<?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>IRCT20171212037847N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-30</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of peer education on depression, anxiety, stress،quality of life and adherence  among patients receiving dialysis</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of peer education on depression, anxiety, stress،quality of life and adherence  among patients receiving dialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2639-09-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/28907</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients receive dialysis either in odd or even days of the week,select in this study. In order to prevent the leakage of peer education information from the intervention group to the control group, patients who receive dialysis in even days  randomly allocate  to the intervention group, while patients who receive dialysis in the odd days randomly allocate  to the control group. Random allocation do via the coin tossing method by a nurse who is external to the study. 
Sampling do randomly in the following steps. Initially, the name of each patient who receive dialysis in even days  write on a card. Then, all cards  mix  and place  in a bag. After that, one card  randomly draw from the bag and the intended patient  recruit  to the intervention group. The card  then return to the bag and a new card  select  for the next patient. The same process repeat until the determined number of patients  recruit. Patients for the control group  also recruit  through the same process. Due to the characteristics of the study intervention, blinding and allocation concealment not applicable for this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic kidney disease, stage 5.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: peer education. Intervention 2: Control group: routine care services.</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:
Researcher that work in academic and scientific institutes can access to demographic variable and main outcome such as depression, anxiety,stress, adherence, quality of life of this study.

When:
Academic and scientific researcher access to data, 6 months after publication result.

To whom:
Researcher that work in academic and scientific institutes can access to  data.

Conditions:
you can analyse data with SPSS but you do not access to confidential patient data.

Where to obtain:
if you need to access to data,you can call  with me or send email for me.
Call number:00989134118910
Email: maryamhashemi956@gmail.con

How to obtain:
After I receive your request,I send them after 10 -30 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Sadat Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No: 20, Memarzade Alley, Sepenta Avenue, Isfahan, Iran.zip Code: 81999-47741.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199875784</zip>
        <telephone>+98 31 3225 3349</telephone>
        <email>Maryamhashemi956@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Sadat Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No: 20, Memarzade Alley, Sepenta Avenue, Isfahan, Iran.zip Code: 81999-47741.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8199875784</zip>
        <telephone>+98 31 3225 3349</telephone>
        <email>Maryam.hashemi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients have definite diagnosis of renal failure,
a history of receiving dialysis for more than three months
no history of cognitive problems such as memory impairment
no simultaneous participation in peer education programs</inclusion_criteria>
      <agemin>1999 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recruited patients  exclude if they voluntarily voluntarily chose to withdraw from the study
patients  exclude if they incompletely filled out study questionnaire
patients  exclude if they  hospitalize in hospital
patients  exclude if they underwent kidney transplant surgery during the study.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: peer education</i_keyword>
      <i_keyword>Control group: routine care services</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Patients’ depression  assess before and immediately and 1 month  after the intervention via the 42-item Depression Anxiety Stress Scale (DASS-42). Method of measurement: Patients’ depression  assess  via the   depression Anxiety Stress Scale -42 Item(DASS- 42).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Patients’ anxiety  assess before and immediately and 1 month  after the intervention via the 42-item Depression Anxiety Stress Scale (DASS-42). Method of measurement: Patients’ anxiety   assess  via the   depression Anxiety Stress Scale -42 Item(DASS- 42).</prim_outcome>
      <prim_outcome>Stress. Timepoint: Patients’ stress assess before and immediately and 1 month  after the intervention via the 42-item Depression Anxiety Stress Scale (DASS-42). Method of measurement: Patients’ stress assess via the depression Anxiety Stress Scale -42 Item(DASS- 42).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Patients’ quality of life  assess before and immediately  after the intervention via the Kidney Disease Quality of Life–Short Form version 1.3 (KDQOL-SF ver. 1.3). Method of measurement: Patients’ quality of life assess via the Kidney Disease Quality of Life–Short Form version 1.3 (KDQOL-SF ver. 1.3).</prim_outcome>
      <prim_outcome>Adherence. Timepoint: Patients’ adherence assess before and immediately  after the intervention via the end-Stage Renal Disease Adherence Questionnaire (ESRDAQ). Method of measurement: Patients’ adherence assess via the end-Stage Renal Disease Adherence Questionnaire (ESRDAQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Isfahan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
      <source_name>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-17</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Noor and Hazrat-e-Ali Asghar Hospital,Hasht Behesht Ave., Ostandari St., Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
