<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/NCT01729572</url>
  </required_header>
  <id_info>
    <org_study_id>0004-12-SHA</org_study_id>
    <nct_id>NCT01729572</nct_id>
  </id_info>
  <brief_title>Measuring the Effect of Remote Monitoring of Treatment Adherence on the Risk of Re-admission of Ambulatory Schizophrenic Patients</brief_title>
  <official_title>The Effect of add-on Tele Medicine Monitoring of Medication Adherence, on the Risk of Re-hospitalisation of Ambulatory Schizophrenic Patients. an Open, Prospective, Randomised Controled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shalvata Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SHL Telemedicine Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shalvata Mental Health Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing&#xD;
      remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia&#xD;
      outcome remains very limited, mainly due to very poor adherence to medications by the&#xD;
      patients. This study aims to find, whether the add-on of remote monitoring of medication&#xD;
      compliance via tele-medicine, to routine out-patient clinic care, can improve patients&#xD;
      adherence and reduce the risk of relapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing&#xD;
      remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia&#xD;
      outcome remains very limited, mainly due to very poor adherence to medications by the&#xD;
      patients. This study aims to find, whether the add-on of remote monitoring of medication&#xD;
      compliance via tele-medicine, to routine out-patient clinic care, can improve patients&#xD;
      adherence and reduce the risk of relapse. The study is an uni center, open, prospective,&#xD;
      randomised and controlled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to re-hospitalisation</measure>
    <time_frame>1 year</time_frame>
    <description>Time to re-hospitalisation will be compared in the study group and in the control group during the follow-up period of up to one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of re-hospitalisations</measure>
    <time_frame>1 year</time_frame>
    <description>number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total time in hospital</measure>
    <time_frame>1 year</time_frame>
    <description>Total time in hospital during the 1 year follow-up period will be compared between the study and the control groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>Experimental: Tele-medicine monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention: Control Rutine out-patient treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine out-patient treatment will be given to the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tele-medicine monitoring of medication adherence</intervention_name>
    <arm_group_label>Experimental: Tele-medicine monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM 4 diagnosis of schizophrenia or schizoaffective&#xD;
&#xD;
          -  able to give written informed consent&#xD;
&#xD;
          -  Have a telephone line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are not discharged to a place with routine medication monitoring&#xD;
&#xD;
          -  Are not discharged under forced ambulatory treatment order&#xD;
&#xD;
          -  Are not homeless&#xD;
&#xD;
          -  Are not admitted due to drug intoxication or withdrawal.&#xD;
&#xD;
          -  Are not admitted due to severe self harm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Israel Krieger, Dr. Med</last_name>
    <phone>+97297478665</phone>
    <email>israelkr@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shalvata MHC</name>
      <address>
        <city>Hod-Hasharon</city>
        <zip>45100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Israel Krieger, Dr' Med</last_name>
      <phone>+97297478665</phone>
      <email>israelkr@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Israel Krieger, Dr' Med</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>April 24, 2014</last_update_submitted>
  <last_update_submitted_qc>April 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>Schizoaffective Disorder</keyword>
  <keyword>disease management</keyword>
  <keyword>treatment</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>pharmacotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729572
org study id: 0004-12-SHA
nct id: NCT01729572
lead sponsor: 
collaborator: 
has dmc: Yes
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing
      remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia
      outcome remains very limited, mainly due to very poor adherence to medications by the
      patients. This study aims to find, whether the add-on of remote monitoring of medication
      compliance via tele-medicine, to routine out-patient clinic care, can improve patients
      adherence and reduce the risk of relapse.
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing
      remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia
      outcome remains very limited, mainly due to very poor adherence to medications by the
      patients. This study aims to find, whether the add-on of remote monitoring of medication
      compliance via tele-medicine, to routine out-patient clinic care, can improve patients
      adherence and reduce the risk of relapse. The study is an uni center, open, prospective,
      randomised and controlled.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to re-hospitalisation
time frame: 1 year
description: Time to re-hospitalisation will be compared in the study group and in the control group during the follow-up period of up to one year
measure: number of re-hospitalisations
time frame: 1 year
description: number of re-hospitalisations will be compared among the study and the control groups during the 1 year follow-up.
measure: Total time in hospital
time frame: 1 year
description: Total time in hospital during the 1 year follow-up period will be compared between the study and the control groups.
arm group label: Experimental: Tele-medicine monitoring
arm group type: Experimental
description: Tele-medicine monitoring of medication adherence will be given to the study group as an add-on to routine out-patient treatment
arm group label: No Intervention: Control Rutine out-patient treatment
arm group type: No Intervention
description: routine out-patient treatment will be given to the control group
intervention type: Other
intervention name: Tele-medicine monitoring of medication adherence
arm group label: Experimental: Tele-medicine monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Israel Krieger, Dr. Med
phone: +97297478665
email: israelkr@clalit.org.il
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Psychotic Disorders