<?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>IRCT2017072835350N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-23</date_registration>
      <primary_sponsor>College of Nursing and Midwifery,   Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care program based on Orem's theory on the performance and quality of life of schizophrenic patients</public_title>
      <acronym></acronym>
      <scientific_title>study of  The effect of a self-care program based on Orem's theory on the performance and quality of life of schizophrenic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26734</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia disorder.</hc_freetext>
      <i_freetext>The researcher will set up his intervention program based on the Orem-based self-care plan and will act as a supportive educational intervention in eight 90-minute sessions, twice a week for patients with schizophrenia, who have criteria Clearance and Eligibility..</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>Saeed Pahlavanzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi  Square, Hezarjarib street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3668 7124</telephone>
        <email>pahlavanzadeh@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Khalatbari Zamanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Sadough shomali Street,Khorram Alley , No. 33 Floor 3rd Floor</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8163836951</zip>
        <telephone>+98 31 3663 8424</telephone>
        <email>s.khalatbari@nm.mui.ac.irkhalatbaris@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery</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>Criteria for entering the study:&#13;
1. Have at least 2 years of history of chronic schizophrenia.&#13;
2. Have a willingness to participate in the research.&#13;
3-Minimum age for participation in the research is 18 years and maximum 50 years. (Jahansari et al., 2011)&#13;
4. Be able to communicate and read and write in Persian.&#13;
5-Examples have the ability to understand the content provided in the training classes (according to the psychiatrist's approved insight) and have the consent to participate in the study. (Jansari et al., 2011)&#13;
6. The selected samples are admitted to hospital and have criteria for discharge (criteria for returning to society) according to the psychiatrist.&#13;
7. Confirmation of the diagnosis of schizophrenia by a psychiatrist based on DSM-5 criteria in the chronic phase of the disease. (Jansari et al., 2011)&#13;
8. Do not have drug addiction and do not treat psychosocial drugs.&#13;
9.Do not Have participated in any training project in this area before.&#13;
10-Do not have physical features that cause a functional impairment.&#13;
Exit criteria:&#13;
1-The inability of a regular company to attend meetings (having more than two meetings absent)&#13;
2. The patient does not want to continue co-operation in educational sessions.&#13;
3. Suicide or death during the study.&#13;
4. The occurrence of stressful events in divorce and suicide is such that the level of their stress and anxiety according to the Holmes table and Rahe to patients during the study is more than 150.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The researcher will set up his intervention program based on the Orem-based self-care plan and will act as a supportive educational intervention in eight 90-minute sessions, twice a week for patients with schizophrenia, who have criteria Clearance and Eligibility.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Overall performance. Timepoint: Before the intervention, one month later and three months after the intervention. Method of measurement: General Performance Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life in Schizophrenic Patients. Timepoint: Before the intervention, one month later and three months after the intervention. Method of measurement: The quality of life questionnaire for schizophrenic patients.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>IR.MUI.REC.1396.3.210</sec_id>
        <issuing_authority>Isfahan University of Medical Sciences, College of Nursing and Midwifery</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>College of Nursing and Midwifery,   Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>College of Nursing and Midwifery, Isfahan University of Medical Sciences</contact_name>
        <contact_address>Azadi Square, Hezarjarib street Esfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>College of Nursing and Midwifery, Isfahan University of Medical Sciences</contact_name>
        <contact_address>Azadi Square, Hezarjarib street Esfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>College of Nursing and Midwifery, Isfahan University of Medical Sciences</contact_name>
        <contact_address>Azadi Square, Hezarjarib street Esfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
