<?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>IRCT138809032769N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-30</date_registration>
      <primary_sponsor>Research Assistance of Iran University of Medical Sciences</primary_sponsor>
      <public_title>Supportive Educative Program on Caregiver’s in Hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Supportive Educative Program on Caregiver’s Burden and Quality of life in Hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2607</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Caregivers in this study randomly will be placed in intervention and control groups Based on reference days, for the patient’s hemodialysis in one and couple.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis - Chronic kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: In this study, the intervention program consisted of 6 sessions training on how to care hemodialysis patient and problem-oriented coping skills (Communicating correctly, anger management, deep breathing) for adapting to the role of caregivers that will be divided into two separate parts and intervention program will be starts follows; first the learning part of how to care patients with hemodialysis at home will be trained during first two session and then the training part of problem-oriented skills will be conducted during four next sessions, Each session will be one hour during two weeks with lecture, role playing, group discussion, Questions and answers by using slide and training booklet. The prepared training booklet in first session of training program will be given to the caregivers and it will be emphasized to study the issues of each session at home. During sessions, the researcher will encourage the caregivers to Q and A and  group discussion about the questions and ambiguities. At the end of each session, the conclusion will be summarized by participants. Also, The Caregivers will be asked to exercise and repeat these skills at home. And during sessions, they should exercise the anger management  and deep breathing skills as role playing in class. Also The Telephone number of researcher will be given to caregivers for solving the problems and  answer to questions. &#13;
In the first session, the researcher after its introduction, divides the caregivers into 5-8 people groups and then will be express the training program, the aim of the intervention and the importance of cooperation, Also the comments about end stage renal disease, its signs and symptoms, causes and treatments and the importance of hemodialysis will be given to patients. In the second session, care training at home about how to conduct and control the special activities such as patient transmission, providing personalized patient care (bathing, hygiene, clothing, physical activity, diet and medication, weight control and blood pressure and fistulas treatment) and adjusting the hemodialysis session and monitoring the patient’s condition will be explained. Also, the problems and experiences of caregivers will be examined by group discussion. In third session, the importance of caregiver role and his/her adjustment with this role will be discussed and we will discuss about the compatibility problems conducted for caregivers. And in fourth session, issues about problem-oriented coping skills to properly communicate will be presented. And in the fifth and sixth sessions, will discussed about the warning signs of anger, the creator and resonator situation, how to control anger. Intervention 2: For control group, the training will not give by researcher and routine approaches of educational Hashemi Nejad Medical Centers will be given to them that include educational pamphlets.</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>Mansoore Ashghali Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran School of Nursing and Midwifery , Yasami  St., Vali asr Avenue.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997613883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>m_negar@yahoo.com ؛ Farahani.ma@iums.ac.ir</email>
        <affiliation>Iran School of Nursing and Midwifery, Iran Universityof Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansooreh Ashghali Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran School of Nursing and Midwifery , Yasami  St., Vali asr Avenue .</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997613883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>m_negar@yahoo.com ؛  Farahani.ma@iums.ac.ir</email>
        <affiliation>Iran School of Nursing and Midwifery, Iran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for patients: &#13;
1- Age 18 to 65 years old with hemodialysis program per week (three times per week and each time, 3-4 hours).&#13;
 2- Have a primary caregiver at home.&#13;
 3- No previous history of renal transplant.&#13;
Inclusion criteria for caregivers:&#13;
 1- caregivers should have the primary responsibility to care of the patient and should be a member of family.&#13;
 2- Age more than 18 years old.&#13;
3- Have the ability to speak, read and write in farsi. &#13;
4- Do not any known mental or neurological disorder.&#13;
 5-Caregivers should not be a member of medical staff.&#13;
 The exclusion criteria:&#13;
1-Occurrence of stressful events in family ( divorce, financial crisis, death of the primary family members).&#13;
 2-Participating in training courses related with research intervention program during the study. &#13;
3- The lack of willingness to continue participating  during the study.&#13;
 4-The absence of primary caregiver who receipts training even in one training session.&#13;
 5-The patient should be a candidate for kidney transplant during the study.&#13;
 6-Protecting other chronic patients except hemodialysis patient in the family.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, the intervention program consisted of 6 sessions training on how to care hemodialysis patient and problem-oriented coping skills (Communicating correctly, anger management, deep breathing) for adapting to the role of caregivers that will be divided into two separate parts and intervention program will be starts follows; first the learning part of how to care patients with hemodialysis at home will be trained during first two session and then the training part of problem-oriented skills will be conducted during four next sessions, Each session will be one hour during two weeks with lecture, role playing, group discussion, Questions and answers by using slide and training booklet. The prepared training booklet in first session of training program will be given to the caregivers and it will be emphasized to study the issues of each session at home. During sessions, the researcher will encourage the caregivers to Q and A and  group discussion about the questions and ambiguities. At the end of each session, the conclusion will be summarized by participants. Also, The Caregivers will be asked to exercise and repeat these skills at home. And during sessions, they should exercise the anger management  and deep breathing skills as role playing in class. Also The Telephone number of researcher will be given to caregivers for solving the problems and  answer to questions. &#13;
In the first session, the researcher after its introduction, divides the caregivers into 5-8 people groups and then will be express the training program, the aim of the intervention and the importance of cooperation, Also the comments about end stage renal disease, its signs and symptoms, causes and treatments and the importance of hemodialysis will be given to patients. In the second session, care training at home about how to conduct and control the special activities such as patient transmission, providing personalized patient care (bathing, hygiene, clothing, physical activity, diet and medication, weight control and blood pressure and fistulas treatment) and adjusting the hemodialysis session and monitoring the patient’s condition will be explained. Also, the problems and experiences of caregivers will be examined by group discussion. In third session, the importance of caregiver role and his/her adjustment with this role will be discussed and we will discuss about the compatibility problems conducted for caregivers. And in fourth session, issues about problem-oriented coping skills to properly communicate will be presented. And in the fifth and sixth sessions, will discussed about the warning signs of anger, the creator and resonator situation, how to control anger.</i_keyword>
      <i_keyword>For control group, the training will not give by researcher and routine approaches of educational Hashemi Nejad Medical Centers will be given to them that include educational pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver’s Burden. Timepoint: Pre test  and Six Week’s after intervention. Method of measurement: Caregiver’s Burden index.</prim_outcome>
      <prim_outcome>Caregiver’s Quality of life. Timepoint: Pre test  and Six Week’s after intervention. Method of measurement: Quality of life sf-36.</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 Assistance of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-11</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Between The Highway Martyr Chamran  and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway ,Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
