<?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>IRCT20180903040938N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-17</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of structured education and post-discharge follow-up on the incidence of early complications and mortality after open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of structured education and post-discharge follow-up on the incidence of early complications and mortality after open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53472</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random time block: In order to prevent patients from contacting each other and exchanging information between them, a random sequence of two-week time blocks will be randomly determined through SPSS software. The sequence is kept in a sealed envelope and when opened every two weeks, it is determined which intervention should be performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>open heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educational content prepared from reputable sources such as Clinical key, Medline plus and nursing consult after approval by experts in this field (nurses and physicians working in open heart surgery) based on the average number of days of hospitalization of these patients in the ward with the titles of initial admission Ward, general rules of the ward, how to wash hands properly, introduction of staff and how to use the nurse summons, the nature of the disease and the cause of hospitalization, methods of diagnosis and treatment of the disease, preparations before open heart surgery, postoperative care Open heart surgery, physical activity, diet, constipation prevention, on-site care, medication regimen and on-the-go training will be provided in each shift from admission to discharge. The presentation method includes lectures, showing pictures and related videos and presenting a pamphlet containing a summary of the content presented in each shift, and after the training, the patient and his caregiver will understand the training provided with open-ended questions. Also, before presenting each training, the patient's understanding of the training provided in the previous shift will be measured by asking questions and will be reviewed if necessary. After the patient's discharge, a telephone call (with a maximum time of 15 minutes) will be made to follow up on the patient's condition, remind them of the issues mentioned at the time of admission and answer possible questions on a specific day and according to the previously coordinated time with patients / their caregivers. Also, the contact number of the department will be provided to them to answer the questions. The condition of the patients will be followed up (telephone-doctor's visit) up to 3 months after discharge. Intervention 2: Control group: Get routine care in the ward.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Participants' information will be kept confidential and the results will be presented without mentioning the names of the individuals.

When:
After printing the results

To whom:
Everyone

Conditions:
By respecting literary rights and trust

Where to obtain:
Birjand University of Medical Sciences

How to obtain:
After reviewing the application, within a maximum of one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Nikraftar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ghaffari street, Birjand University of Medical Sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 56 3238 1210</telephone>
        <email>Nikraftarf1992@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Nikraftar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari street, Birjand University of Medical Sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 56 3238 1210</telephone>
        <email>Nikraftarf1992@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Literacy
Ability to make phone calls</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>receive additional training
speech and hearing problems
Being a member of a health team
history of heart surgery
history of stroke
history of disease-related complications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I23.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other current complications following acute myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Educational content prepared from reputable sources such as Clinical key, Medline plus and nursing consult after approval by experts in this field (nurses and physicians working in open heart surgery) based on the average number of days of hospitalization of these patients in the ward with the titles of initial admission Ward, general rules of the ward, how to wash hands properly, introduction of staff and how to use the nurse summons, the nature of the disease and the cause of hospitalization, methods of diagnosis and treatment of the disease, preparations before open heart surgery, postoperative care Open heart surgery, physical activity, diet, constipation prevention, on-site care, medication regimen and on-the-go training will be provided in each shift from admission to discharge. The presentation method includes lectures, showing pictures and related videos and presenting a pamphlet containing a summary of the content presented in each shift, and after the training, the patient and his caregiver will understand the training provided with open-ended questions. Also, before presenting each training, the patient's understanding of the training provided in the previous shift will be measured by asking questions and will be reviewed if necessary. After the patient's discharge, a telephone call (with a maximum time of 15 minutes) will be made to follow up on the patient's condition, remind them of the issues mentioned at the time of admission and answer possible questions on a specific day and according to the previously coordinated time with patients / their caregivers. Also, the contact number of the department will be provided to them to answer the questions. The condition of the patients will be followed up (telephone-doctor's visit) up to 3 months after discharge.</i_keyword>
      <i_keyword>Control group: Get routine care in the ward</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of complications and mortality. Timepoint: At the beginning of the study and 3 months after the intervention. Method of measurement: Complication checklist.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-12</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>ghaffari street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
