<?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>IRCT20241208063990N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-14</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>A study of a new training for preparing cardiac patients before discharge after open heart surgery.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Educational Intervention Based on Transition Theory on the Readiness for Hospital Discharge in Patients Undergoing Open Heart Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80651</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: In this study, a block randomization method will be used to allocate patients to intervention and control groups. Initially, using random number generator software, blocks of size 4 will be created, consisting of combinations of intervention (I) and control (C) groups (such as IICC, ICIC, CCII). These blocks will be randomly arranged to create the final group allocation list. Each eligible patient entering the study will be assigned to either the intervention or control group in order from this randomized list. To maintain allocation concealment, sealed and numbered envelopes will be used. The person responsible for group allocation will not be involved in outcome assessment to ensure blinding. This method ensures that the number of participants in each group is balanced and minimizes the possibility of predicting group allocations, thereby increasing the internal validity of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Patients who are candidates for heart surgery at Baqiyatallah Hospital will be randomly selected to participate in the study. They will receive education over five days through in-person sessions, structured step-by-step based on the Transition Theory as follows: Session One (Day before surgery): To assess patient awareness, patients will complete an anxiety questionnaire and a readiness for discharge survey. Session Two (60-minute group session on the second day after surgery): Face-to-face education based on identified educational needs from reviewing literature on patient awareness, engagement, and participation. Education continues until patients demonstrate independence. Session Three (60-minute group session on the third day after surgery): Focuses on patient engagement and participation during the transition period to another ward. Feedback is provided on previously taught lessons, with additional instruction if needed. Patients are encouraged mentally to continue learning as they move wards. Session Four (15-20 minute individual or family interview): Considering critical aspects when preparing patients for home transfer, encouraging adherence to care plans taught earlier, motivating families to create a stress-controlled environment, monitoring medication intake. Session Five (Phone follow-up): Focusing on event aspects by contacting patients and their families two weeks post-discharge to review dietary and medication adherence; completing a medication regimen compliance questionnaire. This structured approach aims to enhance patient recovery through comprehensive support throughout their transition from hospital care back home. Intervention 2: In the control group, patients who are candidates for heart surgery are randomly assigned to the control group and receive routine hospital care.</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:
All questionnaire questions, including researcher-made variables and scores of the questionnaires used, are available.

When:
Immediately after the article was published

To whom:
Researchers, professors and students of medical universities and healthcare workers

Conditions:
The results of this study can be used in medical centers to improve the health of patients and to benefit the educational system.

Where to obtain:
University Library, Published Article

How to obtain:
The request is sent via email or other means of communication to the responsible author or colleagues, and then the required information is made available to the applicants.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square, Mulla Sadra Street, Sheikh Bahai Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 9800</telephone>
        <email>hashemisaeed65@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square, Mulla Sadra Street, Sheikh Bahai Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 9800</telephone>
        <email>hashemisaeed65@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No history of previous open heart surgery
Age 30 to 75 years
Willingness to participate in an educational session
Literacy
No history of psychological disorders</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of open heart surgery
Simultaneous participation in another study with similar educational content
Deterioration of the patient's condition and return to the intensive care unit</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients who are candidates for heart surgery at Baqiyatallah Hospital will be randomly selected to participate in the study. They will receive education over five days through in-person sessions, structured step-by-step based on the Transition Theory as follows: Session One (Day before surgery): To assess patient awareness, patients will complete an anxiety questionnaire and a readiness for discharge survey. Session Two (60-minute group session on the second day after surgery): Face-to-face education based on identified educational needs from reviewing literature on patient awareness, engagement, and participation. Education continues until patients demonstrate independence. Session Three (60-minute group session on the third day after surgery): Focuses on patient engagement and participation during the transition period to another ward. Feedback is provided on previously taught lessons, with additional instruction if needed. Patients are encouraged mentally to continue learning as they move wards. Session Four (15-20 minute individual or family interview): Considering critical aspects when preparing patients for home transfer, encouraging adherence to care plans taught earlier, motivating families to create a stress-controlled environment, monitoring medication intake. Session Five (Phone follow-up): Focusing on event aspects by contacting patients and their families two weeks post-discharge to review dietary and medication adherence; completing a medication regimen compliance questionnaire. This structured approach aims to enhance patient recovery through comprehensive support throughout their transition from hospital care back home.</i_keyword>
      <i_keyword>In the control group, patients who are candidates for heart surgery are randomly assigned to the control group and receive routine hospital care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score obtained using the Readiness for Discharge Scale. Timepoint: Before the intervention and two months after surgery. Method of measurement: Score obtained from the Morisky questionnaire.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-03</approval_date>
        <contact_name>Ethical Committee of Baqiyatallah Al-Azam Educational and Therapeutic Center</contact_name>
        <contact_address>No. 150, West Brazil Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
