xml: <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/NCT05973448</url>
    </required_header>
    <id_info>
      <org_study_id>22-1162</org_study_id>
      <secondary_id>1R01AG075010-01</secondary_id>
      <nct_id>NCT05973448</nct_id>
    </id_info>
    <brief_title>The Nightlight Falls Prevention Study</brief_title>
    <official_title>A Pragmatic Crossover Trial to Test the Effectiveness of a Novel Lighting System to Reduce Nighttime Falls in Persons With Alzheimer's Disease and Related Dementias</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</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 project will test the effectiveness of a novel intervention consisting of unobtrusive,&#xD;
        low-intensity, horizontal and vertical lights that outline the bathroom or entry way&#xD;
        doorframe in residents' rooms and provide visual cues to promote postural stability.&#xD;
        Specifically, this pragmatic crossover trial will enroll 390 assisted living residents with&#xD;
        dementia and follow them for one year, comparing the incidence of nighttime falls during the&#xD;
        lighting condition to the incidence of falls during the control condition; secondarily, it&#xD;
        will determine whether and to what extent the intervention effect is modified by resident-&#xD;
        and environmental-level risk factors, and satisfaction with the lighting system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Falls are the primary cause of fatal and non-fatal injuries among persons 65 years of age and&#xD;
        older. Dementia is a major risk factors for falls, and assisted living (AL) communities are&#xD;
        the primary provider of residential care for ambulatory older adults with dementia, making AL&#xD;
        a critical setting in which to reduce falls. Forty-two percent of the more than 811,000 AL&#xD;
        residents across the U.S. have moderate or severe dementia, 84% are ambulatory, and more than&#xD;
        a third experience a fall in a six-month period, putting them among the 15% of AL residents&#xD;
        who suffer a hip fracture or other serious fall-related injury each year. Falls are&#xD;
        responsible for one-third of all hospitalizations of AL residents, and the resulting injuries&#xD;
        may lead to a cascade of events, including worsening function, nursing home transfer, and&#xD;
        death.&#xD;
  &#xD;
        A significant number of these falls occur in the bedroom during the evening and night, when&#xD;
        AL staff are not present, thereby limiting their ability to intervene. However, the cause of&#xD;
        many of these falls -- impaired nighttime vision and related postural instability -- suggests&#xD;
        a promising avenue for intervention.&#xD;
  &#xD;
        This project will test the effectiveness of a novel intervention consisting of unobtrusive,&#xD;
        low-intensity, horizontal and vertical lights that outline the bathroom or entry way&#xD;
        doorframe in residents' rooms and provide visual cues to promote postural stability. The&#xD;
        lighting system is particularly attractive and pragmatic because it is low cost, requires no&#xD;
        staff involvement, and can be easily installed in new buildings or retrofitted to existing&#xD;
        buildings.&#xD;
  &#xD;
        The study investigators recently completed a NIH R21 exploratory/developmental randomized&#xD;
        crossover trial of this system and found a 34% decrease in falls due to a novel lighting&#xD;
        intervention. This NIH R01 project will build on that preliminary effort; if the results are&#xD;
        as promising as suggested, this pragmatic passive lighting system has the potential to reduce&#xD;
        falls and related sequelae for countless persons with Alzheimer's disease and related&#xD;
        dementias, and to become a new standard of care.&#xD;
  &#xD;
        The intervention being tested is the effectiveness of a novel intervention consisting of&#xD;
        unobtrusive, low-intensity, horizontal and vertical lights that outline the bathroom or entry&#xD;
        way doorframe in assisted living (AL) residents' rooms in preventing night time falls. The&#xD;
        trial will enroll 390 AL residents with Alzheimer's disease and related dementias (ADRD) from&#xD;
        42 assisted living communities. The lighting will be installed in the rooms of all 390&#xD;
        enrolled AL residents and compared to standard nightlights (control condition). Using a&#xD;
        randomized crossover trial design, subjects will be examined under both conditions over one&#xD;
        year. The trial will enroll 14 communities per year for each of three years. Falls will be&#xD;
        measured using SafelyYou, a fall detection system that uses video cameras and artificial&#xD;
        intelligence to detect falls in resident rooms while maintaining resident privacy.&quot;&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Each participating community will have approximately 8-12 enrolled residents with ADRD. The AL communities will be randomized to four treatment sequences over the course of one year that define the order of the lighting intervention delivered across four 3-month (90 day) periods (N=390 residents). This design requires that the lights be turned on or off some periods, which will be done by research staff during scheduled visits. The four treatment sequences are chosen such that each resident receives control (C) lighting in two periods and novel lighting (L) in two periods and no more than 2 lighting changes. The four sequences are: CCLL, CLLC, LCCL, LLCC. There are no &quot;washout&quot; periods between the lighting conditions.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Falls incidence density ratio</measure>
      <time_frame>At study completion (one year)</time_frame>
      <description>(Number of falls/Number of Nights Novel) / (Number of falls/Number of Nights Control)</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">390</enrollment>
    <condition>Aging</condition>
    <condition>Alzheimer Disease</condition>
    <condition>Dementia Alzheimers</condition>
    <condition>Dementia of Alzheimer Type</condition>
    <condition>Fall Injury</condition>
    <arm_group>
      <arm_group_label>Lighting Sequence 1: CCLL</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this arm, the participant will receive the control lighting condition (C) for the first two quarters (180 days) and then crossover to the novel lighting condition (L) for the last two quarters (180 days).&#xD;
  Q1 - Control lighting Q2 - Control lighting Q3 - Novel lighting Q4 - Novel lighting</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lighting Sequence 2: CLLC</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this arm, the participant will receive the control lighting condition (C) for the first quarter (90 days) and then crossover to the novel lighting condition (L) for the next two quarters (180 days) and finally crossover again to the control condition (C) for the last quarter (90 days).&#xD;
  Q1 - Control lighting Q2 - Novel lighting Q3 - Novel lighting Q4 - Control lighting</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lighting Sequence 3: LCCL</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this arm, the participant will receive the novel lighting condition (L) for the first quarter (90 days) and then crossover to the control lighting condition (C) for the next two quarters (180 days) and finally crossover again to the novel condition (L) for the last quarter (90 days).&#xD;
  Q1 - Novel lighting Q2 - Control lighting Q3 - Control lighting Q4 - Novel lighting</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lighting Sequence 4: LLCC</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this arm, the participant will receive the novel lighting condition (L) for the first two quarters (180 days) and then crossover to the control lighting condition (C) for the last two quarters (180 days).&#xD;
  Q1 - Novel lighting Q2 - Novel lighting Q3 - Control lighting Q4 - Control lighting</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Novel Lighting Condition</intervention_name>
      <description>Horizontal and vertical lights over a doorway visible from the bed</description>
      <arm_group_label>Lighting Sequence 1: CCLL</arm_group_label>
      <arm_group_label>Lighting Sequence 2: CLLC</arm_group_label>
      <arm_group_label>Lighting Sequence 3: LCCL</arm_group_label>
      <arm_group_label>Lighting Sequence 4: LLCC</arm_group_label>
      <other_name>Indicated in sequence by &quot;L&quot;</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Lighting Condition</intervention_name>
      <description>Standard night light plugged into wall socket</description>
      <arm_group_label>Lighting Sequence 1: CCLL</arm_group_label>
      <arm_group_label>Lighting Sequence 2: CLLC</arm_group_label>
      <arm_group_label>Lighting Sequence 3: LCCL</arm_group_label>
      <arm_group_label>Lighting Sequence 4: LLCC</arm_group_label>
      <other_name>Indicated in sequence by &quot;C&quot;</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has a diagnosis of dementia&#xD;
  &#xD;
            -  Lives in a participating AL community&#xD;
  &#xD;
            -  Attempts to get out of bed&#xD;
  &#xD;
            -  Not wheelchair bound&#xD;
  &#xD;
            -  Not blind&#xD;
  &#xD;
            -  Not on hospice&#xD;
  &#xD;
            -  Not expected to die or transfer during the year of the study&#xD;
  &#xD;
            -  Does not share a bedroom (but may share a bathroom). Exception: roommates of different&#xD;
               genders may participate because they can be differentiated on the video.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheryl Zimmerman, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lynne A Sampson, PhD, MPH</last_name>
      <phone>(919) 843-7811</phone>
      <email>LSampson@email.unc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Johanna S Hickey, MSW</last_name>
      <phone>(919) 843-3085</phone>
      <email>jvtsilbersack@unc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Aging</keyword>
    <keyword>Alzheimer's Disease</keyword>
    <keyword>Alzheimer's Disease Related Dementias</keyword>
    <keyword>Assisted Living</keyword>
    <keyword>Fall Injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>With the exception of the falls video clips, all other individual participant data collected during the trial will be shared after deidentification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.</ipd_time_frame>
      <ipd_access_criteria>An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973448
  org study id: 22-1162
  secondary id: 1R01AG075010-01
  nct id: NCT05973448
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This project will test the effectiveness of a novel intervention consisting of unobtrusive,
        low-intensity, horizontal and vertical lights that outline the bathroom or entry way
        doorframe in residents' rooms and provide visual cues to promote postural stability.
        Specifically, this pragmatic crossover trial will enroll 390 assisted living residents with
        dementia and follow them for one year, comparing the incidence of nighttime falls during the
        lighting condition to the incidence of falls during the control condition; secondarily, it
        will determine whether and to what extent the intervention effect is modified by resident-
        and environmental-level risk factors, and satisfaction with the lighting system.
  Falls are the primary cause of fatal and non-fatal injuries among persons 65 years of age and
        older. Dementia is a major risk factors for falls, and assisted living (AL) communities are
        the primary provider of residential care for ambulatory older adults with dementia, making AL
        a critical setting in which to reduce falls. Forty-two percent of the more than 811,000 AL
        residents across the U.S. have moderate or severe dementia, 84% are ambulatory, and more than
        a third experience a fall in a six-month period, putting them among the 15% of AL residents
        who suffer a hip fracture or other serious fall-related injury each year. Falls are
        responsible for one-third of all hospitalizations of AL residents, and the resulting injuries
        may lead to a cascade of events, including worsening function, nursing home transfer, and
        death.
  
        A significant number of these falls occur in the bedroom during the evening and night, when
        AL staff are not present, thereby limiting their ability to intervene. However, the cause of
        many of these falls -- impaired nighttime vision and related postural instability -- suggests
        a promising avenue for intervention.
  
        This project will test the effectiveness of a novel intervention consisting of unobtrusive,
        low-intensity, horizontal and vertical lights that outline the bathroom or entry way
        doorframe in residents' rooms and provide visual cues to promote postural stability. The
        lighting system is particularly attractive and pragmatic because it is low cost, requires no
        staff involvement, and can be easily installed in new buildings or retrofitted to existing
        buildings.
  
        The study investigators recently completed a NIH R21 exploratory/developmental randomized
        crossover trial of this system and found a 34% decrease in falls due to a novel lighting
        intervention. This NIH R01 project will build on that preliminary effort; if the results are
        as promising as suggested, this pragmatic passive lighting system has the potential to reduce
        falls and related sequelae for countless persons with Alzheimer's disease and related
        dementias, and to become a new standard of care.
  
        The intervention being tested is the effectiveness of a novel intervention consisting of
        unobtrusive, low-intensity, horizontal and vertical lights that outline the bathroom or entry
        way doorframe in assisted living (AL) residents' rooms in preventing night time falls. The
        trial will enroll 390 AL residents with Alzheimer's disease and related dementias (ADRD) from
        42 assisted living communities. The lighting will be installed in the rooms of all 390
        enrolled AL residents and compared to standard nightlights (control condition). Using a
        randomized crossover trial design, subjects will be examined under both conditions over one
        year. The trial will enroll 14 communities per year for each of three years. Falls will be
        measured using SafelyYou, a fall detection system that uses video cameras and artificial
        intelligence to detect falls in resident rooms while maintaining resident privacy."
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Each participating community will have approximately 8-12 enrolled residents with ADRD. The AL communities will be randomized to four treatment sequences over the course of one year that define the order of the lighting intervention delivered across four 3-month (90 day) periods (N=390 residents). This design requires that the lights be turned on or off some periods, which will be done by research staff during scheduled visits. The four treatment sequences are chosen such that each resident receives control (C) lighting in two periods and novel lighting (L) in two periods and no more than 2 lighting changes. The four sequences are: CCLL, CLLC, LCCL, LLCC. There are no "washout" periods between the lighting conditions.
  primary purpose: Health Services Research
  masking: Single (Investigator)
  measure: Falls incidence density ratio
  time frame: At study completion (one year)
  description: (Number of falls/Number of Nights Novel) / (Number of falls/Number of Nights Control)
  arm group label: Lighting Sequence 1: CCLL
  arm group type: Other
  description: In this arm, the participant will receive the control lighting condition (C) for the first two quarters (180 days) and then crossover to the novel lighting condition (L) for the last two quarters (180 days).
  Q1 - Control lighting Q2 - Control lighting Q3 - Novel lighting Q4 - Novel lighting
  arm group label: Lighting Sequence 2: CLLC
  arm group type: Other
  description: In this arm, the participant will receive the control lighting condition (C) for the first quarter (90 days) and then crossover to the novel lighting condition (L) for the next two quarters (180 days) and finally crossover again to the control condition (C) for the last quarter (90 days).
  Q1 - Control lighting Q2 - Novel lighting Q3 - Novel lighting Q4 - Control lighting
  arm group label: Lighting Sequence 3: LCCL
  arm group type: Other
  description: In this arm, the participant will receive the novel lighting condition (L) for the first quarter (90 days) and then crossover to the control lighting condition (C) for the next two quarters (180 days) and finally crossover again to the novel condition (L) for the last quarter (90 days).
  Q1 - Novel lighting Q2 - Control lighting Q3 - Control lighting Q4 - Novel lighting
  arm group label: Lighting Sequence 4: LLCC
  arm group type: Other
  description: In this arm, the participant will receive the novel lighting condition (L) for the first two quarters (180 days) and then crossover to the control lighting condition (C) for the last two quarters (180 days).
  Q1 - Novel lighting Q2 - Novel lighting Q3 - Control lighting Q4 - Control lighting
  intervention type: Other
  intervention name: Novel Lighting Condition
  description: Horizontal and vertical lights over a doorway visible from the bed
  arm group label: Lighting Sequence 1: CCLL
  arm group label: Lighting Sequence 2: CLLC
  arm group label: Lighting Sequence 3: LCCL
  arm group label: Lighting Sequence 4: LLCC
  other name: Indicated in sequence by "L"
  intervention type: Other
  intervention name: Control Lighting Condition
  description: Standard night light plugged into wall socket
  arm group label: Lighting Sequence 1: CCLL
  arm group label: Lighting Sequence 2: CLLC
  arm group label: Lighting Sequence 3: LCCL
  arm group label: Lighting Sequence 4: LLCC
  other name: Indicated in sequence by "C"
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sheryl Zimmerman, PhD
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Lynne A Sampson, PhD, MPH
  phone: (919) 843-7811
  email: LSampson@email.unc.edu
  last name: Johanna S Hickey, MSW
  phone: (919) 843-3085
  email: jvtsilbersack@unc.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Dementia
  sharing ipd: Yes
  ipd description: With the exception of the falls video clips, all other individual participant data collected during the trial will be shared after deidentification.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
  ipd access criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.