<?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>IRCT20230717058816N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>the effect of hospital readmission reduction  program on heart failure patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Hospital Readmissions Reduction Program on knowledge, self-care behaviors, 30-day readmission rate on heart failure patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71639</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failur.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Education to the patient and family: At first, a needs assessment of the patients about the disease and the required educational materials will be done. The training of patients in the intervention group and their families during hospitalization and before discharge will be individual and together with their families .which will focus on learning patients about diet, daily weighing, medications, permitted and unauthorized activities, and smoking cessation. Trainings will be conducted by nurses working in health education nursing clinic. The trainings will be provided to these patients in two 30-minute sessions individually with their families. In order to prepare these nurses, a two-hour training session will be held with an emphasis on the educational needs of heart failure patients and the introduction of educational content in this regard. The educational contents of the patients including educational pamphlets (at least 4 pamphlets) and an educational video will be prepared by the researcher and will be provided to the patients. At the end, the guide form for monitoring the symptoms of the disease by the patient will be presented to the patient and the family. Intervention 2: Control group: In this research, the control group will receive the usual training of the department, which includes the training codes in the training sheet about heart failure disease, which has been in the hospital before.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Solmaz  Ghebleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East gate of Ferdowsi University of Mashhad ،Azadi Square، university campus, educational complex of Shahid Dr.  Kharazmi ،university campus, educational complex of Shahid Dr. Kharazmi، Khorasan  Razavi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>098 51 38591511-3</telephone>
        <email>nms.pr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>HeshmatiNabavi Fatemeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East gate of Ferdowsi University of Mashhad ،Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،university campus, educational complex of Shahid Dr. Kharazmi، Khorasan Razavi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>098 51 38591511-3</telephone>
        <email>heshmatinf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with heart failure confirmed by their doctor.
The age of patients should be between 18 years and older
Having complete consent that is oral and written
patients who go home after discharge.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are in critical condition and are hospitalized in special departments.
The patient's unwillingness to continue the study.
patients who do not go home after discharge</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Education to the patient and family: At first, a needs assessment of the patients about the disease and the required educational materials will be done. The training of patients in the intervention group and their families during hospitalization and before discharge will be individual and together with their families .which will focus on learning patients about diet, daily weighing, medications, permitted and unauthorized activities, and smoking cessation. Trainings will be conducted by nurses working in health education nursing clinic. The trainings will be provided to these patients in two 30-minute sessions individually with their families. In order to prepare these nurses, a two-hour training session will be held with an emphasis on the educational needs of heart failure patients and the introduction of educational content in this regard. The educational contents of the patients including educational pamphlets (at least 4 pamphlets) and an educational video will be prepared by the researcher and will be provided to the patients. At the end, the guide form for monitoring the symptoms of the disease by the patient will be presented to the patient and the family.</i_keyword>
      <i_keyword>Control group: In this research, the control group will receive the usual training of the department, which includes the training codes in the training sheet about heart failure disease, which has been in the hospital before.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care behaviors. Timepoint: Self-care behaviors will be measured before the intervention and one month after the intervention. Method of measurement: How to measure the self-care variable will be measured with Rachel et al.'s self-care questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge. Timepoint: At the beginning of the study, the knowledge variable will be measured and one month after the study, the knowledge of patients with heart failure will be measured. Method of measurement: The method of measuring  the knowledge of heart failure patients is with the Dutch knowledge questionnaire, and the knowledge of the patients will be measured before the intervention and one month later.</sec_outcome>
      <sec_outcome>30-day readmission rate of patients. Timepoint: The 30-day readmission rate of patients will be measured one month after the intervention. Method of measurement: The method of measuring the rate of re-hospitalization is that one month after the intervention, it will be done by asking the patients and companions if they were hospitalized in Imam Reza Hospital or any other medical hospital and it will be measured quantitatively.</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>2023-08-15</approval_date>
        <contact_name>Ethics Committee, Mashhad University of Nursing and Midwifery</contact_name>
        <contact_address>east gate of Ferdowsi University of Mashhad، Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،Khorasan Razavi, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
