<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/NCT03807388</url>
  </required_header>
  <id_info>
    <org_study_id>2018/059</org_study_id>
    <nct_id>NCT03807388</nct_id>
  </id_info>
  <brief_title>ReMindCare App for Patients From First Episode of Psychosis Unit.</brief_title>
  <official_title>The Use of ReMindCare Application for Smartphone in Treatment of Patients From First Episode of Psychosis Unit in the Clinic Hospital of Valencia, Spain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>INCLIVA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Investigacion Sanitaria INCLIVA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitat Politècnica de València</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clínico Universitario de Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>INCLIVA</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      ReMindCare is an app designed by the Unit of Psychiatry at the Clinical Hospital of Valencia&#xD;
      in liaison with the Polytechnic University of Valencia.&#xD;
&#xD;
      This e-Health app gathers information about the clinical health status of patients with&#xD;
      Psychotic Disorder Diagnose through daily and weekly brief assessments.&#xD;
&#xD;
      This information is displayed in a restricted access website, where clinicians can visualize&#xD;
      data from patients as well as download pdf reports of main data collected by the app. These&#xD;
      reports can be attached to the electronic clinical report of the patient at the hospital&#xD;
      database, being accessible for consultation for every clinician involved in treatment of the&#xD;
      patient.&#xD;
&#xD;
      Furthermore, ReMindCare produces different alarms which notify clinicians about variations&#xD;
      into patients health status or the cessation of using the app. Moreover, patients can also&#xD;
      deliberately generate an urgent consultation alarm.&#xD;
&#xD;
      The introduction of ReMindCare app into clinical practice will follow a clinical trial&#xD;
      structure in which treatment as usual (TAU) of patients from a First Episode of Psychosis&#xD;
      Unit will be compared to ReMindCare app intervention program. After participants eligible for&#xD;
      inclusion complete baseline assessments they will be randomly allocated to one of the two&#xD;
      groups (Intervention or TAU) by a basic single blind randomization in which an independent&#xD;
      researcher will perform the allocation using a computerized random number generator.&#xD;
&#xD;
      Information collected through the app and variations into clinical data will be analyzed&#xD;
      among time. First assessment of these data will be conducted after 6 months of patient´s&#xD;
      enrollment into the study. Subsequent analysis will be conducted yearly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Baseline surveys:&#xD;
&#xD;
      Baseline surveys will be administered. In this first evaluation, sociodemographic information&#xD;
      and clinical information such as diagnosis, pattern of antipsychotic treatment, number of&#xD;
      suicide attempts or associated illnesses will be collected.&#xD;
&#xD;
      Furthermore, some structured questionnaires will be administered, including: Clinical Global&#xD;
      Impression Scale (CGI), Global Assessment of Functioning (GAF), Positive and Negative&#xD;
      Syndrome Scale (PANSS), Premorbid Adjustment Scale (PAS), Simplified Medication Adherence&#xD;
      Questionnaire (SMAQ), Drug Attitude Inventory (DAI-10) and Beck Cognitive Insight Scale&#xD;
      (BCIS).&#xD;
&#xD;
      ReMindCare app measures:&#xD;
&#xD;
      Patients will generate the following data by using the app:&#xD;
&#xD;
        1. Data generated through responses to daily and weekly app questionnaires: Answers to&#xD;
           these questionnaires are presented following a Likert scale (1 to 5) as follows: 1=Not&#xD;
           at all, 2=Slightly, 3=Somewhat, 4=Very, 5=Extremely. Responses will be collected and&#xD;
           analyzed.&#xD;
&#xD;
        2. Quantity of &quot;Urgent clinic consultation&quot; request made for every patient.&#xD;
&#xD;
        3. Quantity of automatic usage alarms.&#xD;
&#xD;
      Treatment measures:&#xD;
&#xD;
      Apart from data collected through the use of the app, further information will be collected&#xD;
      related to modifications into de patient´s treatment or related to his/her health status:&#xD;
&#xD;
        -  Modifications into antipsychotic treatment.&#xD;
&#xD;
        -  Number of relapses&#xD;
&#xD;
        -  Number of visits to hospital urgent care unit.&#xD;
&#xD;
        -  Number of hospital admissions&#xD;
&#xD;
      Follow-up measures and satisfaction questionnaire:&#xD;
&#xD;
      Information collected through the app and variations into clinical data will be analyzed&#xD;
      among time. First assessment of these data will be conducted after 6 months of patient´s&#xD;
      enrollment into the study. Subsequent analysis will be conducted yearly.&#xD;
&#xD;
      Patients will also complete a satisfaction questionnaire after one year using the ReMindCare&#xD;
      app or before discontinuing the use the app (if this happens before the first year of use of&#xD;
      the app has come). This app feedback questionnaire is made for the purpose of this research&#xD;
      and it is based in some previous satisfaction and usability questionnaires such as: User&#xD;
      Version of the mobile application rating scale (uMars), System Usability Scale (SUS),&#xD;
      EnLight: Tool for mobile and web-based eHealth interventions and App Quality Evaluation&#xD;
      (AQEL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2019</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to anti-psychotic treatment</measure>
    <time_frame>Yearly, up to 2 years</time_frame>
    <description>Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to treatment</measure>
    <time_frame>Yearly, up to 2 years</time_frame>
    <description>Number of hospital admissions and urgent care visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early relapse detection</measure>
    <time_frame>Yearly, up to 2 years</time_frame>
    <description>Changes in detection of relapses into psychotic sympthoms. Measured by number of contacts to patients in response to alerts generated by the app.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alliance between patient and clinician</measure>
    <time_frame>Yearly, up to 2 years</time_frame>
    <description>Changes in feelings of alliance between patient and clinician. Measured by a Satisfaction Questionnaire, made for the purpose of this research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feeling of empowerment related to illness self-management</measure>
    <time_frame>Yearly, up to 2 years</time_frame>
    <description>Changes in patient´s feelings of empowerment related to illness self-management. Measured by a Satisfaction Questionnaire, made for the purpose of this research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in comunication between clinicians</measure>
    <time_frame>Yearly, up to 2 years</time_frame>
    <description>Study of changes related to comunication between clinicians about treatment of patients. Measured qualitatively by a focus group session.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Psychosis</condition>
  <condition>Schizophrenia</condition>
  <condition>Psychotic Disorders</condition>
  <condition>Delirium</condition>
  <condition>Hallucinations</condition>
  <condition>Adherence, Medication</condition>
  <condition>Treatment Side Effects</condition>
  <arm_group>
    <arm_group_label>ReMindCare Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients from First Episode of Psychosis Unit who will use ReMindCare app.&#xD;
ReMindCare is an user-friendly app which conducts daily evaluations of the health status of patients with psychosis by some quick questions that patients will have to answer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients from First Episode of Psychosis Unit who will follow psychiatric usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReMindCare Intervention Group</intervention_name>
    <description>Daily and weekly assessments of patient´s health status, and generation of alarms related to these answers. Moreover, patients can contact clinicians by an urgent consultation tab.</description>
    <arm_group_label>ReMindCare Intervention Group</arm_group_label>
    <other_name>ReMindCare app</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients from the FEPU at Clinic Hospital of Valencia.&#xD;
&#xD;
          -  Diagnosis of Psychotic Disorder following DSMI-5 [32] criteria.&#xD;
&#xD;
          -  Age between 17 to 65 years old.&#xD;
&#xD;
          -  Owning a smartphone which allows the correct installation and functioning of the App.&#xD;
&#xD;
          -  Owning a smartphone which allows internet connection (not necessary permanent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Mental Disability&#xD;
&#xD;
          -  Lack of abilities in using and mastering mobile devices and internet.&#xD;
&#xD;
          -  Not to sign informed consent sheet.&#xD;
&#xD;
          -  Level of Spanish not fluid.&#xD;
&#xD;
          -  Do not have an own smartphone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julio Sanjuán</last_name>
    <role>Study Director</role>
    <affiliation>INCLIVA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lucia Bonet, PhD</last_name>
    <phone>+34 600745550</phone>
    <email>lbonetm@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>INCLIVA</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Marta Peiró</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Bonet L, Izquierdo C, Escarti MJ, Sancho JV, Arce D, Blanquer I, Sanjuan J. Use of mobile technologies in patients with psychosis: A systematic review. Rev Psiquiatr Salud Ment. 2017 Jul-Sep;10(3):168-178. doi: 10.1016/j.rpsm.2017.01.003. Epub 2017 Mar 1. English, Spanish.</citation>
    <PMID>28258835</PMID>
  </reference>
  <reference>
    <citation>Bonet L, Llacer B, Hernandez-Viadel M, Arce D, Blanquer I, Canete C, Escarti M, Gonzalez-Pinto AM, Sanjuan J. Differences in the Use and Opinions About New eHealth Technologies Among Patients With Psychosis: Structured Questionnaire. JMIR Ment Health. 2018 Jul 25;5(3):e51. doi: 10.2196/mental.9950.</citation>
    <PMID>30045835</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Lucia Bonet</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>eHealth</keyword>
  <keyword>mHealth</keyword>
  <keyword>smartphone</keyword>
  <keyword>app</keyword>
  <keyword>psychosis</keyword>
  <keyword>adherence</keyword>
  <keyword>early intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallucinations</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We plan to share the following IPD data. However they will be analyzed as a group:&#xD;
Responses to the following questionnaires:&#xD;
Clinical Global Impression Scale (CGI)&#xD;
Global Assessment of Functioning (GAF)&#xD;
Positive and Negative Syndrome Scale (PANSS)&#xD;
Simplified Medication Adherence Questionnaire (SMAQ)&#xD;
Drug Attitude Inventory (DAI-10)&#xD;
Beck Cognitive Insight Scale (BCIS)&#xD;
Socio-demographics information such as: Age, gender, ethnicity education, marital status, living situation.&#xD;
Answers of patient to ReMindCare app assessments: Daily / weekly responses and alarms generated&#xD;
Treatment related measures:&#xD;
Modifications into antipsychotic treatment.&#xD;
Number of relapses&#xD;
Number of visits to hospital urgent care unit.&#xD;
Number of hospital admissions</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data has been sent for publication in an open access journal.</ipd_time_frame>
  </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/NCT03807388
org study id: 2018/059
nct id: NCT03807388
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
ReMindCare is an app designed by the Unit of Psychiatry at the Clinical Hospital of Valencia
      in liaison with the Polytechnic University of Valencia.

      This e-Health app gathers information about the clinical health status of patients with
      Psychotic Disorder Diagnose through daily and weekly brief assessments.

      This information is displayed in a restricted access website, where clinicians can visualize
      data from patients as well as download pdf reports of main data collected by the app. These
      reports can be attached to the electronic clinical report of the patient at the hospital
      database, being accessible for consultation for every clinician involved in treatment of the
      patient.

      Furthermore, ReMindCare produces different alarms which notify clinicians about variations
      into patients health status or the cessation of using the app. Moreover, patients can also
      deliberately generate an urgent consultation alarm.

      The introduction of ReMindCare app into clinical practice will follow a clinical trial
      structure in which treatment as usual (TAU) of patients from a First Episode of Psychosis
      Unit will be compared to ReMindCare app intervention program. After participants eligible for
      inclusion complete baseline assessments they will be randomly allocated to one of the two
      groups (Intervention or TAU) by a basic single blind randomization in which an independent
      researcher will perform the allocation using a computerized random number generator.

      Information collected through the app and variations into clinical data will be analyzed
      among time. First assessment of these data will be conducted after 6 months of patient´s
      enrollment into the study. Subsequent analysis will be conducted yearly.
Baseline surveys:

      Baseline surveys will be administered. In this first evaluation, sociodemographic information
      and clinical information such as diagnosis, pattern of antipsychotic treatment, number of
      suicide attempts or associated illnesses will be collected.

      Furthermore, some structured questionnaires will be administered, including: Clinical Global
      Impression Scale (CGI), Global Assessment of Functioning (GAF), Positive and Negative
      Syndrome Scale (PANSS), Premorbid Adjustment Scale (PAS), Simplified Medication Adherence
      Questionnaire (SMAQ), Drug Attitude Inventory (DAI-10) and Beck Cognitive Insight Scale
      (BCIS).

      ReMindCare app measures:

      Patients will generate the following data by using the app:

        1. Data generated through responses to daily and weekly app questionnaires: Answers to
           these questionnaires are presented following a Likert scale (1 to 5) as follows: 1=Not
           at all, 2=Slightly, 3=Somewhat, 4=Very, 5=Extremely. Responses will be collected and
           analyzed.

        2. Quantity of "Urgent clinic consultation" request made for every patient.

        3. Quantity of automatic usage alarms.

      Treatment measures:

      Apart from data collected through the use of the app, further information will be collected
      related to modifications into de patient´s treatment or related to his/her health status:

        -  Modifications into antipsychotic treatment.

        -  Number of relapses

        -  Number of visits to hospital urgent care unit.

        -  Number of hospital admissions

      Follow-up measures and satisfaction questionnaire:

      Information collected through the app and variations into clinical data will be analyzed
      among time. First assessment of these data will be conducted after 6 months of patient´s
      enrollment into the study. Subsequent analysis will be conducted yearly.

      Patients will also complete a satisfaction questionnaire after one year using the ReMindCare
      app or before discontinuing the use the app (if this happens before the first year of use of
      the app has come). This app feedback questionnaire is made for the purpose of this research
      and it is based in some previous satisfaction and usability questionnaires such as: User
      Version of the mobile application rating scale (uMars), System Usability Scale (SUS),
      EnLight: Tool for mobile and web-based eHealth interventions and App Quality Evaluation
      (AQEL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Adherence to anti-psychotic treatment
time frame: Yearly, up to 2 years
description: Adherence to anti-psychotic medication intake. Measured by: Simplified Medication Adherence Questionnaire (SMAQ).
measure: Adherence to treatment
time frame: Yearly, up to 2 years
description: Number of hospital admissions and urgent care visits
measure: Early relapse detection
time frame: Yearly, up to 2 years
description: Changes in detection of relapses into psychotic sympthoms. Measured by number of contacts to patients in response to alerts generated by the app.
measure: Alliance between patient and clinician
time frame: Yearly, up to 2 years
description: Changes in feelings of alliance between patient and clinician. Measured by a Satisfaction Questionnaire, made for the purpose of this research.
measure: Feeling of empowerment related to illness self-management
time frame: Yearly, up to 2 years
description: Changes in patient´s feelings of empowerment related to illness self-management. Measured by a Satisfaction Questionnaire, made for the purpose of this research.
measure: Changes in comunication between clinicians
time frame: Yearly, up to 2 years
description: Study of changes related to comunication between clinicians about treatment of patients. Measured qualitatively by a focus group session.
arm group label: ReMindCare Intervention Group
arm group type: Experimental
description: Patients from First Episode of Psychosis Unit who will use ReMindCare app.
ReMindCare is an user-friendly app which conducts daily evaluations of the health status of patients with psychosis by some quick questions that patients will have to answer.
arm group label: Treatment as Usual
arm group type: Other
description: Patients from First Episode of Psychosis Unit who will follow psychiatric usual care.
intervention type: Device
intervention name: ReMindCare Intervention Group
description: Daily and weekly assessments of patient´s health status, and generation of alarms related to these answers. Moreover, patients can contact clinicians by an urgent consultation tab.
arm group label: ReMindCare Intervention Group
other name: ReMindCare app
intervention type: Other
intervention name: Treatment as Usual
description: Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 17 Years
maximum age: 65 Years
healthy volunteers: No
last name: Julio Sanjuán
role: Study Director
affiliation: INCLIVA
last name: Lucia Bonet, PhD
phone: +34 600745550
email: lbonetm@gmail.com
facility: 
contact: 
country: Spain
citation: Bonet L, Izquierdo C, Escarti MJ, Sancho JV, Arce D, Blanquer I, Sanjuan J. Use of mobile technologies in patients with psychosis: A systematic review. Rev Psiquiatr Salud Ment. 2017 Jul-Sep;10(3):168-178. doi: 10.1016/j.rpsm.2017.01.003. Epub 2017 Mar 1. English, Spanish.
PMID: 28258835
citation: Bonet L, Llacer B, Hernandez-Viadel M, Arce D, Blanquer I, Canete C, Escarti M, Gonzalez-Pinto AM, Sanjuan J. Differences in the Use and Opinions About New eHealth Technologies Among Patients With Psychosis: Structured Questionnaire. JMIR Ment Health. 2018 Jul 25;5(3):e51. doi: 10.2196/mental.9950.
PMID: 30045835
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Lucia Bonet
investigator title: Principal Investigator
mesh term: Hallucinations
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: We plan to share the following IPD data. However they will be analyzed as a group:
Responses to the following questionnaires:
Clinical Global Impression Scale (CGI)
Global Assessment of Functioning (GAF)
Positive and Negative Syndrome Scale (PANSS)
Simplified Medication Adherence Questionnaire (SMAQ)
Drug Attitude Inventory (DAI-10)
Beck Cognitive Insight Scale (BCIS)
Socio-demographics information such as: Age, gender, ethnicity education, marital status, living situation.
Answers of patient to ReMindCare app assessments: Daily / weekly responses and alarms generated
Treatment related measures:
Modifications into antipsychotic treatment.
Number of relapses
Number of visits to hospital urgent care unit.
Number of hospital admissions
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data has been sent for publication in an open access journal.