<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201110261959N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-19</date_registration>
      <primary_sponsor>Mental Health Research Center</primary_sponsor>
      <public_title>Treatment follow up of severe and chronic Mentally ill patients</public_title>
      <acronym></acronym>
      <scientific_title>Survey of efficacy and effectiveness of after discharge services and severe and chronic patients phone call follow up performed by the nursing staff</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1560</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: schizophrenia. Condition 2: schizoaffective disorder. Condition 3: bipolar affective disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groups,calling case managers,include nurses and phone following.The participants recieve home-visit by a case-manager monthly for 12 consecutive months.The first group include nurses.They supervise the patient's drug treatment according to the patient's psychiatrist prescription,train the patient and her/his caregivers according to 12-month topics, report the patients mental status/drug side effects to the psychiatrist.In the second group, by having a phone call, patient have been recalled for their next visit in the clinic.The control group is the third group that receives the treatment facilities which are available "as usual services" from society.they are contacted by telephone each 3-month to complete the cost questionnaire. Intervention 2: In the control group no intervention will be provided.They are contacted by telephone each 3-month to complete the cost questionnaire and asking probability of addmition at 3-month ago.The patients receives the treatment facilities which are available"as usual services" from society.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Seyed Kazem Malakouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansuri St. Niayesh St. Sattarkhan Ave. Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1443813444</zip>
        <telephone>+98 21 6655 0200</telephone>
        <email>sk-malakouti@tums.ac.ir</email>
        <affiliation>Tehran university of medical sience-Tehran psychiatric Institude</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Seyed Kazem Malakouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansuri St. Niayesh St. Sattarkhan Ave. Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1443813444</zip>
        <telephone>+98 21 6655 0200</telephone>
        <email>sk-malakouti@tums.ac.ir</email>
        <affiliation>Tehran university of medical siences-Tehran psychiatric Institude</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:presence of schizophrenia or bipolar spectrum disorders,age 15-60 years old,having at least one hospitalization history for exacerbation in her/his past history,need for aftercare services according to her/his psychiatric due to low level of compliance &#13;
Exclusion criteria: having organic brain disorder,having cuncurrently substance use disorders, using similar services from other sources</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
      <hc_code>F25</hc_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
      <hc_keyword>Schizoaffective disorders</hc_keyword>
      <hc_keyword>Bipolar affective disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groups,calling case managers,include nurses and phone following.The participants recieve home-visit by a case-manager monthly for 12 consecutive months.The first group include nurses.They supervise the patient's drug treatment according to the patient's psychiatrist prescription,train the patient and her/his caregivers according to 12-month topics, report the patients mental status/drug side effects to the psychiatrist.In the second group, by having a phone call, patient have been recalled for their next visit in the clinic.The control group is the third group that receives the treatment facilities which are available "as usual services" from society.they are contacted by telephone each 3-month to complete the cost questionnaire.</i_keyword>
      <i_keyword>In the control group no intervention will be provided.They are contacted by telephone each 3-month to complete the cost questionnaire and asking probability of addmition at 3-month ago.The patients receives the treatment facilities which are available"as usual services" from society.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Relapse and rehospitalization due to exacerbation of disorder. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: observing the course of disease.</prim_outcome>
      <prim_outcome>Caregiver's knowledge. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: caregiver's knowledge questionnaire.</prim_outcome>
      <prim_outcome>Caregiver's burden. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: family burden interview scale.</prim_outcome>
      <prim_outcome>Health of caregiver. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: general health questionnaire.</prim_outcome>
      <prim_outcome>Patient's satisfaction from services. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: client satisfaction questinnaire-8.</prim_outcome>
      <prim_outcome>Patient's quality of life. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: guality of life questionnaire-36.</prim_outcome>
      <prim_outcome>Cost of treatment,cost-effective of evaluation. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: cost questionnaire.</prim_outcome>
      <prim_outcome>Life skills of patients. Timepoint: at the biginning and after 12 months of inervention. Method of measurement: KELZ life skill scale.</prim_outcome>
      <prim_outcome>Severity of psychopathology. Timepoint: before and after one year of intervention. Method of measurement: Young Mania Rating Scale(YMRS), Positive and Negetive Syndrome Scale(PANSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Beheshti University of Medical Sience</sponsor_name>
      <sponsor_name>Tehran(Pardise Hemat) University of Medical Sience</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mental Health Research Center</source_name>
      <source_name>Shahid Beheshti University of Medical Sience</source_name>
      <source_name>Tehran(Pardise Hemat) University of Medical Sience</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-06-15</approval_date>
        <contact_name>Rechearch Cernter of Shahid Beheshti University of Medical Sience</contact_name>
        <contact_address>near of Taleghani Hospital, Evin, Chamran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
