<?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>IRCT20220130053882N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of transitional care pathway on the outcomes of patients with acute coronary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Transitional Care Pathway on HealthCare Seeking Behaviors, Treatment Adherence, and Care Transition in patients with Acute Coronary Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71462</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In order to prevent the dissemination of information, the method of randomization is time block method. In this way, sampling in the intervention and control groups will be done in the middle of the week. In this way, the first group will be randomly selected by lottery, then the patients who meet the criteria for entering the study will be included in the intervention or control group in the middle of the week. Randomization is such that first a random sequence will be generated for 8 weeks by Randomizer.org and this sequence will be kept in a sealed envelope. At the beginning of each week, the door of the envelope is opened and based on the code in the envelope, all the patients of that week are assigned to the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Angina pectoris. Condition 2: Acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, patients will receive interventions related to the transitional care pathway in addition to routine care after the need for assessment performed by the "Cardiac Disease Need Assessment Form". Interventions of transitional care pathway, which includes care interventions and education, and based on the review of reliable sources and the use of experts' opinions, will begin from the time of admission (emergency/CCU) for the patient after the illness, and according to the time of patient care, during hospitalization (emergency/CCU/I/post-angio). after discharge (telephone or online follow-up at home) will continue. The care and content of this program is provided by the researcher and through oral explanation and presentation of pamphlets, and includes things that use patient hospitalization (such as pain relief, rhythm and hemodynamic monitoring, introduction of the care team, ward and hospital, assessment of patient needs, etc.), treatment of diseases, activity, etc.), discharge time (such as self-care training and monitoring of complications, recognition of danger signs, bathing, prayer, smoking, rest, activity, tests, periodic check-ups, care of devices (such as ICD), coordination with cardiac rehabilitation program, etc.) After discharge, home care is done by phone or online (such as patient status, answering questions, checking side effects, medication side effects, taking medications, observing activity level and diet, rehabilitation status, monitoring ACS side effects, etc.). The frequency of follow-up of patients at home will be once a week by phone and online, and during this period, patients can ask their questions to the researcher. At the time of discharge, the patient will be asked how to communicate online and the communication received (Soroush, Eeta, Gap, Telegram, WhatsApp, etc.). Intervention 2: Control group: Among the control group, the participants will receive standard care designed based on Tuna et al. research in addition to routine care, which includes planned discharge training as well as a manual prepared by the researcher. In the educational program planned for this group, the definition of heart attack, symptoms, treatment goals and risk factors are presented. The training program also contains information about the importance of exercise and nutrition. The training is simple and understandable and the patient is allowed to ask his questions.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirreza Jamshidbeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 96, Fakouri 85, Rezashahr</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176943314</zip>
        <telephone>+98 918 846 0124</telephone>
        <email>jamshidar4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirreza Jamshidbeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 96, Fakouri 85, Rezashahr</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176943314</zip>
        <telephone>+98 918 846 0124</telephone>
        <email>jamshidar4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age more than 18 years
Consent to participate in the study
Hospitalization with diagnosis of acute coronary syndrome (diagnosis confirmed by doctor)
Ability to communicate verbally</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Instability of the patient's clinical condition</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20</hc_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Angina pectoris</hc_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, patients will receive interventions related to the transitional care pathway in addition to routine care after the need for assessment performed by the "Cardiac Disease Need Assessment Form". Interventions of transitional care pathway, which includes care interventions and education, and based on the review of reliable sources and the use of experts' opinions, will begin from the time of admission (emergency/CCU) for the patient after the illness, and according to the time of patient care, during hospitalization (emergency/CCU/I/post-angio). after discharge (telephone or online follow-up at home) will continue. The care and content of this program is provided by the researcher and through oral explanation and presentation of pamphlets, and includes things that use patient hospitalization (such as pain relief, rhythm and hemodynamic monitoring, introduction of the care team, ward and hospital, assessment of patient needs, etc.), treatment of diseases, activity, etc.), discharge time (such as self-care training and monitoring of complications, recognition of danger signs, bathing, prayer, smoking, rest, activity, tests, periodic check-ups, care of devices (such as ICD), coordination with cardiac rehabilitation program, etc.) After discharge, home care is done by phone or online (such as patient status, answering questions, checking side effects, medication side effects, taking medications, observing activity level and diet, rehabilitation status, monitoring ACS side effects, etc.). The frequency of follow-up of patients at home will be once a week by phone and online, and during this period, patients can ask their questions to the researcher. At the time of discharge, the patient will be asked how to communicate online and the communication received (Soroush, Eeta, Gap, Telegram, WhatsApp, etc.).</i_keyword>
      <i_keyword>Control group: Among the control group, the participants will receive standard care designed based on Tuna et al. research in addition to routine care, which includes planned discharge training as well as a manual prepared by the researcher. In the educational program planned for this group, the definition of heart attack, symptoms, treatment goals and risk factors are presented. The training program also contains information about the importance of exercise and nutrition. The training is simple and understandable and the patient is allowed to ask his questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Questionnaire score of health care seeking behaviors. Timepoint: At the time of hospitalization and one month later. Method of measurement: A researcher-made questionnaire of health care seeking behaviors.</prim_outcome>
      <prim_outcome>Questionnaire score of treatment adherence. Timepoint: At the time of hospitalization and one month later. Method of measurement: Ziyai et al. treatment adherence questionnaire.</prim_outcome>
      <prim_outcome>Questionnaire score of Care Transition. Timepoint: one week after discharge. Method of measurement: Care Transition Measure (CTM-15).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-11</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing &amp; Midwifery, Mashhad University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, Mashhad University of Medical Sciences , Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
