<?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>IRCT2016062823779N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-07</date_registration>
      <primary_sponsor>Research Council of Urmia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of care centered group discussion and workshops on the caregiver burden</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of care centered group discussion and workshops on the caregiver burden of patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20259</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Group discussion:&#13;
This program consist of 6 sessions of group discussion (2 hour) during 6 weeks. To facilitate the work, as well as increase  performance classes, their intervention groups will be divided into smaller groups. So that the group discussion divided  into third groups. The topics  of the program include  learning more about end stage renal disease, principle of self care,  personal health, role planning and delegating  tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances. Intervention 2: Workshops:&#13;
 This program consist of 4 sessions of workshops (4 hour) during 4 weeks To facilitate the work, as well as increase  performance classes, their intervention groups will be divided into smaller groups. So that workshop will be divided into 2 groups. The topics  of the program include  learning more about end stage renal disease, principle of self care,  personal health, role planning and delegating  tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances. Intervention 3: Control group:&#13;
 Routine training will be conducted in the control group. After intervention, educational booklet will be given to the control group.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Torabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, University of Medical Sciences, Cero road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>torabi.m@umsu.ac.irmehditorabi90@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masomeh Hemmati Maslak Pak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nazloo College ,  km 11 Cero Road, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>hemmatma@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Include criteria: Age between 18-60 years; Can read and right; Lack of mental illness and chronic physical and cognitive disorders, hearing and vision; Lack of use drugs and psychotropic substances; The care of patients have at least 6 months; Is not a member of the medical team; With the patient in one place to live; Are main caregivers; Orientation to Persian language; Access to cell phone or telephone; Be able to participate in training sessions; Don’t Participate in other educational classes.&#13;
&#13;
Exclude criteria: Don’t  attend two training sessions; Death of the patient in during of this study; Don’t  want to attend classes.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Extracorporeal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group discussion:&#13;
This program consist of 6 sessions of group discussion (2 hour) during 6 weeks. To facilitate the work, as well as increase  performance classes, their intervention groups will be divided into smaller groups. So that the group discussion divided  into third groups. The topics  of the program include  learning more about end stage renal disease, principle of self care,  personal health, role planning and delegating  tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances.</i_keyword>
      <i_keyword>Workshops:&#13;
 This program consist of 4 sessions of workshops (4 hour) during 4 weeks To facilitate the work, as well as increase  performance classes, their intervention groups will be divided into smaller groups. So that workshop will be divided into 2 groups. The topics  of the program include  learning more about end stage renal disease, principle of self care,  personal health, role planning and delegating  tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances.</i_keyword>
      <i_keyword>Control group:&#13;
 Routine training will be conducted in the control group. After intervention, educational booklet will be given to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Burnout severity. Timepoint: before intervention and 1 week after intervention. Method of measurement: Zarit caregiver burden scale.</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>Research Council of Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-09</approval_date>
        <contact_name>Urmia University of Medical Sciences and Health Services</contact_name>
        <contact_address>Emergency district, Resalat Blvd, Urmia Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
