<?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>IRCT20190917044802N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-31</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education on quality of life, adherence to treatment and self-care of hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-care education based on Orem theory on quality of life, adherence to treatment and self-care of hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60876</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: The present study is a double-blind randomized clinical trial intervention that will be performed on 80 patients with end-stage renal disease undergoing hemodialysis who are divided into two groups of intervention and control. To determine the sample size, the average comparison formula in the two dependent groups will be used. In the study of the effect of applying the Orem self-care model on the quality of life of patients undergoing hemodialysis, conducted by Soleiman Naroui et al., 35 patients were selected as the sample size. The minimum sample size in each group in this study was 16 people. Due to the possibility of falling samples in the present study, 40 people will be selected in each groupOrem self-care model training through 4 groups of 20 people, which will be held virtually by WhatsApp and phone message due to coronary conditions. Classes will be held for 1 hour in the form of group discussions and lectures with educational pamphlets (due to coronary conditions and the need to prevent and control infection, especially in patients with end-stage renal disease, we tried to use educational booklets, educational pamphlets and telephone calls). After stating the objectives of the study for patients obtaining informed written consent during the first session of chronic renal failure, its cause, exacerbating factors, complications of the disease, its effects on life, exacerbating factors and improving and reducing factors in the second session with In the third session, the importance of participation in communities, weight care, sexual activity, exercise, self-care activities, and in the fourth session, the importance of adhering to the schedule, refer to The doctor will be instructed to refer to dialysis and follow the treatment. Educational pamphlets will also be provided to them. The scientific content of the training program will be designed and approved by 10 nursing professors and 5 kidney specialists. No educational intervention will be performed for patients in the control group and only pamphlets and educational content will be given to them. Before the training, immediately after the training and three months after the training in the control and intervention group, the questionnaire of quality of life, self-care and adherence to treatment will be completed, Randomization description: Sampling is a simple random assignment, such as in an 80-card envelope with the letter A written on 40 cards and the letter B on the other 40 cards. Patients who meet the inclusion criteria are asked to pick up a card. If they pick up card A, they will be in the test group and if they pick up card B, they will be in the control group and this process will continue until the sample size is completed, Blinding description: The present study is a double-blind study in which both participants and researchers or outcome assessors are unaware of the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diseases of the urinary system.</hc_freetext>
      <i_freetext>Intervention group: Orem self-care model training through 4 groups of 20 people, which will be held virtually by WhatsApp and phone message due to coronary conditions. Classes will be held for 1 hour in the form of group discussions and lectures with educational pamphlets (due to coronary conditions and the need to prevent and control infection, especially in patients with end-stage renal disease, we tried to use educational booklets, educational pamphlets and telephone calls). After stating the objectives of the study for patients obtaining informed written consent during the first session of chronic renal failure, its cause, exacerbating factors, complications of the disease, its effects on life, exacerbating factors and improving and reducing factors in the second session with In the third session, the importance of participation in communities, weight care, sexual activity, exercise, self-care activities, and in the fourth session, the importance of adhering to the schedule, refer to The doctor will be instructed to refer to dialysis and follow the treatment. Educational pamphlets will also be provided to them. The scientific content of the training program will be designed and approved by 10 nursing professors and 5 kidney specialists..</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:
All data is potentially shareable after unidentified individuals

When:
Until the end of 1401

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Access to the data and documentation will be provided upon request and approval of the research team members

Where to obtain:
The main executor of the project is Dr. Mostafa Bijani. Fasa Medical Sciences

How to obtain:
Receive a request to use the documentation and submit the documentation within 2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mostafa Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Street. Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>02153350994-6</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mostafa Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Street. Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>02153350994-6</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include: age 15 to 70 years, not attending training class during the last 3 months, no mental health problem, having primary education, no chronic disease such as liver cirrhosis, end-stage cancer, ability to consciously satisfy exit conditions : Death of the patient, incompleteness of the questionnaire, kidney transplantation</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria include: death of the patient, incompleteness of the questionnaire, kidney transplantation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>GC2Z</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the urinary system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Orem self-care model training through 4 groups of 20 people, which will be held virtually by WhatsApp and phone message due to coronary conditions. Classes will be held for 1 hour in the form of group discussions and lectures with educational pamphlets (due to coronary conditions and the need to prevent and control infection, especially in patients with end-stage renal disease, we tried to use educational booklets, educational pamphlets and telephone calls). After stating the objectives of the study for patients obtaining informed written consent during the first session of chronic renal failure, its cause, exacerbating factors, complications of the disease, its effects on life, exacerbating factors and improving and reducing factors in the second session with In the third session, the importance of participation in communities, weight care, sexual activity, exercise, self-care activities, and in the fourth session, the importance of adhering to the schedule, refer to The doctor will be instructed to refer to dialysis and follow the treatment. Educational pamphlets will also be provided to them. The scientific content of the training program will be designed and approved by 10 nursing professors and 5 kidney specialists.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: Before, immediately and three months. Method of measurement: Treatment Adherence Questionnaire.</prim_outcome>
      <prim_outcome>Self-care behaviors. Timepoint: Before, immediately and three months. Method of measurement: Self-care behavior questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before, immediately and three months. Method of measurement: Quality of life questionnaire for kidney patients.</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>Vice Chancellor for Research, Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-21</approval_date>
        <contact_name>Ethics Committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Street. Fasa University of Medical Sciences Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
