<?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>IRCT20251119068047N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-08</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of implementing transitional nursing care in the elderly undergoing coronary artery bypass graft surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of the transitional nursing care on functional independence, quality of life, and cardiac self-efficacy of the elderly undergoing coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87659</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be allocated to the intervention or control group using block randomization. The random allocation sequence will be generated by the third researcher using the online tool available at www.random.org/sequences/
. This sequence will then be placed as coded assignment labels inside 70 opaque, sealed envelopes. The allocation order will only be revealed upon opening each envelope at the time of a participant’s entry into the study. In this way, allocation concealment is ensured, minimizing the risk of selection bias.

To prevent contamination between the two study groups, patients in the control and intervention groups will be accommodated in separate rooms from admission until discharge. Additionally, participants in the intervention group will be instructed not to share any educational materials with other patients during the study period. Patients and their companions will be reminded not to disclose the educational content or study procedures to other patients, especially to those who are candidates for CABG surgery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic ischemic coronary artery disease. Condition 2: Patients undergoing coronary artery bypass surgery. Condition 3: Transitional nursing care of patients undergoing coronary artery bypass surgery. Condition 4: Nursing-led multidisciplinary care for patients undergoing coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The structured transitional nursing care intervention for the intervention group is delivered over four phases during 16 weeks. Before surgery, patients and one family member receive a validated multimedia CABG educational package consisting of seven short (5–10 minute) videos delivered via smartphone messenger or in-person, covering surgical preparation, procedure stages, hospital care, symptom monitoring, self-assessment, and post-discharge self-care. In the first week post-surgery (in-hospital and immediate post-discharge phase), the lead nurse conducts face-to-face consultation, assesses living conditions, support systems and medication adherence, reviews the educational package and answers questions while the surgeon performs clinical follow-up, the dietitian provides nutritional counseling, and the physiotherapist teaches rehabilitation exercises. From weeks 2 to 8 post-surgery, the lead nurse performs scheduled telephone follow-ups at weeks 2, 4, 6, and 8, reinforces self-care education, completes specific home-care follow-up forms, and refers patients to the multidisciplinary team as needed. From weeks 12 to 16, telephone follow-ups continue at weeks 12, 14, and 16 to monitor rehospitalization, complications, medication continuity, and medical visits, with completion of general follow-up forms and referral when necessary. All activities are coordinated by the coordinating nurse under the supervision of the principal investigator (lead nurse), and research instruments are completed at baseline, week 8, and week 16. Intervention 2: Control group: The control group receives routine hospital and cardiac rehabilitation center care, including pre-operative psychological counseling, general post-operative education in the ward, and telephone follow-up at one month and one year by the rehabilitation center. No additional research intervention is provided; participation in routine programs is only recommended.</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 participant personal data in the study can be shared after anonymization. Data sharing can be done by uploading to official data repositories or upon request by the applicant via email to the corresponding author.

When:
6 months after publication of the article

To whom:
The data will be available to researchers working in universities and scientific institutions.

Conditions:
For scientific application and use for systematic review studies

Where to obtain:
Fatemeh Bakhshi, Yazd, Bouali St., Safaieh, Shahid Sadoughi Nursing and Midwifery School, Yazd, Nursing and Midwifery Care Research Center, Postal Code: 8916877443, Contact Phone: 00989139684626, Email Addresses: fateme.bakhshii@gmail.com - f.bakhshi@ssu.ac.ir

How to obtain:
One week after the applicant's email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Bu Ali Street, Opposite the Infertility Center</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>fateme.bakhshii@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Bu Ali Street, Opposite the Infertility Center</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>fateme.bakhshii@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Young elders (age group 60 to 75 years)
Being alert and mentally healthy
Performing coronary artery bypass grafting for the first time
The patient's coronary artery bypass grafting procedure is not an emergency.
No history of mental disorder
The patient or their active companion must be literate.
The patient or their active companion must have a smartphone and the patient or their companion must be able to use the internet.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient's condition should be such that he/she is unable to visit in person, especially in the first two weeks, and this should be mentioned from the beginning.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
      <hc_code>T82.9</hc_code>
      <hc_code>Z74.3</hc_code>
      <hc_code>Z51.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischaemic heart disease</hc_keyword>
      <hc_keyword>Unspecified complication of cardiac and vascular prosthetic device, implant and graft</hc_keyword>
      <hc_keyword>Need for continuous supervision</hc_keyword>
      <hc_keyword>Encounter for other specified aftercare</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The structured transitional nursing care intervention for the intervention group is delivered over four phases during 16 weeks. Before surgery, patients and one family member receive a validated multimedia CABG educational package consisting of seven short (5–10 minute) videos delivered via smartphone messenger or in-person, covering surgical preparation, procedure stages, hospital care, symptom monitoring, self-assessment, and post-discharge self-care. In the first week post-surgery (in-hospital and immediate post-discharge phase), the lead nurse conducts face-to-face consultation, assesses living conditions, support systems and medication adherence, reviews the educational package and answers questions while the surgeon performs clinical follow-up, the dietitian provides nutritional counseling, and the physiotherapist teaches rehabilitation exercises. From weeks 2 to 8 post-surgery, the lead nurse performs scheduled telephone follow-ups at weeks 2, 4, 6, and 8, reinforces self-care education, completes specific home-care follow-up forms, and refers patients to the multidisciplinary team as needed. From weeks 12 to 16, telephone follow-ups continue at weeks 12, 14, and 16 to monitor rehospitalization, complications, medication continuity, and medical visits, with completion of general follow-up forms and referral when necessary. All activities are coordinated by the coordinating nurse under the supervision of the principal investigator (lead nurse), and research instruments are completed at baseline, week 8, and week 16.</i_keyword>
      <i_keyword>Control group: The control group receives routine hospital and cardiac rehabilitation center care, including pre-operative psychological counseling, general post-operative education in the ward, and telephone follow-up at one month and one year by the rehabilitation center. No additional research intervention is provided; participation in routine programs is only recommended.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health-Related Quality of Life. Timepoint: The time points for measuring quality of life in this study include: at the beginning of the study (before surgery), the end of the eighth week after the start of the study (end of intervention phase), and the end of the sixteenth week after the start of the study (end of follow-up phase). Method of measurement: SF-36 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospital Readmission. Timepoint: The time points for measuring hospital readmissions in this study include: at the beginning of the study (before surgery), the end of the eighth week after the start of the study (end of intervention phase), and the end of the sixteenth week after the start of the study (end of follow-up phase). Method of measurement: Follow up form.</sec_outcome>
      <sec_outcome>Cardiac Self-Efficacy. Timepoint: The time points for measuring Cardiac Self-Efficacy in this study include: at the beginning of the study (before surgery), the end of the eighth week after the start of the study (end of intervention phase), and the end of the sixteenth week after the start of the study (end of follow-up phase). Method of measurement: Cardiac self-efficacy scale.</sec_outcome>
      <sec_outcome>Functional Independence. Timepoint: The time points for measuring functional independence in this study include: at the beginning of the study (before surgery), the end of the eighth week after the start of the study (end of intervention phase), and the end of the sixteenth week after the start of the study (end of follow-up phase). Method of measurement: Barthel scale.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-17</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Imam Reza Complex, Imam Hossein Square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
