<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/NCT02224430</url>
  </required_header>
  <id_info>
    <org_study_id>OBSERVESCH4001</org_study_id>
    <nct_id>NCT02224430</nct_id>
  </id_info>
  <brief_title>Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors</brief_title>
  <official_title>Remote Physiological, Behavioral and Symptom Assessment Study to Identify Predictors of Symptom Exacerbation and Relapse in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is dedicated to achieving a better understanding of how to identify patterns that&#xD;
      indicate someone might be at high risk for relapse in schizophrenia or schizoaffective&#xD;
      disorder. The investigators are utilizing smartphone technology along with on body sensors to&#xD;
      achieve this goal. The study will observe participants behavior in their natural environment&#xD;
      for a period of 16 weeks or until a signal of relapse is obtained. Participants will also&#xD;
      complete scales in a clinical research environment biweekly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will follow a group of participants who have recently been discharged from the&#xD;
      emergency room or the hospital using several new &quot;high-tech&quot; methods, including the use of a&#xD;
      smartphone, health and wellness wristbands/watches and an optional arm patch sensor. These&#xD;
      devices (some of which are commercially available to the public for purchase), will capture&#xD;
      ongoing physiological information including sweat gland activity, movement, skin temperature,&#xD;
      heart rate, breathing rate, and sleep. The smart phone, and an installed application, will&#xD;
      administer bidaily and weekly symptom assessment, track the general location of the&#xD;
      participant, and collect statistics about text messaging and cell phone use.&#xD;
&#xD;
      In addition to the on-body devices participants will come into the clinical research office&#xD;
      to complete clinical scales every other week. These scales will be used to determine symptom&#xD;
      exacerbation or relapse. This signature will then be utilized as a marker to examine the data&#xD;
      collected from the devices.&#xD;
&#xD;
      The investigators hope to go beyond clinical evaluation and identify a signature of relapse&#xD;
      that is reliably detected from on body devices in a natural setting. This would cut down on&#xD;
      the time it takes to successfully treat psychotic illnesses and would reduce the amount of&#xD;
      pain and and suffering experienced by patients during relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse or exacerbation of symptoms in schizophrenia/schizoaffective disorder</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>To determine patterns of risk for relapse appropriate model will be used considering factors such as, but not limited to, medication compliance, accelerometry / physical activity, skin temperature, continuity of sleep, duration of sleep, engagement with others through text and talk, changes in geographic range, daily questionnaire responses, cognitive symptom, impulsivity and psychosocial functioning scales.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>schizophrenia/schizoaffective disorder</arm_group_label>
    <description>Participants with schizophrenia/schizoaffective disorder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>schizophrenia/schizoaffective disorder.</intervention_name>
    <description>Participants with schizophrenia/schizoaffective disorder will be observed remotely and at weekly/biweekly laboratory visits over a period of 16 weeks or until relapse occurs.</description>
    <arm_group_label>schizophrenia/schizoaffective disorder</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        schizophrenia/schizoaffective disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM - 5 criteria for schizophrenia or schizoaffective disorder based on Diagnostic and&#xD;
             Statistical Manual (DSM) criteria&#xD;
&#xD;
          -  Males and females 19 years or older&#xD;
&#xD;
          -  Discharged from the University of Alabama at Birmingham (UAB) inpatient psychiatric&#xD;
             unit or the emergency department (ER) or currently seen by UAB outpatient physicians&#xD;
&#xD;
          -  Prescribed and maintained on antipsychotic medication&#xD;
&#xD;
          -  Psychiatrically stable for a period of at least two weeks&#xD;
&#xD;
          -  Willingness and capability to comply with the study procedures, including responding&#xD;
             to smartphone application prompts, wearing the optional on-body electronic devices&#xD;
&#xD;
          -  Each participant must activate the Ginger.io User License Agreement (ULA) indicating&#xD;
             that he or she understands how data security will be maintained on the smartphones.&#xD;
&#xD;
          -  Each participant must sign an Informed Consent (ICF) indicating that he or she&#xD;
             understands the purpose of the procedures required for the study and are willing to&#xD;
             participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical and or clinical disabilities such as hearing, vision, or motor impairment,&#xD;
             which make it impossible to operate a smartphone or respond to prompts (determined&#xD;
             using demonstration smartphone for screening)&#xD;
&#xD;
          -  Inability to understand the consent process as determined by the Evaluation to Give&#xD;
             Consent&#xD;
&#xD;
          -  Substance Use Disorder rating of severe (6 or more symptoms) according to the DSM-5&#xD;
&#xD;
          -  Participants with any known skin allergy to the use of adhesives and/or lithium will&#xD;
             be excluded from the optional Metria patch segment of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrienne C Lahti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>July 23, 2021</last_update_submitted>
  <last_update_submitted_qc>July 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Dr. Adrianne C Lahti</investigator_full_name>
    <investigator_title>Patrick H. Linton Professor and Director of the Division of Behavioral Neurobiology</investigator_title>
  </responsible_party>
  <keyword>biomarker of relapse</keyword>
  <keyword>schizophrenia</keyword>
  <keyword>schizoaffective disorder</keyword>
  <keyword>on-body sensors</keyword>
  <keyword>smartphone</keyword>
  <keyword>observational</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02224430
org study id: OBSERVESCH4001
nct id: NCT02224430
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study is dedicated to achieving a better understanding of how to identify patterns that
      indicate someone might be at high risk for relapse in schizophrenia or schizoaffective
      disorder. The investigators are utilizing smartphone technology along with on body sensors to
      achieve this goal. The study will observe participants behavior in their natural environment
      for a period of 16 weeks or until a signal of relapse is obtained. Participants will also
      complete scales in a clinical research environment biweekly.
This study will follow a group of participants who have recently been discharged from the
      emergency room or the hospital using several new "high-tech" methods, including the use of a
      smartphone, health and wellness wristbands/watches and an optional arm patch sensor. These
      devices (some of which are commercially available to the public for purchase), will capture
      ongoing physiological information including sweat gland activity, movement, skin temperature,
      heart rate, breathing rate, and sleep. The smart phone, and an installed application, will
      administer bidaily and weekly symptom assessment, track the general location of the
      participant, and collect statistics about text messaging and cell phone use.

      In addition to the on-body devices participants will come into the clinical research office
      to complete clinical scales every other week. These scales will be used to determine symptom
      exacerbation or relapse. This signature will then be utilized as a marker to examine the data
      collected from the devices.

      The investigators hope to go beyond clinical evaluation and identify a signature of relapse
      that is reliably detected from on body devices in a natural setting. This would cut down on
      the time it takes to successfully treat psychotic illnesses and would reduce the amount of
      pain and and suffering experienced by patients during relapse.
observational model: Ecologic or Community
time perspective: Other
measure: Relapse or exacerbation of symptoms in schizophrenia/schizoaffective disorder
time frame: up to 16 weeks
description: To determine patterns of risk for relapse appropriate model will be used considering factors such as, but not limited to, medication compliance, accelerometry / physical activity, skin temperature, continuity of sleep, duration of sleep, engagement with others through text and talk, changes in geographic range, daily questionnaire responses, cognitive symptom, impulsivity and psychosocial functioning scales.
arm group label: schizophrenia/schizoaffective disorder
description: Participants with schizophrenia/schizoaffective disorder.
intervention type: Device
intervention name: schizophrenia/schizoaffective disorder.
description: Participants with schizophrenia/schizoaffective disorder will be observed remotely and at weekly/biweekly laboratory visits over a period of 16 weeks or until relapse occurs.
arm group label: schizophrenia/schizoaffective disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: No
last name: Adrienne C Lahti, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Dr. Adrianne C Lahti
investigator title: Patrick H. Linton Professor and Director of the Division of Behavioral Neurobiology
mesh term: Recurrence
mesh term: Schizophrenia
mesh term: Psychotic Disorders
sharing ipd: Undecided