<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/NCT03297268</url>
  </required_header>
  <id_info>
    <org_study_id>0037457000</org_study_id>
    <secondary_id>1418622</secondary_id>
    <nct_id>NCT03297268</nct_id>
  </id_info>
  <brief_title>Behavioral and Environmental Sensing and Intervention</brief_title>
  <acronym>BESI</acronym>
  <official_title>Behavioral and Environmental Sensing and Intervention for Dementia Caregiver Empowerment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carilion Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Carolina Agriculture &amp; Technical State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This 3-phase research plan to employ Behavioral and Environmental Sensing and Intervention&#xD;
      (BESI) will overcome the fundamental scientific barriers to realizing prediction of agitation&#xD;
      episodes and detection early stages of dementia related agitation. The goal of which is&#xD;
      empowering caregivers to intervene early and ultimately reduce agitation, thus reducing&#xD;
      caregiver burden and extending aging-in-place and improving the associated quality-of-life&#xD;
      and cost benefits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dementia syndrome of Alzheimer's disease and other disorders is rapidly expanding due to&#xD;
      the aging of society and the longevity of citizens. In its varying stages, care of the&#xD;
      dementia syndrome requires differing sets of skills from the caregivers, and more skilled&#xD;
      intervention is required as the disease progresses. These caregivers experience increased&#xD;
      burden due to the challenges and stresses of caring. A recent systematic review of caregiver&#xD;
      burden factors revealed dementia-related agitation to be the most prevalent factor leading&#xD;
      caregivers to institutionalize community-dwelling loved ones with dementia. Tools that&#xD;
      empower caregivers to proactively reduce the incidents and severity of agitation would reduce&#xD;
      stress and increase self-efficacy, thereby extending aging-in-place and the associated&#xD;
      quality-of-life and cost benefits.&#xD;
&#xD;
      This project proposes to develop, deploy, and evaluate such a tool and to address the&#xD;
      fundamental scientific challenges to realizing the benefits of such a technology to&#xD;
      caregivers and persons with dementia (PWD). The tool - BESI: Behavioral and Environmental&#xD;
      Sensing and Intervention - will be an empowerment tool for caregivers of community-dwelling&#xD;
      PWD. BESI comprises:&#xD;
&#xD;
        1. a system of body-worn inertial sensors and in-home acoustic, light, temperature, and&#xD;
           motion sensors,&#xD;
&#xD;
        2. data analysis techniques to detect and assess agitation and environmental context from&#xD;
           these sensor streams,&#xD;
&#xD;
        3. models for the relationship between agitation and the environment that are trained for&#xD;
           each PWD-caregiver dyad based on a&amp;b, and&#xD;
&#xD;
        4. automated real-time notifications to the caregiver based on b&amp;c (e.g., detection of&#xD;
           early agitation stages or of an environment (cumulative and/or instantaneous based on&#xD;
           the models) that has led to agitation in the past), empowering the caregiver to&#xD;
           intervene before agitation escalation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improved Caregiver Self-Efficacy</measure>
    <time_frame>30 days</time_frame>
    <description>Increased scores on Revised Scale for Caregiver Self-Efficacy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decreased Caregiver Burden</measure>
    <time_frame>30 days</time_frame>
    <description>Zarit Burden Interview score lowered</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Behavioral and Psychiatric Symptoms of Dementia</condition>
  <condition>Dementia</condition>
  <condition>Caregivers</condition>
  <arm_group>
    <arm_group_label>Phase 1-Controlled Validation &amp; Study Planning</arm_group_label>
    <description>Phase 1 is focused on refining and ultimately verifying BESI's basic sensing and notification functionality and validating BESI's environmental assessments in a controlled setting - namely the laboratory and homes of two healthy volunteers. This phase also serves to support further requirements gathering to refine BESI for community-based deployment. No interventions are delivered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 - In-situ Validation and Ethnographic Analysis</arm_group_label>
    <description>Phase 2 starts the deployment of the technology within a community context, with the goals of validating the system's ability to assess agitation and environmental events in-situ and developing the cyber-sociophysical system models based on the dyad-specific relationship between agitation and the environment. A hybrid remote ethnographic methodology will be used, combining remote BESI measurement and caregiver diaries and a time-series design for the administration of the assessment battery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3 - Intervention with Home-Based Caregivers</arm_group_label>
    <description>Phase 3 is the intervention phase and the full realization of BESI. The goal is to employ the validated assessment capabilities and the developed modeling techniques to enable real-time, dyad-specific caregiver notifications that empower a caregiver to intervene with the PWD and/or environment before agitation escalation. In addition to validation of the BESI's ability to provide such appropriate notifications, Phase 3 will also serve as a pilot study about the effect that these notifications have on caregiver empowerment (as measured by self-efficacy) and the frequency and severity of PWD agitation, thus providing proof-of-concept for BESI's potential to improve dyad outcomes and motivating a larger-scale followup study to establish proof-of-practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention with Home-Based Caregivers</intervention_name>
    <description>We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.</description>
    <arm_group_label>Phase 3 - Intervention with Home-Based Caregivers</arm_group_label>
    <other_name>Real-time caregiver notifications</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample of people with dementia living at home with unpaid caregivers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of dementia&#xD;
&#xD;
          -  Living in one home for at least 2 months without hospitalization&#xD;
&#xD;
          -  Caregiver seeking support for caregiving needs&#xD;
&#xD;
          -  Have a stable caregiver&#xD;
&#xD;
          -  Be able to provide consent or assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitalization in the last 2 months&#xD;
&#xD;
          -  Multiple and inconsistent caregivers&#xD;
&#xD;
          -  Living in multiple homes&#xD;
&#xD;
          -  Unable to provide consent or assent&#xD;
&#xD;
          -  No known dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Lach, Ph.D</last_name>
      <email>jlach@virginia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Tonya Smith-Jackson, Ph.D</last_name>
      <email>tlsmithj@ncat.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Azziza Bankole, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martha Anderson, DNP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pebble.com</url>
    <description>Wearable device used in BESI</description>
  </link>
  <reference>
    <citation>Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.</citation>
    <PMID>27570871</PMID>
  </reference>
  <reference>
    <citation>Friedman EM, Shih RA, Langa KM, Hurd MD. US Prevalence And Predictors Of Informal Caregiving For Dementia. Health Aff (Millwood). 2015 Oct;34(10):1637-41. doi: 10.1377/hlthaff.2015.0510. Erratum In: Health Aff (Millwood). 2015 Nov;34(11):2006.</citation>
    <PMID>26438738</PMID>
  </reference>
  <reference>
    <citation>Cohen-Mansfield J, Billig N. Agitated behaviors in the elderly. I. A conceptual review. J Am Geriatr Soc. 1986 Oct;34(10):711-21. doi: 10.1111/j.1532-5415.1986.tb04302.x.</citation>
    <PMID>3531296</PMID>
  </reference>
  <reference>
    <citation>Cummings J, Mintzer J, Brodaty H, Sano M, Banerjee S, Devanand DP, Gauthier S, Howard R, Lanctot K, Lyketsos CG, Peskind E, Porsteinsson AP, Reich E, Sampaio C, Steffens D, Wortmann M, Zhong K; International Psychogeriatric Association. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015 Jan;27(1):7-17. doi: 10.1017/S1041610214001963. Epub 2014 Oct 14.</citation>
    <PMID>25311499</PMID>
  </reference>
  <reference>
    <citation>Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.</citation>
    <PMID>2715584</PMID>
  </reference>
  <reference>
    <citation>Colombo M, Vitali S, Cairati M, Vaccaro R, Andreoni G, Guaita A. Behavioral and psychotic symptoms of dementia (BPSD) improvements in a special care unit: a factor analysis. Arch Gerontol Geriatr. 2007;44 Suppl 1:113-20. doi: 10.1016/j.archger.2007.01.017.</citation>
    <PMID>17317443</PMID>
  </reference>
  <reference>
    <citation>Steinberg M, Shao H, Zandi P, Lyketsos CG, Welsh-Bohmer KA, Norton MC, Breitner JC, Steffens DC, Tschanz JT; Cache County Investigators. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. Int J Geriatr Psychiatry. 2008 Feb;23(2):170-7. doi: 10.1002/gps.1858.</citation>
    <PMID>17607801</PMID>
  </reference>
  <reference>
    <citation>Sansoni J, Anderson KH, Varona LM, Varela G. Caregivers of Alzheimer's patients and factors influencing institutionalization of loved ones: some considerations on existing literature. Ann Ig. 2013 May-Jun;25(3):235-46. doi: 10.7416/ai.2013.1926.</citation>
    <PMID>23598807</PMID>
  </reference>
  <reference>
    <citation>Fonareva I, Oken BS. Physiological and functional consequences of caregiving for relatives with dementia. Int Psychogeriatr. 2014 May;26(5):725-47. doi: 10.1017/S1041610214000039. Epub 2014 Feb 10.</citation>
    <PMID>24507463</PMID>
  </reference>
  <reference>
    <citation>Mausbach BT, Chattillion EA, Roepke SK, Patterson TL, Grant I. A comparison of psychosocial outcomes in elderly Alzheimer caregivers and noncaregivers. Am J Geriatr Psychiatry. 2013 Jan;21(1):5-13. doi: 10.1016/j.jagp.2012.10.001. Epub 2013 Jan 2.</citation>
    <PMID>23290198</PMID>
  </reference>
  <reference>
    <citation>Epstein-Lubow G, Gaudiano B, Darling E, Hinckley M, Tremont G, Kohn R, Marino LJ Jr, Salloway S, Grinnell R, Miller IW. Differences in depression severity in family caregivers of hospitalized individuals with dementia and family caregivers of outpatients with dementia. Am J Geriatr Psychiatry. 2012 Sep;20(9):815-9. doi: 10.1097/JGP.0b013e318235b62f.</citation>
    <PMID>21997604</PMID>
  </reference>
  <reference>
    <citation>Bankole A, Anderson M, Smith-Jackson T, Knight A, Oh K, Brantley J, Barth A, Lach J. Validation of noninvasive body sensor network technology in the detection of agitation in dementia. Am J Alzheimers Dis Other Demen. 2012 Aug;27(5):346-54. doi: 10.1177/1533317512452036.</citation>
    <PMID>22815084</PMID>
  </reference>
  <reference>
    <citation>Rowe M, Lane S, Phipps C. CareWatch: A Home Monitoring System for Use in Homes of Persons With Cognitive Impairment. Top Geriatr Rehabil. 2007 Jan 1;23(1):3-8. doi: 10.1097/00013614-200701000-00003.</citation>
    <PMID>20454554</PMID>
  </reference>
  <reference>
    <citation>Sacco G, Joumier V, Darmon N, Dechamps A, Derreumaux A, Lee JH, Piano J, Bordone N, Konig A, Teboul B, David R, Guerin O, Bremond F, Robert P. Detection of activities of daily living impairment in Alzheimer's disease and mild cognitive impairment using information and communication technology. Clin Interv Aging. 2012;7:539-49. doi: 10.2147/CIA.S36297. Epub 2012 Dec 4.</citation>
    <PMID>23271900</PMID>
  </reference>
  <reference>
    <citation>Perlman CM, Hirdes JP. The aggressive behavior scale: a new scale to measure aggression based on the minimum data set. J Am Geriatr Soc. 2008 Dec;56(12):2298-303. doi: 10.1111/j.1532-5415.2008.02048.x.</citation>
    <PMID>19093929</PMID>
  </reference>
  <reference>
    <citation>Hall GR, Gerdner LA, Zwygart-Stauffacher M, et al: Principles of nonpharmacological management: Caring for people with Alzheimer's disease using a conceptual model. Psychiatric Annals 1995; 25(7):432-440</citation>
  </reference>
  <reference>
    <citation>Smith M, Gerdner LA, Hall GR, Buckwalter KC. History, development, and future of the progressively lowered stress threshold: a conceptual model for dementia care. J Am Geriatr Soc. 2004 Oct;52(10):1755-60. doi: 10.1111/j.1532-5415.2004.52473.x.</citation>
    <PMID>15450057</PMID>
  </reference>
  <reference>
    <citation>Gerdner LA, Buckwalter KC, Hall GR: Temporal patterning of agitation and stressors associated with agitation: Case profiles to illustrate the Progressively Lowered Stress Threshold model. Journal of the American Psychiatric Nurses Association 2005; 11(4):215-222</citation>
  </reference>
  <reference>
    <citation>Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.</citation>
    <PMID>11001602</PMID>
  </reference>
  <reference>
    <citation>Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.</citation>
    <PMID>1504288</PMID>
  </reference>
  <reference>
    <citation>Teng EL, Chui HC. The Modified Mini-Mental State (3MS) examination. J Clin Psychiatry. 1987 Aug;48(8):314-8.</citation>
    <PMID>3611032</PMID>
  </reference>
  <reference>
    <citation>Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.</citation>
    <PMID>8232972</PMID>
  </reference>
  <reference>
    <citation>Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.</citation>
    <PMID>3337862</PMID>
  </reference>
  <reference>
    <citation>Orme JG, Reis J, Herz EJ. Factorial and discriminant validity of the Center for Epidemiological Studies Depression (CES-D) scale. J Clin Psychol. 1986 Jan;42(1):28-33. doi: 10.1002/1097-4679(198601)42:13.0.co;2-t.</citation>
    <PMID>3950011</PMID>
  </reference>
  <reference>
    <citation>Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.</citation>
    <PMID>11773226</PMID>
  </reference>
  <reference>
    <citation>Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.</citation>
    <PMID>11574710</PMID>
  </reference>
  <reference>
    <citation>MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.</citation>
    <PMID>14258950</PMID>
  </reference>
  <reference>
    <citation>Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (inter-rater agreement) of the Barthel Index for assessment of stroke survivors: systematic review and meta-analysis. Stroke. 2013 Feb;44(2):462-8. doi: 10.1161/STROKEAHA.112.678615. Epub 2013 Jan 8.</citation>
    <PMID>23299497</PMID>
  </reference>
  <reference>
    <citation>Logsdon RG, Gibbons LE, McCurry, et al: Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Ageing 1999; 5:21-32</citation>
  </reference>
  <reference>
    <citation>Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.</citation>
    <PMID>2748771</PMID>
  </reference>
  <reference>
    <citation>Grissom RJ. Heterogeneity of variance in clinical data. J Consult Clin Psychol. 2000 Feb;68(1):155-65. doi: 10.1037//0022-006x.68.1.155.</citation>
    <PMID>10710850</PMID>
  </reference>
  <reference>
    <citation>Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.</citation>
    <PMID>17679641</PMID>
  </reference>
  <reference>
    <citation>Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Apr 4;368(14):1326-34. doi: 10.1056/NEJMsa1204629.</citation>
    <PMID>23550670</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dementia Caregiver Empowerment</keyword>
  <keyword>Caregiver Burden</keyword>
  <keyword>Agitation in Dementia</keyword>
  <keyword>Environmental Sensors</keyword>
  <keyword>Wearable Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297268
org study id: 0037457000
secondary id: 1418622
nct id: NCT03297268
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This 3-phase research plan to employ Behavioral and Environmental Sensing and Intervention
      (BESI) will overcome the fundamental scientific barriers to realizing prediction of agitation
      episodes and detection early stages of dementia related agitation. The goal of which is
      empowering caregivers to intervene early and ultimately reduce agitation, thus reducing
      caregiver burden and extending aging-in-place and improving the associated quality-of-life
      and cost benefits.
The dementia syndrome of Alzheimer's disease and other disorders is rapidly expanding due to
      the aging of society and the longevity of citizens. In its varying stages, care of the
      dementia syndrome requires differing sets of skills from the caregivers, and more skilled
      intervention is required as the disease progresses. These caregivers experience increased
      burden due to the challenges and stresses of caring. A recent systematic review of caregiver
      burden factors revealed dementia-related agitation to be the most prevalent factor leading
      caregivers to institutionalize community-dwelling loved ones with dementia. Tools that
      empower caregivers to proactively reduce the incidents and severity of agitation would reduce
      stress and increase self-efficacy, thereby extending aging-in-place and the associated
      quality-of-life and cost benefits.

      This project proposes to develop, deploy, and evaluate such a tool and to address the
      fundamental scientific challenges to realizing the benefits of such a technology to
      caregivers and persons with dementia (PWD). The tool - BESI: Behavioral and Environmental
      Sensing and Intervention - will be an empowerment tool for caregivers of community-dwelling
      PWD. BESI comprises:

        1. a system of body-worn inertial sensors and in-home acoustic, light, temperature, and
           motion sensors,

        2. data analysis techniques to detect and assess agitation and environmental context from
           these sensor streams,

        3. models for the relationship between agitation and the environment that are trained for
           each PWD-caregiver dyad based on a&b, and

        4. automated real-time notifications to the caregiver based on b&c (e.g., detection of
           early agitation stages or of an environment (cumulative and/or instantaneous based on
           the models) that has led to agitation in the past), empowering the caregiver to
           intervene before agitation escalation.
observational model: Family-Based
time perspective: Cross-Sectional
measure: Improved Caregiver Self-Efficacy
time frame: 30 days
description: Increased scores on Revised Scale for Caregiver Self-Efficacy
measure: Decreased Caregiver Burden
time frame: 30 days
description: Zarit Burden Interview score lowered
arm group label: Phase 1-Controlled Validation & Study Planning
description: Phase 1 is focused on refining and ultimately verifying BESI's basic sensing and notification functionality and validating BESI's environmental assessments in a controlled setting - namely the laboratory and homes of two healthy volunteers. This phase also serves to support further requirements gathering to refine BESI for community-based deployment. No interventions are delivered.
arm group label: Phase 2 - In-situ Validation and Ethnographic Analysis
description: Phase 2 starts the deployment of the technology within a community context, with the goals of validating the system's ability to assess agitation and environmental events in-situ and developing the cyber-sociophysical system models based on the dyad-specific relationship between agitation and the environment. A hybrid remote ethnographic methodology will be used, combining remote BESI measurement and caregiver diaries and a time-series design for the administration of the assessment battery.
arm group label: Phase 3 - Intervention with Home-Based Caregivers
description: Phase 3 is the intervention phase and the full realization of BESI. The goal is to employ the validated assessment capabilities and the developed modeling techniques to enable real-time, dyad-specific caregiver notifications that empower a caregiver to intervene with the PWD and/or environment before agitation escalation. In addition to validation of the BESI's ability to provide such appropriate notifications, Phase 3 will also serve as a pilot study about the effect that these notifications have on caregiver empowerment (as measured by self-efficacy) and the frequency and severity of PWD agitation, thus providing proof-of-concept for BESI's potential to improve dyad outcomes and motivating a larger-scale followup study to establish proof-of-practice.
intervention type: Other
intervention name: Intervention with Home-Based Caregivers
description: We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.
arm group label: Phase 3 - Intervention with Home-Based Caregivers
other name: Real-time caregiver notifications
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
url: http://www.pebble.com
description: Wearable device used in BESI
citation: Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001.
PMID: 27570871
citation: Friedman EM, Shih RA, Langa KM, Hurd MD. US Prevalence And Predictors Of Informal Caregiving For Dementia. Health Aff (Millwood). 2015 Oct;34(10):1637-41. doi: 10.1377/hlthaff.2015.0510. Erratum In: Health Aff (Millwood). 2015 Nov;34(11):2006.
PMID: 26438738
citation: Cohen-Mansfield J, Billig N. Agitated behaviors in the elderly. I. A conceptual review. J Am Geriatr Soc. 1986 Oct;34(10):711-21. doi: 10.1111/j.1532-5415.1986.tb04302.x.
PMID: 3531296
citation: Cummings J, Mintzer J, Brodaty H, Sano M, Banerjee S, Devanand DP, Gauthier S, Howard R, Lanctot K, Lyketsos CG, Peskind E, Porsteinsson AP, Reich E, Sampaio C, Steffens D, Wortmann M, Zhong K; International Psychogeriatric Association. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015 Jan;27(1):7-17. doi: 10.1017/S1041610214001963. Epub 2014 Oct 14.
PMID: 25311499
citation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.
PMID: 2715584
citation: Colombo M, Vitali S, Cairati M, Vaccaro R, Andreoni G, Guaita A. Behavioral and psychotic symptoms of dementia (BPSD) improvements in a special care unit: a factor analysis. Arch Gerontol Geriatr. 2007;44 Suppl 1:113-20. doi: 10.1016/j.archger.2007.01.017.
PMID: 17317443
citation: Steinberg M, Shao H, Zandi P, Lyketsos CG, Welsh-Bohmer KA, Norton MC, Breitner JC, Steffens DC, Tschanz JT; Cache County Investigators. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. Int J Geriatr Psychiatry. 2008 Feb;23(2):170-7. doi: 10.1002/gps.1858.
PMID: 17607801
citation: Sansoni J, Anderson KH, Varona LM, Varela G. Caregivers of Alzheimer's patients and factors influencing institutionalization of loved ones: some considerations on existing literature. Ann Ig. 2013 May-Jun;25(3):235-46. doi: 10.7416/ai.2013.1926.
PMID: 23598807
citation: Fonareva I, Oken BS. Physiological and functional consequences of caregiving for relatives with dementia. Int Psychogeriatr. 2014 May;26(5):725-47. doi: 10.1017/S1041610214000039. Epub 2014 Feb 10.
PMID: 24507463
citation: Mausbach BT, Chattillion EA, Roepke SK, Patterson TL, Grant I. A comparison of psychosocial outcomes in elderly Alzheimer caregivers and noncaregivers. Am J Geriatr Psychiatry. 2013 Jan;21(1):5-13. doi: 10.1016/j.jagp.2012.10.001. Epub 2013 Jan 2.
PMID: 23290198
citation: Epstein-Lubow G, Gaudiano B, Darling E, Hinckley M, Tremont G, Kohn R, Marino LJ Jr, Salloway S, Grinnell R, Miller IW. Differences in depression severity in family caregivers of hospitalized individuals with dementia and family caregivers of outpatients with dementia. Am J Geriatr Psychiatry. 2012 Sep;20(9):815-9. doi: 10.1097/JGP.0b013e318235b62f.
PMID: 21997604
citation: Bankole A, Anderson M, Smith-Jackson T, Knight A, Oh K, Brantley J, Barth A, Lach J. Validation of noninvasive body sensor network technology in the detection of agitation in dementia. Am J Alzheimers Dis Other Demen. 2012 Aug;27(5):346-54. doi: 10.1177/1533317512452036.
PMID: 22815084
citation: Rowe M, Lane S, Phipps C. CareWatch: A Home Monitoring System for Use in Homes of Persons With Cognitive Impairment. Top Geriatr Rehabil. 2007 Jan 1;23(1):3-8. doi: 10.1097/00013614-200701000-00003.
PMID: 20454554
citation: Sacco G, Joumier V, Darmon N, Dechamps A, Derreumaux A, Lee JH, Piano J, Bordone N, Konig A, Teboul B, David R, Guerin O, Bremond F, Robert P. Detection of activities of daily living impairment in Alzheimer's disease and mild cognitive impairment using information and communication technology. Clin Interv Aging. 2012;7:539-49. doi: 10.2147/CIA.S36297. Epub 2012 Dec 4.
PMID: 23271900
citation: Perlman CM, Hirdes JP. The aggressive behavior scale: a new scale to measure aggression based on the minimum data set. J Am Geriatr Soc. 2008 Dec;56(12):2298-303. doi: 10.1111/j.1532-5415.2008.02048.x.
PMID: 19093929
citation: Hall GR, Gerdner LA, Zwygart-Stauffacher M, et al: Principles of nonpharmacological management: Caring for people with Alzheimer's disease using a conceptual model. Psychiatric Annals 1995; 25(7):432-440
citation: Smith M, Gerdner LA, Hall GR, Buckwalter KC. History, development, and future of the progressively lowered stress threshold: a conceptual model for dementia care. J Am Geriatr Soc. 2004 Oct;52(10):1755-60. doi: 10.1111/j.1532-5415.2004.52473.x.
PMID: 15450057
citation: Gerdner LA, Buckwalter KC, Hall GR: Temporal patterning of agitation and stressors associated with agitation: Case profiles to illustrate the Progressively Lowered Stress Threshold model. Journal of the American Psychiatric Nurses Association 2005; 11(4):215-222
citation: Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
PMID: 11001602
citation: Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int Psychogeriatr. 1992;4 Suppl 1:55-69. doi: 10.1017/s1041610292001157.
PMID: 1504288
citation: Teng EL, Chui HC. The Modified Mini-Mental State (3MS) examination. J Clin Psychiatry. 1987 Aug;48(8):314-8.
PMID: 3611032
citation: Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
PMID: 8232972
citation: Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
PMID: 3337862
citation: Orme JG, Reis J, Herz EJ. Factorial and discriminant validity of the Center for Epidemiological Studies Depression (CES-D) scale. J Clin Psychol. 1986 Jan;42(1):28-33. doi: 10.1002/1097-4679(198601)42:13.0.co;2-t.
PMID: 3950011
citation: Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.
PMID: 11773226
citation: Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
PMID: 11574710
citation: MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PMID: 14258950
citation: Duffy L, Gajree S, Langhorne P, Stott DJ, Quinn TJ. Reliability (inter-rater agreement) of the Barthel Index for assessment of stroke survivors: systematic review and meta-analysis. Stroke. 2013 Feb;44(2):462-8. doi: 10.1161/STROKEAHA.112.678615. Epub 2013 Jan 8.
PMID: 23299497
citation: Logsdon RG, Gibbons LE, McCurry, et al: Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Ageing 1999; 5:21-32
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PMID: 2748771
citation: Grissom RJ. Heterogeneity of variance in clinical data. J Consult Clin Psychol. 2000 Feb;68(1):155-65. doi: 10.1037//0022-006x.68.1.155.
PMID: 10710850
citation: Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
PMID: 17679641
citation: Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Apr 4;368(14):1326-34. doi: 10.1056/NEJMsa1204629.
PMID: 23550670
responsible party type: Sponsor
mesh term: Dementia
mesh term: Alzheimer Disease
sharing ipd: No