<?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>IRCT20171219037949N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Two Methods of Education on Adherence to Treatment and Adaptation in Peritoneal Dialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two interventions of promoting illness perception and self-care on adherence to treatment and adjustment to illness in patients undergoing peritoneal dialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28579</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: At first, using the lottery, Imam Reza's center (AS) became the group of perception of the disease and the center of Qa'im (AS) as a self-care group. Then, sampling in each group (30 people) was performed purposefully.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Peritoneal Dialysis.</hc_freetext>
      <i_freetext>Intervention 1: illness perception group: In this group, first, Preception of Illness was evaluated using the BIPQ questionnaire. Then, in 4 sessions of 20 to 30 minutes, the patients received the perception of the disease intervention individually and weekly for two sessions. This intervention was based on five dimensions of perception of the disease. At the first session, the introduction of a researcher and acquaintance with the patient and completion of the questionnaires, in the second session on the nature of the disease and the symptoms and physical and mental symptoms associated with the disease, as well as the expected outcomes and outcomes of the person from the disease in terms of physical, psychological, economic effects And social. At the third session, individual beliefs about the causes of the disease were evaluated and corrected, and the individual's understanding of the duration of the disease was corrected and the effectiveness of control and treatment was emphasized and a fourth assessment of the overall process was carried out. In fact, intervention was designed to change the misconception and negative perception that the patient might have about the disease. Intervention 2: self - care group: In this group, four sessions of 20 to 30 minutes received self-care intervention individually and weekly in two sessions. The educational content included diet and nutrition, dietary restrictions and relative fluid limits, activity levels, dialysis procedures, peritoneal catheter care, and control and evaluation of perinatal conditions and peritoneum. Educational pamphlets and instructional materials and instructional films provided the patient with proper peritoneal dialysis.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasanzadeh Farzaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina St, Doctora Crossroads, Daneshgah Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95199-85845</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>HasanzadehF@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Hasanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Street, Doctora Crossroads, Ibn Sina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95199-85845</zip>
        <telephone>+98 38591511</telephone>
        <email>HasanzadehF@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ESRD diagnosis by a specialist and filed in a medical record
At least three months have passed since the patient's first peritoneal dialysis
Age older than 18 years
Read and write</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having a wide field of illness based on records and medical history
having mental-psychiatric disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>illness perception group: In this group, first, Preception of Illness was evaluated using the BIPQ questionnaire. Then, in 4 sessions of 20 to 30 minutes, the patients received the perception of the disease intervention individually and weekly for two sessions. This intervention was based on five dimensions of perception of the disease. At the first session, the introduction of a researcher and acquaintance with the patient and completion of the questionnaires, in the second session on the nature of the disease and the symptoms and physical and mental symptoms associated with the disease, as well as the expected outcomes and outcomes of the person from the disease in terms of physical, psychological, economic effects And social. At the third session, individual beliefs about the causes of the disease were evaluated and corrected, and the individual's understanding of the duration of the disease was corrected and the effectiveness of control and treatment was emphasized and a fourth assessment of the overall process was carried out. In fact, intervention was designed to change the misconception and negative perception that the patient might have about the disease</i_keyword>
      <i_keyword>self - care group: In this group, four sessions of 20 to 30 minutes received self-care intervention individually and weekly in two sessions. The educational content included diet and nutrition, dietary restrictions and relative fluid limits, activity levels, dialysis procedures, peritoneal catheter care, and control and evaluation of perinatal conditions and peritoneum. Educational pamphlets and instructional materials and instructional films provided the patient with proper peritoneal dialysis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: Start the study, three weeks after the intervention, six weeks after the intervention. Method of measurement: researcher-made questionnaire on Adherence to treatment in peritoneal dialysis patients.</prim_outcome>
      <prim_outcome>Psychosocial adjustment to illness. Timepoint: Start the study, three weeks after the intervention, six weeks after the intervention. Method of measurement: Psychosocial Adaptation to Illness Survey (PAIS).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-21</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Avenue, Doctora Crossroads, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
