<?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>IRCT2015021321056N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-02</date_registration>
      <primary_sponsor>Vice President of Research and Technology, University of Ahvaz</primary_sponsor>
      <public_title>Self care in patients with hepatitis B</public_title>
      <acronym></acronym>
      <scientific_title>Effect of "professional partnership centered care," the self-care behavior in patients with hepatitis B</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18546</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hepatitis B.</hc_freetext>
      <i_freetext>Intervention 1: Patients in intervention group will receive 4 sessions training, each session lasting 50 minutes. The education team includes researchers, a nurse of gastroenterology and three of the patients with hepatitis B, that knowledge are higher than other patients. Education is about the illness and self-care behaviors. Based on the needs of patients the number and duration of sessions increases. Patients are evaluated after 2 weeks, if necessary training sessions will be repeated and to be empowered patients about self-care behaviors. Intervention 2: Patients in the control group will receive routine hospital training.</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>Fateme Hardani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6177613616</zip>
        <telephone>+98 61 3228 2838</telephone>
        <email>hardani.f@ajums.ac.ir  f.hardani7777@gmail.com</email>
        <affiliation>Ahvaz Jundishapor University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Elahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3373 8333</telephone>
        <email>Elahi_118@yahoo.com       Elahi-N@ajum.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. Patients with chronic hepatitis B by a specialist (at least the last 6 months of diagnosis.) Is confirmed. 2. Age over 18 years old. 3. Having the opportunity to attend training sessions or residing in Ahvaz. 4. literacy. 5. No risk of liver cancer and advanced cirrhosis. 6. In terms of mental and physical fitness have participated in training sessions. 7. The presence of a companion (who lives and works with the patient's follow-up treatment) in all training sessions.&#13;
Exclusion criterion: Participate in training sessions (two sessions of absenteeism and more)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B18.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic viral hepatitis B without delta-agent      Chronic (viral) hepatitis B</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in intervention group will receive 4 sessions training, each session lasting 50 minutes. The education team includes researchers, a nurse of gastroenterology and three of the patients with hepatitis B, that knowledge are higher than other patients. Education is about the illness and self-care behaviors. Based on the needs of patients the number and duration of sessions increases. Patients are evaluated after 2 weeks, if necessary training sessions will be repeated and to be empowered patients about self-care behaviors.</i_keyword>
      <i_keyword>Patients in the control group will receive routine hospital training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self care. Timepoint: Before the experiment, 4 weeks after the intervention. Method of measurement: Self-care questionnaire in patients with hepatitis B.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice President of Research and Technology, University of Ahvaz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-17</approval_date>
        <contact_name>Ahvaz Jundishapor University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Ethics Committee, vice-chancellor for research and technology, Jundishapur University of Medical Sciences, Golestan street, Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
