<?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>IRCT20180408039238N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-10</date_registration>
      <primary_sponsor>Faculty of nursing and midwifery of Tehran university of medical sciences</primary_sponsor>
      <public_title>The impact of transitional care upon the rate of readmission in patients after Coronary Artery Bypass Graft</public_title>
      <acronym></acronym>
      <scientific_title>The impact of transitional care upon the rate of readmission in patients after Coronary Artery Bypass Graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30552</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random blocking.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary Artery Bypass Graft Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group, patient or his/her home caregiver is trained by researcher about how to keep connection with researcher from home and help tele-nursing. Instructions consists of how to measure body temperature, pulse rate, respiratory rate, blood pressure, efficient using of incentive spirometry, stair workout, walking, appropriate position (sleeping, sitting and during activities), using medications,  assessing and caring sternal or limb incision, measuring weight, warning signs and what to do if those occur, wearing sternal support, suitable diet precautions when taking a bath, praying and during travel. Patient/ home caregiver sends to researcher ,by internet messaging, a report from patient's condition(using the report form designed by researcher) each night in first week after discharge. It is said to patient that she/he can contact researcher by phone call or voice message in case of a new problem or needing to ask question. In case of not sending reports regularly, researcher reminds patient/caregiver by phone call. Researcher contacts patient/home caregiver in case of suspicious conditions and gives some advice or in serious cases recommends patient to return to the initial hospital or first hospital near his/her home. . Researcher does two sessions of home visit ;one in first week after discharge and second session two weeks after first session. In each session, general assessment of patient's state is done, researcher observes implementing instructions by patient and recommends referral to surgeon or other specialists if needed. Patient is recommended to return initial hospital or other hospital in case of occurrence of warning signs between home visit sessions and every other time needed. Intervention 2: Control group: This group will receive rutine care in hospital and after discharge follow ups. Ultimately, researcher will measure 30 day readmission rate in this group and will compare two groups.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is we have not decided about this topic yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnaz Khishvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery,West Nosrat st,Towhid sq, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>M-khishvand@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khatere Seylani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, West Nosrat st, Towhid sq, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>seylanikh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in high risk group according to "30-days readmission score", containing: Diabetes mellitus, haematocrit less than 35 before surgery, Using On-pump technique for surgery, Serum glycemic index  of 200 and more.
Habitation in Tehran our suburbs in first month after discharge to ease the access to patients for  home visits.
Having access to a mobile phone and being able to use mobile and using telegram(patient or his or her home care person) for educational relation and tele- Health
Not having vital organs complicated diseases(motor disfunction, rhumatoid artheritis, CVA,... )
Not having mental diseases(Schisophrenia. psychosis, major depression,...)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness of patient to continue participating in research .
Leaving Tehran and suburbs in less than one month after discharge; because this impedes  home visits.
Hospital stay more than 10 days after CABG surgery leads to omitting the patient from samples.
Patients death during first month after surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T82.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified complication of cardiac and vascular prosthetic device, implant and graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In intervention group, patient or his/her home caregiver is trained by researcher about how to keep connection with researcher from home and help tele-nursing. Instructions consists of how to measure body temperature, pulse rate, respiratory rate, blood pressure, efficient using of incentive spirometry, stair workout, walking, appropriate position (sleeping, sitting and during activities), using medications,  assessing and caring sternal or limb incision, measuring weight, warning signs and what to do if those occur, wearing sternal support, suitable diet precautions when taking a bath, praying and during travel. Patient/ home caregiver sends to researcher ,by internet messaging, a report from patient's condition(using the report form designed by researcher) each night in first week after discharge. It is said to patient that she/he can contact researcher by phone call or voice message in case of a new problem or needing to ask question. In case of not sending reports regularly, researcher reminds patient/caregiver by phone call. Researcher contacts patient/home caregiver in case of suspicious conditions and gives some advice or in serious cases recommends patient to return to the initial hospital or first hospital near his/her home. . Researcher does two sessions of home visit ;one in first week after discharge and second session two weeks after first session. In each session, general assessment of patient's state is done, researcher observes implementing instructions by patient and recommends referral to surgeon or other specialists if needed. Patient is recommended to return initial hospital or other hospital in case of occurrence of warning signs between home visit sessions and every other time needed.</i_keyword>
      <i_keyword>Control group: This group will receive rutine care in hospital and after discharge follow ups. Ultimately, researcher will measure 30 day readmission rate in this group and will compare two groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Readmission rate after discharge from hospital following Coronary artery bypass graft surgery. Timepoint: At the end of 30th day after discharge from hospital, readmission rate in groups (intervention and control) is measured. Method of measurement: Asking patient and studying patient's case.</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>Faculty of nursing and midwifery of Tehran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-31</approval_date>
        <contact_name>Ethics committee of faculty of Nursing and Midwifery of Tehran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery , Dr. Mirkhani St (Nosrat St) ,Towhid sq,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
