<?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>IRCT2016020217059N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Urmia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family-centered empowerment model on quality of life in renal transplant patients</public_title>
      <acronym>not used</acronym>
      <scientific_title>Study The effect of family-centered empowerment model on quality of life in renal transplant patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15795</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, specific questionnaire kidney transplant patients (KTQ-25) was used to measure quality of life.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Kidney transplant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: of family-centered empowerment model in four steps (perceived threat, problem solving, educational partnership and evaluation) will be used. The first step is the perceived threat and included 3-4 meeting educational debates. The first meeting topics about the physiology of the kidney, renal failure, symptoms, treatment, and the second meeting about kidney transplant, kidney transplant rejection causes, symptoms and complications of kidney transplant rejected will be. The third meeting about Care of after kidney transplant , including diet, drug use , drug side effects and preventing of possible infections will be. The second step or problem-solving within three meeting, about how to problem-solving with project scenario and group discussions and answer the questions active member patient will be. The third step or educational partnership within two training sessions 30 to 40-minute will be done using educational cards. the final step evaluation process will be done in two phases. The evaluation process will be in the form of questions and answers at the next meeting and final evaluation two months after the intervention by questionnaire KTQ25 will be. Intervention 2: The control group will receive routine clinical care.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Hemmati Maslakpak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orjhans Street, Resalat Blvd, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3365 9031</telephone>
        <email>hemmatma@yahoo.com</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: minimum age of 18 years and a maximum of 60 years, Having at least to read and write literacy, awareness to time and place, the ability to participate in meetings  of the empowerment and completed the questionnaires, lack of mental disorder, Passing the minimum three months after kidney transplant,not having server infection or disability disease , possible establish telephone contact with the patient,have the file at the transplant clinic of Urmia , not used of  the other classes and educational programs in the field of kidney transplant during the study. Family member active inclusion criteria included  Completed consent form participate in the study, the minimum age of 18 years and maximum 60 years, Having at least to read and write literacy, awareness to time and place, , the ability to participate in meetings  of the empowerment and accompany the patient, The ability to Completed questionnaire, lack of mental disorder, the possibility to establish telephone contact with family members active, selected by the patient, the patient obey him, living  with patient, one member of the family (father, mother, sister, brother, partner) who lives with the patient or the patient has quick and easy access,not using other educational classes during the the study, family member active should be able to power and decision-making and the importance of understanding the patient's condition more powerful than others. Exclusion criteria: Exclusion criteria patient and family member active including failure to the completed consent form to participate in the study, lack of comply with the anticipated therapeutic intervention programs and empowerment sessions, the absence of a maximum of two sessions, the rejection of kidney transplants during the study, the use of other classes and educational programs about kidney transplant and postoperative care by patient and active member of the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z94.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney transplant status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: of family-centered empowerment model in four steps (perceived threat, problem solving, educational partnership and evaluation) will be used. The first step is the perceived threat and included 3-4 meeting educational debates. The first meeting topics about the physiology of the kidney, renal failure, symptoms, treatment, and the second meeting about kidney transplant, kidney transplant rejection causes, symptoms and complications of kidney transplant rejected will be. The third meeting about Care of after kidney transplant , including diet, drug use , drug side effects and preventing of possible infections will be. The second step or problem-solving within three meeting, about how to problem-solving with project scenario and group discussions and answer the questions active member patient will be. The third step or educational partnership within two training sessions 30 to 40-minute will be done using educational cards. the final step evaluation process will be done in two phases. The evaluation process will be in the form of questions and answers at the next meeting and final evaluation two months after the intervention by questionnaire KTQ25 will be.</i_keyword>
      <i_keyword>The control group will receive routine clinical care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention quality of life for kidney transplant   patients    will be measure then have three or four months after the intervention. Method of measurement: According to the questionnaires KTQ 25.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Increased life expectancy. Timepoint: before intervention and three months after intervention. Method of measurement: before intervention and three months after intervention and questionnaire KTQ 25.</sec_outcome>
      <sec_outcome>Not rejection of the transplanted kidney. Timepoint: before intervention and three months after intervention. Method of measurement: before intervention and three months after intervention and questionnaire KTQ 25.</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>Vice chancellor for research, Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-11</approval_date>
        <contact_name>Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia - km 11 Sero Road/ Nazlo Pardis Building School of Nursing and Midwifery urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
