<?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>IRCT20101019004971N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-09</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey of the Impact of a nurse-led home- based self- care program on Quality Of Life and physiological indicators of Heart Failure patients</public_title>
      <acronym>nurse-led home- based self- care program</acronym>
      <scientific_title>Survey of the Impact of a nurse-led home- based self- care program on Quality Of Life and physiological indicators of Heart Failure patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69831</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All eligible people will be divided equally (ratio 1:1) into two groups of self-care program at home under the guidance of a nurse and control using the block randomization method with the size of 4 and 6 blocks.
Sealed Envelope Ltd online randomization service and random sequence sealed opaque envelopes (SNOSE) will be used to generate the randomization list.</study_design>
      <phase>2</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: self-care program at home under the guidance of a nurse. the intervention is carried out in two stages before discharge and after discharge Pre-discharge intervention in the form of nurse-centered self-care programs training in seven areas, which include 1- identifying dangerous symptoms of the disease and consulting symptoms and tests, 2- drug regimen, 3- diet, 4- activity and sports activity, 5- control stress and anxiety, 6- education about sexual issues and 7- life style modification, In the intervention group, after stabilization of the clinical condition and on day of discharge will be given. And an educational booklet focusing on the mentioned topics is also given to the patients on the day of discharge Also, post-discharge training will be repeated for this  group patients through telephone calls, weekly for eight weeks and with the training of one area of ​​the mentioned training program (except for the last week). Intervention 2: Control group: Patients with heart failure who will only receive routine interventions based on hospital guidelines.</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 Considering that the collected data is used only for this study, its confidentiality will be maintained and will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Taghi Moghaddamnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Highway, Shahid Beheshti College of Nursing and Midwifery</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939814</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>Moghadamnia@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Taghi Moghaddamnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Highway, Student Street, Shahid Beheshti College of Nursing and Midwifery</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939814</zip>
        <telephone>+98 13 3355 3302</telephone>
        <email>moghadamnia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be in the age range of 20-70 years.
With the diagnosis of heart failure, they should not be candidates for heart surgery.
According to the International Classification of Diseases (ICD), fall into the category of heart failure.
According to the NYHA classification, they are classified as II-III heart failure.
have not participated in another research project with this content
The area of ​​their residence should be the city of Rasht and its suburbs.
In terms of the history of suffering from the disease, they should be in the weak classification of the Charleston criterion. (This criterion has three classifications: weak, moderate and severe).</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Be in the age range of under 20 years and over 70 years
According to the NYHA classification, they are classified as I and IV heart failure
In terms of history of suffering from the disease, they should be in the moderate and severe classification of the Charleston criteria.(This criterion has three classifications: weak, moderate and severe).
The living area of ​​the patients should be outside the city of Rasht and its suburbs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac, heart or myocardial failure NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: self-care program at home under the guidance of a nurse. the intervention is carried out in two stages before discharge and after discharge Pre-discharge intervention in the form of nurse-centered self-care programs training in seven areas, which include 1- identifying dangerous symptoms of the disease and consulting symptoms and tests, 2- drug regimen, 3- diet, 4- activity and sports activity, 5- control stress and anxiety, 6- education about sexual issues and 7- life style modification, In the intervention group, after stabilization of the clinical condition and on day of discharge will be given. And an educational booklet focusing on the mentioned topics is also given to the patients on the day of discharge Also, post-discharge training will be repeated for this  group patients through telephone calls, weekly for eight weeks and with the training of one area of ​​the mentioned training program (except for the last week).</i_keyword>
      <i_keyword>Control group: Patients with heart failure who will only receive routine interventions based on hospital guidelines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physiological indicators (systolic blood pressure, pulse rate, breathing rate, arterial blood oxygen saturation level). Timepoint: The measurement of this index is done before the discharge of the patients and eight weeks after the intervention. Method of measurement: The method of measurement is by using a mercury sphygmomanometer and a pulse oximetry device and paying attention to the up and down movements of the chest.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General quality of life. Timepoint: This index will be done before the discharge of the patients and eight weeks after the discharge of the patients and one month after the completion of the intervention. Method of measurement: Measuring the general quality of life will be done using a 12-question general quality of life questionnaire.</sec_outcome>
      <sec_outcome>Specific quality of life. Timepoint: This index will be done before the discharge of the patients and eight weeks after the discharge of the patients and one month after the completion of the intervention. Method of measurement: Specific quality of life measurement will be done using the Minnesota Heart Failure Questionnaire.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-19</approval_date>
        <contact_name>Ethics committee of guilan university of medical sciences</contact_name>
        <contact_address>Shahid Beheshti Highway, Student Street, Shahid Beheshti College of Nursing and Midwifery Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
