<?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>IRCT20201018049059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-31</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-management promotion model on quality of life and self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-management promotion model on quality of life and self-efficacy of patients with chronic heart failure.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55339</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done by permuted block randomization method. First, 6 blocks of 4 consisting of two letters A and B will be prepared and we will assign a number from 1 to 6 to each of them. Then, using the random number table, the numbers 1 to 6 are selected (15 numbers). Finally, a sequence of 60 letters A and B will be obtained. Each sample will have a number from 1 to 60 if they include the present study, and each person will receive an A or B code based on the number in the list. Also, blinding will not be done due to face-to-face training.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Heart Failure Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The self-management promotion model will be implemented in the intervention group. This model includes steps 1) case selection, 2) identifying patients' problems, 3) formulating a care plan, 4) implementing the intervention, 5) evaluation and 6) continuous monitoring of the patient's condition. The intervention will be held in eight sessions (two sessions per week, each session for 20 minutes in one month). Data will be collected using a three-part questionnaire including demographic characteristics, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and Sullivan Cardiac Self-Efficacy Questionnaire at three time periods (before, immediately, and one month after the intervention). Educational content will be provided to participants using pamphlets, booklets, and educational videos. Intervention 2: Control group: Eligible participants in the control group will receive conventional care. conventional care includes in-hospital and discharges training according to Brunner &amp; Suddarth's Medical-Surgical Nursing 14th Ed (2018) in relation to disease-related care such as diet, nutrition, fluid intake, possible complications of the disease. In the present study, these trainings are provided by the researcher. Patients will complete the questionnaires in person before providing routine care. The researcher will also follow up on participants' quality of life and self-efficacy in the eighth week by asking questions via telephone.</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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
Access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
Researchers in the field of hemodialysis on request

Where to obtain:
Contact the authors of the present study via email of the corresponding author.
Email: Javad.ghazanfari12@gmail.com.

How to obtain:
Contact the authors of the present study via email of the corresponding author.
Email: Javad.ghazanfari12@gmail.com.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Javad Ghazanfari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Province, Kashan, Qutb Ravandi Blvd, hekmat 56, Kashan University of Medical Sciences and Health Services</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159-73474</zip>
        <telephone>+98 11 3320 7545</telephone>
        <email>Javad.ghazanfari12@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Javad Ghazanfari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Province, Kashan, Qutb Ravandi Blvd, hekmat 56, Kashan University of Medical Sciences and Health Services</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159-73474</zip>
        <telephone>+98 11 3320 7545</telephone>
        <email>Javad.ghazanfari12@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the present study
Age 18 to 65 years
A definitive diagnosis of heart failure at discharge (Class 2 (EF=30% to 45%) and 3 (EF &lt;30%) Heart failure)
Classes 2 and 3 based on the New York Heart Failure Criterion
Having a medical sphygmomanometer and scales
Ability to call and follow up</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with underlying diseases such as chronic renal failure, liver cirrhosis in the past month, and cancer.
Have mental illness.
Inability to self-care.
Participate in another study at the same time.</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>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The self-management promotion model will be implemented in the intervention group. This model includes steps 1) case selection, 2) identifying patients' problems, 3) formulating a care plan, 4) implementing the intervention, 5) evaluation and 6) continuous monitoring of the patient's condition. The intervention will be held in eight sessions (two sessions per week, each session for 20 minutes in one month). Data will be collected using a three-part questionnaire including demographic characteristics, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and Sullivan Cardiac Self-Efficacy Questionnaire at three time periods (before, immediately, and one month after the intervention). Educational content will be provided to participants using pamphlets, booklets, and educational videos.</i_keyword>
      <i_keyword>Control group: Eligible participants in the control group will receive conventional care. conventional care includes in-hospital and discharges training according to Brunner &amp; Suddarth's Medical-Surgical Nursing 14th Ed (2018) in relation to disease-related care such as diet, nutrition, fluid intake, possible complications of the disease. In the present study, these trainings are provided by the researcher. Patients will complete the questionnaires in person before providing routine care. The researcher will also follow up on participants' quality of life and self-efficacy in the eighth week by asking questions via telephone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: In three time periods (before, immediately, and one month after the intervention). Method of measurement: Minnesota Living with Heart Failure Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: In three time periods (before, immediately, and one month after the intervention). Method of measurement: Sullivan Cardiac Self-Efficacy Questionnaire.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-11</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Isfahan, Kashan, Ghotb Ravandi Blvd., Hekmat 56, Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
