<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/NCT03766503</url>
  </required_header>
  <id_info>
    <org_study_id>H2016:321</org_study_id>
    <nct_id>NCT03766503</nct_id>
  </id_info>
  <brief_title>Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe/Persistent Mental Illness</brief_title>
  <official_title>Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe and Persistent Mental Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Winnipeg Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</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>
      The main study intervention is the daily witnessing of participant self-administration of&#xD;
      medications by trained pharmacy staff to ensure compliance. The staff in question will be&#xD;
      provided by Leila pharmacy and will in addition provide support so that individuals can&#xD;
      transition back into living independently through reminders to attend regularly scheduled&#xD;
      medical appointments and counseling on correct use of prescribed medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The program is designed to serve individuals with severe and persistent mental illnesses who&#xD;
      have been repeatedly hospitalized, are repeat users of community crisis services, or are&#xD;
      frequently in contact with the criminal justice system. There are several objectives of this&#xD;
      new approach. First, the investigators believe that these patients are invested in working&#xD;
      with the daily dispensing program to stay well, but individual factors related to their&#xD;
      personal background or symptoms of their illness contribute to frequent non-adherence to&#xD;
      medications. Non-adherence to medications then leads to behaviour that results in frequent&#xD;
      use of very expensive services such as the criminal justice system, acute care hospital beds,&#xD;
      and crisis services. Working collaboratively with the patient to improve adherence to&#xD;
      medications in partnership with a private pharmacy that absorbs costs of the program is a&#xD;
      less coercive model than injectable medications, which is the current standard for working&#xD;
      with this population. In addition, oral medications are much less expensive than the newer&#xD;
      injectable antipsychotics and the costs of running a &quot;depot clinic&quot; where the injectable&#xD;
      medications are provided. At this time, there has been no effective program to ensure&#xD;
      compliance with oral medications in the published literature.&#xD;
&#xD;
      The primary purpose of this study is to evaluate the effectiveness of this new model for&#xD;
      decreasing the harmful effects of relapses to psychosis resulting from non-adherence to&#xD;
      medications. Specifically, the investigators plan to examine whether or not this program&#xD;
      results in less use of crisis services, acute care hospitalization and less contact with the&#xD;
      criminal justice system. The investigators plan to evaluate client response through a&#xD;
      self-reported measure and to assess client satisfaction by conducting participant&#xD;
      satisfaction survey for the program. Key stakeholders will be engaged during the process&#xD;
      (e.g., community mental health workers, probation officers, pharmacists) to gather&#xD;
      information and suggestions regarding the daily dispensing program. Based on feedback from&#xD;
      clients and stakeholders, the investigators will then aim to implement improvements to the&#xD;
      process to optimize its effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2016</start_date>
  <completion_date type="Actual">February 11, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Self-Report Measure (Client Coercion Survey)</measure>
    <time_frame>This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.</time_frame>
    <description>The questionnaire asks about the client's perceptions of care which will help measure the effectiveness of the study's recovery intervention (Daily Dispensing program) by evaluating patient response to the program through this self-reported measure. The measure is composed of three subscales: Perceived Coercion (items scored as False=1; True/Don't Know=0); Negative Pressures (items scored as False=1; True/Don't Know=0; except item 12 is reverse scored); Voice (items scored as False=1; True/Don't Know=0; except item 13 which is reverse scored). The Perceived Coercion subscale ranges from 0 (minimum score) to 5 (maximum score) and lower values reflect better outcomes; the Negative Pressures subscale ranges from 0 (minimum score) to 6 (maximum score) and higher values reflect better outcomes; the Voice subscale ranges from 0 (minimum score) to 3 (maximum score) and lower values reflect better outcomes. The subscales will not be combined to compute a total score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stakeholder survey</measure>
    <time_frame>This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.</time_frame>
    <description>The researchers will engage key stakeholders during the project (e.g., community mental health workers, psychiatrists, pharmacists) to gather information and suggestions regarding the Daily Dispensing program. Based on feedback stakeholders, the researchers will then aim to implement improvements to the program to optimize its effectiveness. The survey uses a 5 point Likert scale and items are scored from 1 to 5 (and the negative questions items 8, 10, 12 are reverse scored) with lower scores indicating better outcomes. The scale contains 11 items that can be summed (items: 3-12, 15) - the maximum score for this scale is 55 (5 x 11 items) and the minimum score is 11 (1 x 11 items). The Stakeholder Survey has no subscales. The survey also features 7 descriptive items (items: 1, 2, 13, 14, 16-19) and these will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Measure</measure>
    <time_frame>This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.</time_frame>
    <description>The survey measures clients' satisfaction regarding program and consists of several domains but no real subscales: accessibility, availability of resources, continuity of care, outcome of care, humanness of program staff, information gathering, information giving, pleasantness of surroundings, competence of staff, and quality of program. The survey was further modified by the Daily Dispensing team. The survey uses a 5 point Likert scale and items are scored from 1 to 5 with lower scores indicating better outcomes. There are no reverse scored items. The scale contains 26 items that can be summed - the maximum score for the Client Satisfaction Scale is 130 (5 x 26 items) and the minimum score is 26 (1 x 26 items). Items 27-29 are descriptive and these will be reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Daily</intervention_name>
    <description>The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals currently enrolled in the new daily dispensing program&#xD;
&#xD;
          -  Individuals with severe and persistent mental illnesses&#xD;
&#xD;
          -  Individuals who have been repeatedly hospitalized, are repeat users of community&#xD;
             crisis services, or are in frequently in contact with the criminal justice system&#xD;
&#xD;
          -  Individuals who are involved in the Forensics program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are not currently in the Forensics program&#xD;
&#xD;
          -  Individuals who are part of the daily dispensing program, but are not Forensic&#xD;
             outpatients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Waldman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Emsley R, Oosthuizen P, Koen L, Niehaus D, Martinez L. Comparison of treatment response in second-episode versus first-episode schizophrenia. J Clin Psychopharmacol. 2013 Feb;33(1):80-3. doi: 10.1097/JCP.0b013e31827bfcc1.</citation>
    <PMID>23277247</PMID>
  </reference>
  <reference>
    <citation>Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.</citation>
    <PMID>16368053</PMID>
  </reference>
  <reference>
    <citation>Keers R, Ullrich S, Destavola BL, Coid JW. Association of violence with emergence of persecutory delusions in untreated schizophrenia. Am J Psychiatry. 2014 Mar;171(3):332-9. doi: 10.1176/appi.ajp.2013.13010134.</citation>
    <PMID>24220644</PMID>
  </reference>
  <reference>
    <citation>Patel MX, de Zoysa N, Bernadt M, Bindman J, David AS. Are depot antipsychotics more coercive than tablets? The patient's perspective. J Psychopharmacol. 2010 Oct;24(10):1483-9. doi: 10.1177/0269881109103133. Epub 2009 Mar 20.</citation>
    <PMID>19304865</PMID>
  </reference>
  <reference>
    <citation>Patel MX, de Zoysa N, Bernadt M, David AS. A cross-sectional study of patients' perspectives on adherence to antipsychotic medication: depot versus oral. J Clin Psychiatry. 2008 Oct;69(10):1548-56. doi: 10.4088/jcp.v69n1004. Epub 2008 Sep 23.</citation>
    <PMID>19192437</PMID>
  </reference>
  <reference>
    <citation>Rossler W, Salize HJ, van Os J, Riecher-Rossler A. Size of burden of schizophrenia and psychotic disorders. Eur Neuropsychopharmacol. 2005 Aug;15(4):399-409. doi: 10.1016/j.euroneuro.2005.04.009.</citation>
    <PMID>15925493</PMID>
  </reference>
  <reference>
    <citation>Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:19-23.</citation>
    <PMID>16822093</PMID>
  </reference>
  <reference>
    <citation>Thornicroft G, Brohan E, Rose D, Sartorius N, Leese M; INDIGO Study Group. Global pattern of experienced and anticipated discrimination against people with schizophrenia: a cross-sectional survey. Lancet. 2009 Jan 31;373(9661):408-15. doi: 10.1016/S0140-6736(08)61817-6. Epub 2009 Jan 21.</citation>
    <PMID>19162314</PMID>
  </reference>
  <results_reference>
    <citation>Angermeyer MC, Matschinger H. The stereotype of schizophrenia and its impact on discrimination against people with schizophrenia: results from a representative survey in Germany. Schizophr Bull. 2004;30(4):1049-61. doi: 10.1093/oxfordjournals.schbul.a007120.</citation>
    <PMID>15954207</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medication adherence</keyword>
  <keyword>Severe and persistent mental illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All patient personal health information: Personal Health Information Number (PHIN), name and date of birth will be stored in a secured database (REDCAP) for the duration of the project. Analysis will be done on aggregate data only stripped from personal health identifiers. Database will be archived in REDCAP with access only by authorized individuals.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>The data will be collected over a span of 12 months and be retained for seven years.</ipd_time_frame>
    <ipd_access_criteria>Only authorized project staff will have access to patient medical information. Aggregate data will be made available for sharing with other organizations.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03766503/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03766503/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 22, 2021</submitted>
    <returned>September 16, 2021</returned>
  </pending_results>
  <!-- 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/NCT03766503
org study id: H2016:321
nct id: NCT03766503
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main study intervention is the daily witnessing of participant self-administration of
      medications by trained pharmacy staff to ensure compliance. The staff in question will be
      provided by Leila pharmacy and will in addition provide support so that individuals can
      transition back into living independently through reminders to attend regularly scheduled
      medical appointments and counseling on correct use of prescribed medications.
The program is designed to serve individuals with severe and persistent mental illnesses who
      have been repeatedly hospitalized, are repeat users of community crisis services, or are
      frequently in contact with the criminal justice system. There are several objectives of this
      new approach. First, the investigators believe that these patients are invested in working
      with the daily dispensing program to stay well, but individual factors related to their
      personal background or symptoms of their illness contribute to frequent non-adherence to
      medications. Non-adherence to medications then leads to behaviour that results in frequent
      use of very expensive services such as the criminal justice system, acute care hospital beds,
      and crisis services. Working collaboratively with the patient to improve adherence to
      medications in partnership with a private pharmacy that absorbs costs of the program is a
      less coercive model than injectable medications, which is the current standard for working
      with this population. In addition, oral medications are much less expensive than the newer
      injectable antipsychotics and the costs of running a "depot clinic" where the injectable
      medications are provided. At this time, there has been no effective program to ensure
      compliance with oral medications in the published literature.

      The primary purpose of this study is to evaluate the effectiveness of this new model for
      decreasing the harmful effects of relapses to psychosis resulting from non-adherence to
      medications. Specifically, the investigators plan to examine whether or not this program
      results in less use of crisis services, acute care hospitalization and less contact with the
      criminal justice system. The investigators plan to evaluate client response through a
      self-reported measure and to assess client satisfaction by conducting participant
      satisfaction survey for the program. Key stakeholders will be engaged during the process
      (e.g., community mental health workers, probation officers, pharmacists) to gather
      information and suggestions regarding the daily dispensing program. Based on feedback from
      clients and stakeholders, the investigators will then aim to implement improvements to the
      process to optimize its effectiveness.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient Self-Report Measure (Client Coercion Survey)
time frame: This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.
description: The questionnaire asks about the client's perceptions of care which will help measure the effectiveness of the study's recovery intervention (Daily Dispensing program) by evaluating patient response to the program through this self-reported measure. The measure is composed of three subscales: Perceived Coercion (items scored as False=1; True/Don't Know=0); Negative Pressures (items scored as False=1; True/Don't Know=0; except item 12 is reverse scored); Voice (items scored as False=1; True/Don't Know=0; except item 13 which is reverse scored). The Perceived Coercion subscale ranges from 0 (minimum score) to 5 (maximum score) and lower values reflect better outcomes; the Negative Pressures subscale ranges from 0 (minimum score) to 6 (maximum score) and higher values reflect better outcomes; the Voice subscale ranges from 0 (minimum score) to 3 (maximum score) and lower values reflect better outcomes. The subscales will not be combined to compute a total score.
measure: Stakeholder survey
time frame: This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.
description: The researchers will engage key stakeholders during the project (e.g., community mental health workers, psychiatrists, pharmacists) to gather information and suggestions regarding the Daily Dispensing program. Based on feedback stakeholders, the researchers will then aim to implement improvements to the program to optimize its effectiveness. The survey uses a 5 point Likert scale and items are scored from 1 to 5 (and the negative questions items 8, 10, 12 are reverse scored) with lower scores indicating better outcomes. The scale contains 11 items that can be summed (items: 3-12, 15) - the maximum score for this scale is 55 (5 x 11 items) and the minimum score is 11 (1 x 11 items). The Stakeholder Survey has no subscales. The survey also features 7 descriptive items (items: 1, 2, 13, 14, 16-19) and these will be reported.
measure: Client Satisfaction Measure
time frame: This study will employ a crossover design where data is collected for 12 months during the study and compared to baseline data retrieved for 12 months for each patient before enrollment into the project.
description: The survey measures clients' satisfaction regarding program and consists of several domains but no real subscales: accessibility, availability of resources, continuity of care, outcome of care, humanness of program staff, information gathering, information giving, pleasantness of surroundings, competence of staff, and quality of program. The survey was further modified by the Daily Dispensing team. The survey uses a 5 point Likert scale and items are scored from 1 to 5 with lower scores indicating better outcomes. There are no reverse scored items. The scale contains 26 items that can be summed - the maximum score for the Client Satisfaction Scale is 130 (5 x 26 items) and the minimum score is 26 (1 x 26 items). Items 27-29 are descriptive and these will be reported.
arm group label: Intervention
arm group type: Other
description: The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
intervention type: Other
intervention name: Daily
description: The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Waldman, MD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
citation: Emsley R, Oosthuizen P, Koen L, Niehaus D, Martinez L. Comparison of treatment response in second-episode versus first-episode schizophrenia. J Clin Psychopharmacol. 2013 Feb;33(1):80-3. doi: 10.1097/JCP.0b013e31827bfcc1.
PMID: 23277247
citation: Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.
PMID: 16368053
citation: Keers R, Ullrich S, Destavola BL, Coid JW. Association of violence with emergence of persecutory delusions in untreated schizophrenia. Am J Psychiatry. 2014 Mar;171(3):332-9. doi: 10.1176/appi.ajp.2013.13010134.
PMID: 24220644
citation: Patel MX, de Zoysa N, Bernadt M, Bindman J, David AS. Are depot antipsychotics more coercive than tablets? The patient's perspective. J Psychopharmacol. 2010 Oct;24(10):1483-9. doi: 10.1177/0269881109103133. Epub 2009 Mar 20.
PMID: 19304865
citation: Patel MX, de Zoysa N, Bernadt M, David AS. A cross-sectional study of patients' perspectives on adherence to antipsychotic medication: depot versus oral. J Clin Psychiatry. 2008 Oct;69(10):1548-56. doi: 10.4088/jcp.v69n1004. Epub 2008 Sep 23.
PMID: 19192437
citation: Rossler W, Salize HJ, van Os J, Riecher-Rossler A. Size of burden of schizophrenia and psychotic disorders. Eur Neuropsychopharmacol. 2005 Aug;15(4):399-409. doi: 10.1016/j.euroneuro.2005.04.009.
PMID: 15925493
citation: Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:19-23.
PMID: 16822093
citation: Thornicroft G, Brohan E, Rose D, Sartorius N, Leese M; INDIGO Study Group. Global pattern of experienced and anticipated discrimination against people with schizophrenia: a cross-sectional survey. Lancet. 2009 Jan 31;373(9661):408-15. doi: 10.1016/S0140-6736(08)61817-6. Epub 2009 Jan 21.
PMID: 19162314
citation: Angermeyer MC, Matschinger H. The stereotype of schizophrenia and its impact on discrimination against people with schizophrenia: results from a representative survey in Germany. Schizophr Bull. 2004;30(4):1049-61. doi: 10.1093/oxfordjournals.schbul.a007120.
PMID: 15954207
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: All patient personal health information: Personal Health Information Number (PHIN), name and date of birth will be stored in a secured database (REDCAP) for the duration of the project. Analysis will be done on aggregate data only stripped from personal health identifiers. Database will be archived in REDCAP with access only by authorized individuals.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: The data will be collected over a span of 12 months and be retained for seven years.
ipd access criteria: Only authorized project staff will have access to patient medical information. Aggregate data will be made available for sharing with other organizations.
provided document: 
provided document: 
submitted: August 22, 2021
returned: September 16, 2021