Tool.&quot; Tests will be performed at a two-sided 5% significance level.</description>
          <population>Due to errors in the data collection method, it is not possible to summarize the data for reporting.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Plan Your Lifespan Website</title>
          <description>Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.&#xD;
PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.</description>
        </group>
        <group group_id="E2">
          <title>Go4Life Website</title>
          <description>Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.&#xD;
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="194"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="194"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="191"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Lee A. Lindquist</name_or_title>
      <organization>Northwestern University Feinberg School of Medicine</organization>
      <phone>312-503-3916</phone>
      <email>LAL425@md.northwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02256072
org study id: IH-12-11-4259
nct id: NCT02256072
lead sponsor: 
collaborator: 
has dmc: No
The goal of this study is to develop and test an advance planning tool to help seniors
      understand projected health needs and plan ways to remain in their own homes when these
      crises occur. In this phase of the study through partnerships with seniors, senior community
      groups, area agencies on aging, and home care agencies the investigators are conducting a
      two-armed (attention control and intervention) randomized controlled trial.

      Individuals will be randomly assigned to one of two interventions: attention control or the
      advance planning tool. The investigators attention control group will control for the
      possibility that regular contact with the study team may improve outcomes in participants
      randomized to the intervention website. Participants in the attention control arm will
      navigate an electronic educational session via a National Institute on Aging at NIH Web site
      about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15
      minutes and a maximum of 45 minutes will be allotted for navigating the Web site. The Web
      site is interactive and comparable to the intervention tool:
      http://go4life.nia.nih.gov/get-started).

      If randomized to intervention, subjects will be introduced to the advance planning tool, the
      Plan Your Lifespan website, and given instructions on how to use it. Plan Your Lifespan is a
      Web-based planning tool that provides information for seniors related to advanced health
      planning for home services in specific content areas of: hospitalizations, falls,
      Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan website
      is also interactive in that it allows participants to enter their information and share it
      with others to facilitate conversations and decision-making. Participants will navigate and
      complete the Web-based advance planning tool and will be allotted a minimum of 15 minutes and
      a maximum of 45 minutes to navigate the tool as part of the study.

      All participants will be administered a pre- and post-test before and after viewing the
      website they were randomized to. All participants will be followed up at one and three months
      post via a brief phone call where follow-up questions will be asked of all participants.
Seniors over the age of 65 years represent 13.1% of the United States population, with a
      projected 36% increase to 55 million by the year 2020. With advancing age, seniors experience
      an increased prevalence in memory loss, physical disability, and multiple chronic conditions
      (e.g., heart disease, emphysema, stroke, diabetes, cancers, hypertension, arthritis,
      osteoporosis, and macular degeneration). A large fear among seniors is loss of independence
      and removal from their homes to be placed in a nursing home. Seniors who remain in their own
      homes tend to have greater satisfaction, less depression, and maintain their physical
      function better than seniors residing in assisted living or nursing homes. Although remaining
      in the home is of utmost importance, many frail seniors teeter between safe living and
      personal endangerment. Falls, illness, and worsening memory all jeopardize a senior's
      independence and ability to remain in his or her home.

      The advance planning tool, Plan Your Lifespan, provides information that will help older
      Americans to "fill in the gaps" in their lives as necessary. An established plan would offer
      guidance toward obtaining those resources and professional services that would be useful to
      the senior. An effective plan would be dynamic and adaptable to the senior's changing health
      needs.

      The aim of this study is to conduct a randomized controlled trial of the advance planning
      tool to determine subject understanding of home care services, advanced health planning, and
      other patient-centered outcomes. The investigators also hypothesize the following:

      H1: Compared to participants in the attention control group and controlling for baseline
      assessments, participants receiving the advance planning tool will show increased planning
      with regard to implementation/behavior, perception, and intention (measured via the Planning
      Assessment tool) one month after intervention.

      H2: Compared to participants in the attention control group and controlling for baseline
      assessments, participants receiving the advance planning tool will show increased confidence
      in accessing home services (measured via the Confidence in Accessing Home Services tool) one
      month after intervention.

      H3: Compared to participants in the attention control group and controlling for baseline
      assessments, participants receiving the advance planning tool will show increased
      understanding of home services (measured via the Understanding of Home Services tool) one
      month after intervention.

      H4: Compared to participants in the attention control group and controlling for baseline
      assessments, participants receiving the advance planning tool will be more likely to report
      communicating their preferences about issues related to lifespan planning to people who may
      need to make decisions for them (measured via the Communication about Lifespan Planning
      Questionnaire) after study intervention.

      H5: Compared to participants in the attention control group, participants randomized to the
      advance planning tool will report overall satisfaction with the intervention/attention
      control (measured via the Satisfaction with Intervention tool).

      The total duration of the intervention for each participant will be three months with
      assessments at baseline, post-intervention, and two follow-up assessments at one and three
      months for a total of 4 data collection points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Planning Behavior Score at 1-month
time frame: baseline and 1 month
description: The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the "Planning Implementation (Behavior)" assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.
measure: Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
description: Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the "Planning Perception" assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.
measure: Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
description: Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.
measure: Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
description: Knowledge of home services score at all follow-up time points as measured by "Understanding of Home Services" assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.
measure: Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
description: Overall satisfaction with the intervention or attention control as measured by the "Satisfaction with Intervention Tool." Tests will be performed at a two-sided 5% significance level.
arm group label: Plan Your Lifespan Website
arm group type: Experimental
description: Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
arm group label: Go4Life Website
arm group type: Other
description: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
intervention type: Other
intervention name: Plan Your Lifespan Website
description: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
arm group label: Plan Your Lifespan Website
intervention type: Other
intervention name: Go4Life Website
description: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
arm group label: Go4Life Website
other name: National Institute on Aging at NIH Website
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lee A Lindquist, MD, MPH, MBA
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Lee Lindquist
investigator title: Associate Professor of Medicine, Associate Division Chief of Geriatrics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 