<?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>IRCT20180615040106N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>"The Effect Of Nutrition Education In Ileostomy Patients With Smartphone"</public_title>
      <acronym></acronym>
      <scientific_title>Study Of The Effect Of Smartphone-based Nutrition Education On Biochemistry And Anthropometric Indices Of Ileostomy Subjects</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32844</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People With Ileostomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Smartphone Training Is Based On Two Sessions Of Instruction For The Installation And Use Of The App, Which Includes Nutrition And Diet, After The Surgery, Before The Patient Is Discharged. The First Session Will Include Introducing The App And Installing A Training Program On The Patient's Or His Family's Smartphone, And In The Second Session You Will Learn How To Use The App And Answer Questions Related To The App. Anthropometric Analyzes (Including Measurements Of Body Mass Index, Median Arm Circumference, Skin Thickness In The Trunk Head And Waist Profile) And Biochemical (Including: Hemoglobin, Albumin, Transferrin, Reactive Protein C, Number Of Lymphocytes) In Order To See The Result Of Training In Nutritional Indices In Patients With Ileostomy, It Is Done In Two Steps. The First Stage, The Day Before The Surgery, Is Considered In The Pre-Intervention Phase, And The Second Stage Is Three Weeks After The Surgery And The Insertion Of The Ileostomy. Intervention 2: Control Group: Applying Appropriate Nutrition and Nutrition Training is Done by The Relevant Department Staff, Based on The Routine Section That Includes The Presentation of Pamphlets and Face-to-Face Training. Anthropometric Examinations (Including Measurements of Body Mass Index, Midarm Circumference,  Tricuspid Skin Fold Thickness and Waist Circumference) and Biochemical (Including: Hemoglobin, Albumin, Transferrin, Reactive Protein C, Number of lymphocytes), To See The Result of Training in Nutritional Indices in Patients With Ileostomy, in Two Stages Gets The First Stage, The Day Before The Surgery, is Considered in The Pre-intervention Phase, and The Second Stage is Three Weeks After The Surgery and The Insertion of The Ileostomy.</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:
Total Non-identifiable Data, The Potentialof The People Sharing

When:
Start Access 2018/8

To whom:
Professors and Students

Conditions:
-

Where to obtain:
-akhondian.gh@tak.iums.ac.ir

How to obtain:
Request Via E-mail and Respond by E-mail Within one Week to DO.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghazaleh Akhoondian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>akhondian.gh@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghazaleh Akhoondian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۶۷۱۳۸۸۳</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>akhondian.gh@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not Having A Particular Diet Related To Underlying Disease, Including Diabetics, Low Salt And Low Fat, And ...
Owning A Smartphone With Android OS
Have At Least Reading And Writing Skills.
Ability To Work With Smartphone.
Mighty To Communicate.
Starting Oral Nutrition Before 7 Days After Surgery.
Lack Of Known Psychological Diseases.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwilling To Participate In The Study.
Lack Of Cooperation In The Study.
Not Attending A Training Session.
Readmission (Due to: Non-nutritional Items, Including: Wound Infection, Stomach Hernia, etc.)
Longer Hospitalization Time Due to Problems Caused During Surgery.
Starting Chemotherapy Before The Third Week After The Implantation of Postoperative Ileostomy In Patients.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for attention to ileostomy</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: Smartphone Training Is Based On Two Sessions Of Instruction For The Installation And Use Of The App, Which Includes Nutrition And Diet, After The Surgery, Before The Patient Is Discharged. The First Session Will Include Introducing The App And Installing A Training Program On The Patient's Or His Family's Smartphone, And In The Second Session You Will Learn How To Use The App And Answer Questions Related To The App. Anthropometric Analyzes (Including Measurements Of Body Mass Index, Median Arm Circumference, Skin Thickness In The Trunk Head And Waist Profile) And Biochemical (Including: Hemoglobin, Albumin, Transferrin, Reactive Protein C, Number Of Lymphocytes) In Order To See The Result Of Training In Nutritional Indices In Patients With Ileostomy, It Is Done In Two Steps. The First Stage, The Day Before The Surgery, Is Considered In The Pre-Intervention Phase, And The Second Stage Is Three Weeks After The Surgery And The Insertion Of The Ileostomy.</i_keyword>
      <i_keyword>Control Group: Applying Appropriate Nutrition and Nutrition Training is Done by The Relevant Department Staff, Based on The Routine Section That Includes The Presentation of Pamphlets and Face-to-Face Training. Anthropometric Examinations (Including Measurements of Body Mass Index, Midarm Circumference,  Tricuspid Skin Fold Thickness and Waist Circumference) and Biochemical (Including: Hemoglobin, Albumin, Transferrin, Reactive Protein C, Number of lymphocytes), To See The Result of Training in Nutritional Indices in Patients With Ileostomy, in Two Stages Gets The First Stage, The Day Before The Surgery, is Considered in The Pre-intervention Phase, and The Second Stage is Three Weeks After The Surgery and The Insertion of The Ileostomy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number Of Lymphocytes. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Complete Blood Count Test Kit.</prim_outcome>
      <prim_outcome>Hemoglobin Index. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Complete Blood Count Test Kit.</prim_outcome>
      <prim_outcome>Albumin Index. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Albumin Assay Kit.</prim_outcome>
      <prim_outcome>Transferring Index. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Transferrin Assay Kit.</prim_outcome>
      <prim_outcome>C Reactive Protein. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: C Reactive Protein Elisa Kit.</prim_outcome>
      <prim_outcome>Body Mass Index. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Calculation Of Height Based On Meter And Weight In Kilograms And Placing In The Formula Of Division Of Weight Into Squared Height.</prim_outcome>
      <prim_outcome>Midarm circumference. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Measure with Cloth Meter.</prim_outcome>
      <prim_outcome>Tricuspid skin fold thickness. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Measure With Caliper.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: This Is Done In Two Steps: The First Stage, The Day Before The Surgery, Which Was Considered In The Pre-intervention Stage, And The Second Stage, Three Weeks After The Surgery And The Insertion Of The Ileostomy. Method of measurement: Measure With Cloth Meter.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-26</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
