<?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>IRCT20220612055150N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of individually designed education on empowerment of heart failure patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of individually designed energy conservation training on self-care empowerment and quality of life of patients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization of 4 pieces, we have 6 blocks of 4 pieces, which according to the sample size, we randomly select 17 times from these 6 blocks. In the 4 pieces blocks, A is the intervention group and B is the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For patients in the intervention group, 4  face-to-face training sessions of 30 minutes will be conduced for each person every 3 weeks.(The first session, The third week ,The six week and the ninth week will be in the CCU, cardiology department or outpatient cardiology clinics).In the first session, prioritized trainings will be provided for each patient based on the needs assessment obtained from the information of the  questionnaires in the form of face-to-face training and questions and answers. At the end of the first session, patients are emphasized on registering edema in the lower extremities, number of times sitting during the day, recording posture after doing housework, walking, climbing stairs, sleeping position, performing daily activities, recording shortness of breath, anxiety And depression in the notebook and present it to the next session or send via SMS to the researcher. In this case, the patient is encouraged to perform self-monitoring actions and doing these things becomes a daily routine for the patient and his family. In the second, third and fourth sessions, according to the patient's records of his condition, the trainings will be repeated in the areas required by the patient and the patient's possible questions will be answered. Intervention 2: Control group: Patients of the control group will receive routine nursing training after discharge or routine clinic training.</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:
Individual data of participants, information on the main outcome

When:
Start data access 3 months after printing results

To whom:
Researchers and students in academic institutions

Conditions:
Use documentation in an article or dissertation

Where to obtain:
By e-mail address

How to obtain:
Apply by e-mail and it will be sent within 15 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, Faraz Building, Shokoofeh St., Imam Square</address>
        <city>Khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813918975</zip>
        <telephone>+98 66 3343 4750</telephone>
        <email>mari01taheri06@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marziyah Asadizaker</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard, School of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3311 5630</telephone>
        <email>Asadizaker-m@ajmus.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having heart failure with class 3, 2 and 4 according to the classification of the New York Heart Association with the diagnosis and confirmation of the relevant doctor.
Patients over 18 years old
Ejection fraction below 45%
Familiarity with Persian language
Full alertness and awareness of time and place
Having a self-care score of 29 to 60 which is moderate to poor self-care (32)
Having a quality of life score higher than 24 which is average and poor quality of life (34</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For patients in the intervention group, 4  face-to-face training sessions of 30 minutes will be conduced for each person every 3 weeks.(The first session, The third week ,The six week and the ninth week will be in the CCU, cardiology department or outpatient cardiology clinics).In the first session, prioritized trainings will be provided for each patient based on the needs assessment obtained from the information of the  questionnaires in the form of face-to-face training and questions and answers. At the end of the first session, patients are emphasized on registering edema in the lower extremities, number of times sitting during the day, recording posture after doing housework, walking, climbing stairs, sleeping position, performing daily activities, recording shortness of breath, anxiety And depression in the notebook and present it to the next session or send via SMS to the researcher. In this case, the patient is encouraged to perform self-monitoring actions and doing these things becomes a daily routine for the patient and his family. In the second, third and fourth sessions, according to the patient's records of his condition, the trainings will be repeated in the areas required by the patient and the patient's possible questions will be answered.</i_keyword>
      <i_keyword>Control group: Patients of the control group will receive routine nursing training after discharge or routine clinic training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score and self-care score of heart failure patients. Timepoint: The beginning of the study and 12 weeks later. Method of measurement: European Heart Failure Self-Care Behavior Questionnaire and Minnesota Quality of Life Questionnaire with Heart Failure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: At the beginning of the study and 12 weeks after the study. Method of measurement: Minnesota Heart Failure Quality of life Questionnaire with 21 questions.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-28</approval_date>
        <contact_name>Ethics Committee of Jundishapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Unit 4, Faraz Building, Shokoofeh St., Imam Square Khoramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
