<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/NCT03303456</url>
  </required_header>
  <id_info>
    <org_study_id>563584</org_study_id>
    <nct_id>NCT03303456</nct_id>
  </id_info>
  <brief_title>Using Mobile Technology to Enhance Early Psychosis Treatment Delivery</brief_title>
  <acronym>RWJFGinger</acronym>
  <official_title>Using Mobile Technology To Detect Early Warning Signs of Mental Health Challenges and Enhance Treatment Delivery For Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ginger.io</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</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 project tests the feasibility of implementing a smartphone application - Ginger.io - in&#xD;
      the UC Davis Early Psychosis Program, and investigates whether mobile health technology can&#xD;
      improve treatment delivery and outcomes in individuals with early psychosis. Ginger.io is a&#xD;
      smartphone application that utilizes methods of passive data collection (i.e. data gathered&#xD;
      without active interaction/contribution from the user) to gather communication, movement, and&#xD;
      interaction data from smartphone devices to model individuals' social, physical, and mental&#xD;
      health. These models are used to infer health-related outcomes and could inform treatment. By&#xD;
      implementing the Ginger.io application in the UC Davis Early Psychosis Program with an&#xD;
      integrated clinical and research infrastructure, the investigators will be able to quickly&#xD;
      determine its feasibility for use in early psychosis populations, while simultaneously&#xD;
      developing its ability to systematically capture aspects of relapse and recovery that are&#xD;
      unique to this patient population.&#xD;
&#xD;
      Objectives: This project has three principle objectives related to early psychosis care: 1)&#xD;
      improve treatment delivery, 2) improve patient outcomes, and 3) lower treatment costs. The&#xD;
      project will target individuals in the early stages of psychotic illness, including&#xD;
      individuals at high risk for developing a psychotic illness (termed &quot;clinical high risk&quot; or&#xD;
      CHR) and individuals within three years of their first psychotic episode (termed &quot;first&#xD;
      episode psychosis&quot; or FEP). The early stages of psychotic illness represent a critical period&#xD;
      for intervention; early identification of clinical deterioration and subsequent targeted&#xD;
      intervention is crucial for rapid remission of symptoms and reduced relapse rates. However,&#xD;
      without the information necessary to identify patients in need of such intervention,&#xD;
      providers are limited in their ability to respond rapidly. Within the UCD Early Psychosis&#xD;
      Program, a mobile health application such as Ginger.io has the potential to equip the&#xD;
      providers and caregivers with valuable insight into a patient's status in real-time without&#xD;
      the burden of increased appointments and intrusive monitoring, allowing the identification of&#xD;
      early psychosis patients most in need of outreach, and routing of treatment resources to the&#xD;
      right patients at the right time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project comprises two phases. In both phases, patients will use the Ginger.io app on&#xD;
      their mobile device to complete daily surveys assessing mood and social interactions, and&#xD;
      weekly surveys assessing symptoms. Patients will also complete monthly gold-standard clinical&#xD;
      interviews at the UC Davis Early Psychosis Program. Once enrolled, the investigators will ask&#xD;
      patients to participate for the duration of the study, a total of 14 months across Phase I&#xD;
      and II.&#xD;
&#xD;
      Phase I involves the collection of pilot data to assess feasibility and conduct exploratory&#xD;
      analyses. Participants will include individuals in the earliest stages of psychosis (CHR and&#xD;
      FEP). The investigators will recruit 60 participants to allow for 15% dropout, aiming to&#xD;
      obtain complete data on 50 participants. Given the emphasis on feasibility and acceptability&#xD;
      in Phase I, research staff will monitor patient Dashboards daily and provide clinicians with&#xD;
      weekly summaries for each patient. Clinicians and patients will provide ratings on&#xD;
      satisfaction and effect of Ginger.io on treatment at the end of Phase I.&#xD;
&#xD;
      Specific aims for Phase I are as follows:&#xD;
&#xD;
      Specific Aim 1: Determine the feasibility and acceptability of Ginger.io in an early&#xD;
      psychosis population.&#xD;
&#xD;
      Feasibility will be measured by utilization of the application (i.e. number of enrolled and&#xD;
      active participants versus total patient population invited). Acceptability will be measured&#xD;
      with satisfaction survey ratings of Ginger.io by patients and clinicians. Analysis will&#xD;
      include summary statistics reporting utilization rates and satisfaction ratings. The&#xD;
      investigators hypothesize high utilization of Ginger.io and low dropout, as well as high&#xD;
      satisfaction and endorsement of continued use of Ginger.io.&#xD;
&#xD;
      Specific Aim 2: Identify passive behavior data associated with gold-standard measures of&#xD;
      clinical symptoms and social functioning.&#xD;
&#xD;
      The investigators will examine associations between passive and active data collected via&#xD;
      Ginger.io. The investigators will then validate both the active and passive behavior data by&#xD;
      examining associations with symptom and social functioning ratings obtained via gold-standard&#xD;
      clinical interviews conducted at monthly research evaluations. The investigators hypothesize&#xD;
      patients' passive interaction data will positively associate with active survey data of&#xD;
      symptoms and social interactions (e.g. increase reports of mood will relate to more&#xD;
      texts/calls), and that both active and passive data regarding symptoms and social behavior&#xD;
      will relate to gold-standard clinical measures of symptoms and social functioning.&#xD;
&#xD;
      Specific Aim 3: Identify Ginger.io data related to key patient outcomes to inform calibration&#xD;
      of patient status alerts.&#xD;
&#xD;
      Exploratory analyses using regression models and repeated measure GLMs will examine whether&#xD;
      the passive and active data from Ginger.io statistically predict key patient outcomes,&#xD;
      including psychotic symptom flares, increased clinic contact, psychiatric ER visits or&#xD;
      hospitalizations, and progression from a high risk state to first episode psychosis. The&#xD;
      investigators hypothesize reductions in phone calls/text messages and/or increases in&#xD;
      self-reported ratings of basic symptoms will predict psychotic symptom flares, increased&#xD;
      clinic utilization, psychiatric ER visits and hospitalizations. This analysis will be used to&#xD;
      calibrate patient status alerts for Phase II that will notify clinicians which patients are&#xD;
      at risk of symptom exacerbation and relapse.&#xD;
&#xD;
      Specific Aim 4: Evaluate effect of Ginger.io on key treatment variables. Key variables of&#xD;
      interest are medication adherence, therapeutic alliance, and insight. All three variables&#xD;
      will be measured using self-report questionnaires (see Procedures Involved) administered to&#xD;
      patients at the beginning and end of the project, and as part of the monthly clinical&#xD;
      interviews, enabling the evaluation of change over time. The investigators hypothesize that,&#xD;
      following three months of Ginger.io use, patients will report improved medication adherence,&#xD;
      therapeutic alliance, and insight into their illness.&#xD;
&#xD;
      Phase II will extend the findings of Phase I through the implementation of Ginger.io in the&#xD;
      UC Davis Early Psychosis Programs (EDAPT and SacEDAPT) to allow clinicians to directly&#xD;
      interact with the Dashboard and integrate its information directly into patient care.&#xD;
      Patients will continue to complete daily and weekly surveys via Ginger.io, and monthly&#xD;
      clinical assessments with research staff. Additionally, clinicians will monitor patient&#xD;
      Dashboards on a daily basis and will respond to patient status alerts as they arise (see Aim&#xD;
      2 below). Phase I participants will be asked to remain in the study through Phase II,&#xD;
      yielding a more comprehensive longitudinal dataset. Phase II will involve a total of 120&#xD;
      participants (combined Phase I and newly recruited participants) to account for 15% dropout,&#xD;
      aiming to obtain data for at least 100 participants.&#xD;
&#xD;
      Phase II has four specific aims.&#xD;
&#xD;
      Specific Aim 1: Continue to validate predictive value of Ginger.io data related to key&#xD;
      patient outcomes.&#xD;
&#xD;
      This is a direct extension of Aim 3 in Phase I and will be addressed through continued linear&#xD;
      modeling of passive and active data from Ginger.io to identify and test statistical&#xD;
      predictors of key patient outcomes. This will facilitate continued calibration of patient&#xD;
      status alerts used in the Dashboard to notify clinicians when patients are at risk of&#xD;
      clinical deterioration.&#xD;
&#xD;
      Specific Aim 2: Evaluate effect of patient status alerts on treatment delivery. Key variables&#xD;
      of interest include clinician-rated utility of the patient status alerts, clinician choice of&#xD;
      treatment delivery following an alert, and the action response time following notification of&#xD;
      an alert. In response to each alert, clinicians will indicate the type of clinical&#xD;
      intervention they pursued (e.g. &quot;called patient to check in&quot;, &quot;scheduled appointment with&#xD;
      psychiatrist&quot;). All treatment will be clinician-driven and provided in a naturalistic manner,&#xD;
      and data will be collected on the types of treatments chosen for a given alert. Clinicians&#xD;
      will also rate the utility (e.g. not useful/useful) of the alert based on information&#xD;
      gathered during follow-up. Action response time will be recorded via Dashboard interaction.&#xD;
      Preliminary analyses will be exploratory and will inform continued improvements to the&#xD;
      Dashboard and calibration of patient status alerts. Summary statistics regarding clinician&#xD;
      responses, average response time, and utility ratings will be included. The investigators&#xD;
      hypothesize that clinicians will rate patient status alerts as useful and informative to&#xD;
      their treatment planning and intervention.&#xD;
&#xD;
      Specific Aim 3: Analysis of the impact of Ginger.io on cost of care. Key variables of&#xD;
      interest include cost of outpatient care, and psychiatric ER visits and hospitalizations. To&#xD;
      evaluate the impact of Ginger.io, the historical average monthly and annual cost of care per&#xD;
      patient will be compared to the average monthly and annual cost of care during and following&#xD;
      completion of the project. The investigators hypothesize that implementation of Ginger.io&#xD;
      will reduce the number and duration of psychiatric ER visits and hospitalizations, thereby&#xD;
      reducing costs.&#xD;
&#xD;
      Specific Aim 4: Continued evaluation of feasibility and acceptability of Ginger.io in an&#xD;
      early psychosis population.&#xD;
&#xD;
      The investigators will continue to evaluate feasibility and acceptability of Ginger.io in&#xD;
      both patients and clinicians using satisfaction surveys. The investigators hypothesize that&#xD;
      patients will continue to endorse high satisfaction rates and continued use of Ginger.io.&#xD;
      Additionally, the investigators hypothesize that clinicians will report high satisfaction&#xD;
      rates with the Dashboard and endorse its continued use in clinical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2014</start_date>
  <completion_date type="Actual">November 1, 2015</completion_date>
  <primary_completion_date type="Actual">November 1, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of using the Ginger.io app</measure>
    <time_frame>end of study, maximum of 18 months</time_frame>
    <description>measured by number of enrolled and active participants versus total patient population invited</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the Ginger.io app</measure>
    <time_frame>6 months</time_frame>
    <description>Measured with satisfaction survey ratings of Ginger.io by patients and clinicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Psychiatric Rating Scale (BPRS)</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Brief Psychiatric Rating Scale (BPRS) is a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Functioning Scale:Social</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Global Functioning Scale: Social provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Critical Incidents</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Count of clinic contacts, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CGI</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>The CGI (Haro et al., 2003) is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Assessment of Functioning</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>The GAF is a numeric scale (0 through 100) that provides a rating of an individual's social, occupation, and psychological functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Functioning Scale: Role</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Global Functioning Scale: Role provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence (MARS)</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>The MARS is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic Alliance</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Therapeutic alliance will be assessed with the STAR (Mcguire-Snieckus et al., 2007), a 12-item questionnaire with patient and clinician versions assessing positive collaboration and positive clinician input (both versions), non-supportive input (patient version), and emotional difficulties (clinician version).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insight</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Patient's insight into their illness will be assessed using the IS (Birchwood et al., 1994), an 8-item self-report questionnaire assessing awareness of illness, need for treatment, and attribution of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant patient alerts</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>Clinician responses to patient alerts within the Ginger.io Dashboard, indicating response to alert and whether it was clinically relevant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of Care</measure>
    <time_frame>through study completion, maximum of 18 months</time_frame>
    <description>The historical average monthly and annual cost of care per patient will be compared to the average monthly and annual cost of care during and following completion of the project.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Psychosis</condition>
  <condition>Clinical High Risk for Psychosis</condition>
  <arm_group>
    <arm_group_label>Clinical high risk (CHR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects at clinical high risk (CHR) for psychosis and/or bipolar disorder, aged 13-30 years. CHR participants will have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year. Assigned Mobile health application - Ginger.io</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First Episode Psychosis (FEP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First Episode Psychosis (FEP) subjects aged 13-30 meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder. FEP participants will be ascertained three years or less from illness onset and have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e. schizophrenia) according to DSM-IV criteria. Assigned Mobile health application - Ginger.io</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls (HC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy individuals with no current/past axis I disorders according to DSM-IV criteria and no first-degree relative with a psychotic disorder. Assigned Mobile health application - Ginger.io</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile health application - Ginger.io</intervention_name>
    <description>the Ginger.io is a smartphone application allowing for daily surveys assessing mood and social interactions, and weekly surveys assessing symptoms and psychosocial functioning. Collects passive movement and interaction data</description>
    <arm_group_label>Clinical high risk (CHR)</arm_group_label>
    <arm_group_label>First Episode Psychosis (FEP)</arm_group_label>
    <arm_group_label>Healthy Controls (HC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 13-30, English fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ Below 70, history of neurological disorders, or current substance abuse/dependence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tara A Niendam, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis Dept of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Imaging Research Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early psychosis</keyword>
  <keyword>clinical high risk</keyword>
  <keyword>mobile health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental 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/NCT03303456
org study id: 563584
nct id: NCT03303456
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project tests the feasibility of implementing a smartphone application - Ginger.io - in
      the UC Davis Early Psychosis Program, and investigates whether mobile health technology can
      improve treatment delivery and outcomes in individuals with early psychosis. Ginger.io is a
      smartphone application that utilizes methods of passive data collection (i.e. data gathered
      without active interaction/contribution from the user) to gather communication, movement, and
      interaction data from smartphone devices to model individuals' social, physical, and mental
      health. These models are used to infer health-related outcomes and could inform treatment. By
      implementing the Ginger.io application in the UC Davis Early Psychosis Program with an
      integrated clinical and research infrastructure, the investigators will be able to quickly
      determine its feasibility for use in early psychosis populations, while simultaneously
      developing its ability to systematically capture aspects of relapse and recovery that are
      unique to this patient population.

      Objectives: This project has three principle objectives related to early psychosis care: 1)
      improve treatment delivery, 2) improve patient outcomes, and 3) lower treatment costs. The
      project will target individuals in the early stages of psychotic illness, including
      individuals at high risk for developing a psychotic illness (termed "clinical high risk" or
      CHR) and individuals within three years of their first psychotic episode (termed "first
      episode psychosis" or FEP). The early stages of psychotic illness represent a critical period
      for intervention; early identification of clinical deterioration and subsequent targeted
      intervention is crucial for rapid remission of symptoms and reduced relapse rates. However,
      without the information necessary to identify patients in need of such intervention,
      providers are limited in their ability to respond rapidly. Within the UCD Early Psychosis
      Program, a mobile health application such as Ginger.io has the potential to equip the
      providers and caregivers with valuable insight into a patient's status in real-time without
      the burden of increased appointments and intrusive monitoring, allowing the identification of
      early psychosis patients most in need of outreach, and routing of treatment resources to the
      right patients at the right time.
The project comprises two phases. In both phases, patients will use the Ginger.io app on
      their mobile device to complete daily surveys assessing mood and social interactions, and
      weekly surveys assessing symptoms. Patients will also complete monthly gold-standard clinical
      interviews at the UC Davis Early Psychosis Program. Once enrolled, the investigators will ask
      patients to participate for the duration of the study, a total of 14 months across Phase I
      and II.

      Phase I involves the collection of pilot data to assess feasibility and conduct exploratory
      analyses. Participants will include individuals in the earliest stages of psychosis (CHR and
      FEP). The investigators will recruit 60 participants to allow for 15% dropout, aiming to
      obtain complete data on 50 participants. Given the emphasis on feasibility and acceptability
      in Phase I, research staff will monitor patient Dashboards daily and provide clinicians with
      weekly summaries for each patient. Clinicians and patients will provide ratings on
      satisfaction and effect of Ginger.io on treatment at the end of Phase I.

      Specific aims for Phase I are as follows:

      Specific Aim 1: Determine the feasibility and acceptability of Ginger.io in an early
      psychosis population.

      Feasibility will be measured by utilization of the application (i.e. number of enrolled and
      active participants versus total patient population invited). Acceptability will be measured
      with satisfaction survey ratings of Ginger.io by patients and clinicians. Analysis will
      include summary statistics reporting utilization rates and satisfaction ratings. The
      investigators hypothesize high utilization of Ginger.io and low dropout, as well as high
      satisfaction and endorsement of continued use of Ginger.io.

      Specific Aim 2: Identify passive behavior data associated with gold-standard measures of
      clinical symptoms and social functioning.

      The investigators will examine associations between passive and active data collected via
      Ginger.io. The investigators will then validate both the active and passive behavior data by
      examining associations with symptom and social functioning ratings obtained via gold-standard
      clinical interviews conducted at monthly research evaluations. The investigators hypothesize
      patients' passive interaction data will positively associate with active survey data of
      symptoms and social interactions (e.g. increase reports of mood will relate to more
      texts/calls), and that both active and passive data regarding symptoms and social behavior
      will relate to gold-standard clinical measures of symptoms and social functioning.

      Specific Aim 3: Identify Ginger.io data related to key patient outcomes to inform calibration
      of patient status alerts.

      Exploratory analyses using regression models and repeated measure GLMs will examine whether
      the passive and active data from Ginger.io statistically predict key patient outcomes,
      including psychotic symptom flares, increased clinic contact, psychiatric ER visits or
      hospitalizations, and progression from a high risk state to first episode psychosis. The
      investigators hypothesize reductions in phone calls/text messages and/or increases in
      self-reported ratings of basic symptoms will predict psychotic symptom flares, increased
      clinic utilization, psychiatric ER visits and hospitalizations. This analysis will be used to
      calibrate patient status alerts for Phase II that will notify clinicians which patients are
      at risk of symptom exacerbation and relapse.

      Specific Aim 4: Evaluate effect of Ginger.io on key treatment variables. Key variables of
      interest are medication adherence, therapeutic alliance, and insight. All three variables
      will be measured using self-report questionnaires (see Procedures Involved) administered to
      patients at the beginning and end of the project, and as part of the monthly clinical
      interviews, enabling the evaluation of change over time. The investigators hypothesize that,
      following three months of Ginger.io use, patients will report improved medication adherence,
      therapeutic alliance, and insight into their illness.

      Phase II will extend the findings of Phase I through the implementation of Ginger.io in the
      UC Davis Early Psychosis Programs (EDAPT and SacEDAPT) to allow clinicians to directly
      interact with the Dashboard and integrate its information directly into patient care.
      Patients will continue to complete daily and weekly surveys via Ginger.io, and monthly
      clinical assessments with research staff. Additionally, clinicians will monitor patient
      Dashboards on a daily basis and will respond to patient status alerts as they arise (see Aim
      2 below). Phase I participants will be asked to remain in the study through Phase II,
      yielding a more comprehensive longitudinal dataset. Phase II will involve a total of 120
      participants (combined Phase I and newly recruited participants) to account for 15% dropout,
      aiming to obtain data for at least 100 participants.

      Phase II has four specific aims.

      Specific Aim 1: Continue to validate predictive value of Ginger.io data related to key
      patient outcomes.

      This is a direct extension of Aim 3 in Phase I and will be addressed through continued linear
      modeling of passive and active data from Ginger.io to identify and test statistical
      predictors of key patient outcomes. This will facilitate continued calibration of patient
      status alerts used in the Dashboard to notify clinicians when patients are at risk of
      clinical deterioration.

      Specific Aim 2: Evaluate effect of patient status alerts on treatment delivery. Key variables
      of interest include clinician-rated utility of the patient status alerts, clinician choice of
      treatment delivery following an alert, and the action response time following notification of
      an alert. In response to each alert, clinicians will indicate the type of clinical
      intervention they pursued (e.g. "called patient to check in", "scheduled appointment with
      psychiatrist"). All treatment will be clinician-driven and provided in a naturalistic manner,
      and data will be collected on the types of treatments chosen for a given alert. Clinicians
      will also rate the utility (e.g. not useful/useful) of the alert based on information
      gathered during follow-up. Action response time will be recorded via Dashboard interaction.
      Preliminary analyses will be exploratory and will inform continued improvements to the
      Dashboard and calibration of patient status alerts. Summary statistics regarding clinician
      responses, average response time, and utility ratings will be included. The investigators
      hypothesize that clinicians will rate patient status alerts as useful and informative to
      their treatment planning and intervention.

      Specific Aim 3: Analysis of the impact of Ginger.io on cost of care. Key variables of
      interest include cost of outpatient care, and psychiatric ER visits and hospitalizations. To
      evaluate the impact of Ginger.io, the historical average monthly and annual cost of care per
      patient will be compared to the average monthly and annual cost of care during and following
      completion of the project. The investigators hypothesize that implementation of Ginger.io
      will reduce the number and duration of psychiatric ER visits and hospitalizations, thereby
      reducing costs.

      Specific Aim 4: Continued evaluation of feasibility and acceptability of Ginger.io in an
      early psychosis population.

      The investigators will continue to evaluate feasibility and acceptability of Ginger.io in
      both patients and clinicians using satisfaction surveys. The investigators hypothesize that
      patients will continue to endorse high satisfaction rates and continued use of Ginger.io.
      Additionally, the investigators hypothesize that clinicians will report high satisfaction
      rates with the Dashboard and endorse its continued use in clinical care.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility of using the Ginger.io app
time frame: end of study, maximum of 18 months
description: measured by number of enrolled and active participants versus total patient population invited
measure: Acceptability of the Ginger.io app
time frame: 6 months
description: Measured with satisfaction survey ratings of Ginger.io by patients and clinicians.
measure: Brief Psychiatric Rating Scale (BPRS)
time frame: through study completion, maximum of 18 months
description: Brief Psychiatric Rating Scale (BPRS) is a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.
measure: Global Functioning Scale:Social
time frame: through study completion, maximum of 18 months
description: Global Functioning Scale: Social provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.
measure: Critical Incidents
time frame: through study completion, maximum of 18 months
description: Count of clinic contacts, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.
measure: CGI
time frame: through study completion, maximum of 18 months
description: The CGI (Haro et al., 2003) is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings.
measure: Global Assessment of Functioning
time frame: through study completion, maximum of 18 months
description: The GAF is a numeric scale (0 through 100) that provides a rating of an individual's social, occupation, and psychological functioning.
measure: Global Functioning Scale: Role
time frame: through study completion, maximum of 18 months
description: Global Functioning Scale: Role provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.
measure: Medication Adherence (MARS)
time frame: through study completion, maximum of 18 months
description: The MARS is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects.
measure: Therapeutic Alliance
time frame: through study completion, maximum of 18 months
description: Therapeutic alliance will be assessed with the STAR (Mcguire-Snieckus et al., 2007), a 12-item questionnaire with patient and clinician versions assessing positive collaboration and positive clinician input (both versions), non-supportive input (patient version), and emotional difficulties (clinician version).
measure: Insight
time frame: through study completion, maximum of 18 months
description: Patient's insight into their illness will be assessed using the IS (Birchwood et al., 1994), an 8-item self-report questionnaire assessing awareness of illness, need for treatment, and attribution of symptoms.
measure: Clinically relevant patient alerts
time frame: through study completion, maximum of 18 months
description: Clinician responses to patient alerts within the Ginger.io Dashboard, indicating response to alert and whether it was clinically relevant
measure: Cost of Care
time frame: through study completion, maximum of 18 months
description: The historical average monthly and annual cost of care per patient will be compared to the average monthly and annual cost of care during and following completion of the project.
arm group label: Clinical high risk (CHR)
arm group type: Experimental
description: Subjects at clinical high risk (CHR) for psychosis and/or bipolar disorder, aged 13-30 years. CHR participants will have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year. Assigned Mobile health application - Ginger.io
arm group label: First Episode Psychosis (FEP)
arm group type: Experimental
description: First Episode Psychosis (FEP) subjects aged 13-30 meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder. FEP participants will be ascertained three years or less from illness onset and have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e. schizophrenia) according to DSM-IV criteria. Assigned Mobile health application - Ginger.io
arm group label: Healthy Controls (HC)
arm group type: Experimental
description: Healthy individuals with no current/past axis I disorders according to DSM-IV criteria and no first-degree relative with a psychotic disorder. Assigned Mobile health application - Ginger.io
intervention type: Other
intervention name: Mobile health application - Ginger.io
description: the Ginger.io is a smartphone application allowing for daily surveys assessing mood and social interactions, and weekly surveys assessing symptoms and psychosocial functioning. Collects passive movement and interaction data
arm group label: Clinical high risk (CHR)
arm group label: First Episode Psychosis (FEP)
arm group label: Healthy Controls (HC)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tara A Niendam, Ph.D.
role: Principal Investigator
affiliation: UC Davis Dept of Psychiatry
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: Undecided