<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/NCT03828383</url>
  </required_header>
  <id_info>
    <org_study_id>R44AG059458</org_study_id>
    <secondary_id>R44AG059458</secondary_id>
    <nct_id>NCT03828383</nct_id>
  </id_info>
  <brief_title>In-Home Technology for Dementia Caregivers</brief_title>
  <official_title>Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People Power Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Berkeley</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to develop and evaluate in-home assistive technology that is designed to&#xD;
      alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals&#xD;
      with Alzheimer's disease and frontotemporal dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to develop, refine, and evaluate a hardware/software system designed to&#xD;
      integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e.,&#xD;
      devices that can be controlled and communicated with via the internet) technologies to create&#xD;
      a more supportive and safe home environment for caregivers and people with dementia. The&#xD;
      system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets&#xD;
      mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with&#xD;
      dementia with adverse caregiver outcomes (declines in health and well-being). The system is&#xD;
      designed to minimize demands on caregivers' limited time and energy and to provide a platform&#xD;
      for data collection that can be used by researchers and care professionals.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Caregivers in the full operation condition will have fewer negative effects of&#xD;
           caregiving (lower burden, higher mental and physical health, higher well-being) than&#xD;
           those in the limited home safety condition.&#xD;
&#xD;
        2. Greater use of the social networking features of the system will be associated with&#xD;
           fewer caregiver depressive symptoms.&#xD;
&#xD;
        3. Greater utilization of the home safety features of the system will be associated with&#xD;
           fewer caregiver anxiety symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">November 27, 2020</completion_date>
  <primary_completion_date type="Actual">November 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Zarit Burden Interview-Short Form</measure>
    <time_frame>9 months after baseline</time_frame>
    <description>Questionnaire to measure caregiver burden (Zarit, Reever, &amp; Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale (CES-D)</measure>
    <time_frame>9 months after baseline</time_frame>
    <description>Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>9 months after baseline</time_frame>
    <description>Questionnaire to measure anxiety (Beck, Epstein, Brown, &amp; Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction With Life Scale</measure>
    <time_frame>9 months after baseline</time_frame>
    <description>Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, &amp; Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer's Disease</condition>
  <condition>Frontotemporal Dementia</condition>
  <arm_group>
    <arm_group_label>In-Home Technology System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limited In-Home Technology System</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>In-home technology</intervention_name>
    <description>Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
    <arm_group_label>In-Home Technology System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Limited in-home technology</intervention_name>
    <description>Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
    <arm_group_label>Limited In-Home Technology System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caregivers are fluent/literate in English&#xD;
&#xD;
          -  Caregivers currently reside with spouse/family member with dementia&#xD;
&#xD;
          -  Caregivers primarily use an iPhone&#xD;
&#xD;
          -  Caregiver has wireless internet in home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregivers providing care for individuals with known non-neurodegenerative conditions&#xD;
             affecting behavior and cognition&#xD;
&#xD;
          -  Caregivers providing care for individuals with longstanding Axis I psychiatric&#xD;
             disorder&#xD;
&#xD;
          -  Caregivers providing care for individuals with metabolic disorder or major organ&#xD;
             dysfunction&#xD;
&#xD;
          -  Caregivers providing care for individuals with alcohol abuse or dependence (within 5&#xD;
             years of dementia onset)&#xD;
&#xD;
          -  Caregivers providing care for individuals with head trauma with loss of consciousness&#xD;
             greater than 30 minutes&#xD;
&#xD;
          -  Caregivers providing care for individuals with contraindications to MRI imaging&#xD;
&#xD;
          -  Caregivers providing care for individuals with large confluent white matter lesions&#xD;
&#xD;
          -  Caregivers providing care for individuals with significant systemic medical illness&#xD;
&#xD;
          -  Caregivers providing care for individuals who use a medication likely to affect&#xD;
             central nervous system functions adversely&#xD;
&#xD;
        If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los&#xD;
        Angeles County, or Oregon, you may complete the following screening questionnaire to&#xD;
        determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the&#xD;
        screening questionnaire, the UC Berkeley research team will follow up soon after by email&#xD;
        or phone to confirm your eligibility status.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert W Levenson, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>University of California, Berkeley</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Berkeley</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles County</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92856</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clark County</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.</citation>
    <PMID>29216633</PMID>
  </reference>
  <reference>
    <citation>Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.</citation>
    <PMID>28655841</PMID>
  </reference>
  <reference>
    <citation>Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.</citation>
    <PMID>28395276</PMID>
  </reference>
  <reference>
    <citation>Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.</citation>
    <PMID>29289452</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>March 9, 2022</results_first_submitted>
  <results_first_submitted_qc>April 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2022</results_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Berkeley</investigator_affiliation>
    <investigator_full_name>Robert Levenson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Caregivers</keyword>
  <keyword>Dementia</keyword>
  <keyword>In-Home Assistive Technology</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>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Because patient and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 12, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03828383/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 12, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03828383/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Note that outcomes are only assessed regarding caregiver health and well-being. Patients did not provide any information; therefore, all information reported for demographics and measures is only regarding caregivers.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>In-Home Technology System</title>
          <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
        </group>
        <group group_id="P2">
          <title>Limited In-Home Technology System</title>
          <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Although 78 individuals originally consented to being in the study, 9 individuals dropped out between consenting/enrolling and completing the baseline questionnaire assessing baseline outcome measures; therefore, these baseline numbers only include 69 participants.</population>
      <group_list>
        <group group_id="B1">
          <title>In-Home Technology System</title>
          <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
        </group>
        <group group_id="B2">
          <title>Limited In-Home Technology System</title>
          <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</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="37"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="69"/>
          </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="63.38" spread="12.70"/>
                    <measurement group_id="B2" value="65.91" spread="10.75"/>
                    <measurement group_id="B3" value="65.01" spread="11.63"/>
                  </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="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>East Asian, South Asian, Southeast Asian, or Indian American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latino or Hispanic American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic White or European American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Zarit Burden Interview-Short Form</title>
        <description>Questionnaire to measure caregiver burden (Zarit, Reever, &amp; Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.</description>
        <time_frame>9 months after baseline</time_frame>
        <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
          </group>
          <group group_id="O2">
            <title>Limited In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Interview-Short Form</title>
          <description>Questionnaire to measure caregiver burden (Zarit, Reever, &amp; Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.</description>
          <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
          <units>score 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="33"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.58" spread="8.09"/>
                    <measurement group_id="O2" value="25.59" spread="8.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Center for Epidemiological Studies Depression Scale (CES-D)</title>
        <description>Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.</description>
        <time_frame>9 months after baseline</time_frame>
        <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
          </group>
          <group group_id="O2">
            <title>Limited In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
          </group>
        </group_list>
        <measure>
          <title>Center for Epidemiological Studies Depression Scale (CES-D)</title>
          <description>Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.</description>
          <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
          <units>score 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="34"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.21" spread="12.03"/>
                    <measurement group_id="O2" value="19.30" spread="12.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Beck Anxiety Inventory (BAI)</title>
        <description>Questionnaire to measure anxiety (Beck, Epstein, Brown, &amp; Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.</description>
        <time_frame>9 months after baseline</time_frame>
        <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
          </group>
          <group group_id="O2">
            <title>Limited In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI)</title>
          <description>Questionnaire to measure anxiety (Beck, Epstein, Brown, &amp; Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.</description>
          <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
          <units>score 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="34"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.74" spread="6.82"/>
                    <measurement group_id="O2" value="11.20" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Satisfaction With Life Scale</title>
        <description>Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, &amp; Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.</description>
        <time_frame>9 months after baseline</time_frame>
        <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
          </group>
          <group group_id="O2">
            <title>Limited In-Home Technology System</title>
            <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Life Scale</title>
          <description>Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, &amp; Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.</description>
          <population>78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.35" spread="7.36"/>
                    <measurement group_id="O2" value="19.00" spread="6.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 9 months</time_frame>
      <desc>Although 78 individuals originally enrolled in the study, only 69 individuals completed the baseline assessment. Therefore, the number for those at risk only reflect the 69 individuals for whom we had a baseline assessment.</desc>
      <group_list>
        <group group_id="E1">
          <title>In-Home Technology System</title>
          <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.</description>
        </group>
        <group group_id="E2">
          <title>Limited In-Home Technology System</title>
          <description>The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).&#xD;
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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>
    <limitations_and_caveats>The study intended to recruit 80 participants, 78 individuals did complete the consent form, however towards the end of enrollment, COVID-19 shutdowns occurred and our local IRB (UC Berkeley) did not allow in-person contact with participants, which ruled out the ability to install the treatment (technology) in participants' homes. The total number of participants was 69.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Robert W. Levenson</name_or_title>
      <organization>University of California, Berkeley</organization>
      <phone>510-643-8952</phone>
      <email>boblev@berkeley.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/NCT03828383
org study id: R44AG059458
secondary id: R44AG059458
nct id: NCT03828383
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to develop and evaluate in-home assistive technology that is designed to
      alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals
      with Alzheimer's disease and frontotemporal dementia.
This study aims to develop, refine, and evaluate a hardware/software system designed to
      integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e.,
      devices that can be controlled and communicated with via the internet) technologies to create
      a more supportive and safe home environment for caregivers and people with dementia. The
      system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets
      mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with
      dementia with adverse caregiver outcomes (declines in health and well-being). The system is
      designed to minimize demands on caregivers' limited time and energy and to provide a platform
      for data collection that can be used by researchers and care professionals.

      Hypotheses:

        1. Caregivers in the full operation condition will have fewer negative effects of
           caregiving (lower burden, higher mental and physical health, higher well-being) than
           those in the limited home safety condition.

        2. Greater use of the social networking features of the system will be associated with
           fewer caregiver depressive symptoms.

        3. Greater utilization of the home safety features of the system will be associated with
           fewer caregiver anxiety symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
masking description: Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.
measure: Zarit Burden Interview-Short Form
time frame: 9 months after baseline
description: Questionnaire to measure caregiver burden (Zarit, Reever, & Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
measure: Center for Epidemiological Studies Depression Scale (CES-D)
time frame: 9 months after baseline
description: Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
measure: Beck Anxiety Inventory (BAI)
time frame: 9 months after baseline
description: Questionnaire to measure anxiety (Beck, Epstein, Brown, & Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
measure: Satisfaction With Life Scale
time frame: 9 months after baseline
description: Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, & Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
arm group label: In-Home Technology System
arm group type: Experimental
description: The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
arm group label: Limited In-Home Technology System
arm group type: Sham Comparator
description: The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
intervention type: Device
intervention name: In-home technology
description: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
arm group label: In-Home Technology System
intervention type: Device
intervention name: Limited in-home technology
description: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
arm group label: Limited In-Home Technology System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert W Levenson, Ph.D.
role: Study Director
affiliation: University of California, Berkeley
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.
PMID: 29216633
citation: Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.
PMID: 28655841
citation: Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.
PMID: 28395276
citation: Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.
PMID: 29289452
responsible party type: Principal Investigator
investigator affiliation: University of California, Berkeley
investigator full name: Robert Levenson
investigator title: Professor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
sharing ipd: Undecided
ipd description: Because patient and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study intended to recruit 80 participants, 78 individuals did complete the consent form, however towards the end of enrollment, COVID-19 shutdowns occurred and our local IRB (UC Berkeley) did not allow in-person contact with participants, which ruled out the ability to install the treatment (technology) in participants' homes. The total number of participants was 69.
point of contact: 