<?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>IRCT2017022514086N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-06</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences, Vice Chancellor of Research &amp; Technology</primary_sponsor>
      <public_title>The effect of empowerment program based on BASNEF model on general health and self-efficacy of hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of empowerment program based on BASNEF model on general health and self-efficacy of hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: For intervention group patient, BASNEF-based empowerment program is performed by researchers. Intervention method so that Patients in groups (least 8 people and maximum 15 people) in 8 sessions 60 minutes (over 4 weeks and two days in a week), in a hemodialysis department in a place separate from hospitalized part of other patients, will participate. During the meeting's the program, about Problems, feelings, opinions and thoughts of patients regarding hemodialysis and their lives, the importance of hemodialysis, recognizing complications and their prevention and treatment, the correct style of life in the fields of nutrition, exercise, self-care, anxiety and stress management, coping with negative attitudes, cognitive restructuring and patient's enabling factors, as group with lecture, group discussion and questions and answers methods will be discussed. According BASNEF model, in addition to the investigator and the patient, a meeting attended by treatment team members (Physicians, nurses and dietitian) and a meeting with a member of the patient family, will be held. In addition, the educational content in the form of a pamphlet available patient Family member will be, so that the education offered continuing more. Intervention 2: Patients in the control group underwent routine cares and educations and them will gave the hemodialysis patients special educational pamphlet.</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>Mohammad Aghajani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Aghajani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>aghajani1362@yahoo.com; aghajani_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
1. Patients treated with chronic hemodialysis according to specialist diagnosis. &#13;
2. Willingness to participate in research. &#13;
3. Aged 18 to 65 years. &#13;
4. A history of well-known mental problems and kidney transplant is not. &#13;
5. Known cognitive problems including Alzheimer's disease, stroke, transient ischemic attack and hearing and vision loss to the extent that they cannot read or write; not suffered. &#13;
6. Physical and mental ability have to participate in empowerment meetings and be able to talk. &#13;
7. The caregiver is an important person for studying person and trust and confidence family and relatives his/her that directly involved in patient care.&#13;
Exclusion criteria: &#13;
1. Dissatisfaction with continuation of cooperation with the study for any reason and at any phase &#13;
2. The absence in two or more sessions in the research program.&#13;
3. Outbreak debilitating complications of the disease.&#13;
4. Studying person died during the study.</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>Behavior</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For intervention group patient, BASNEF-based empowerment program is performed by researchers. Intervention method so that Patients in groups (least 8 people and maximum 15 people) in 8 sessions 60 minutes (over 4 weeks and two days in a week), in a hemodialysis department in a place separate from hospitalized part of other patients, will participate. During the meeting's the program, about Problems, feelings, opinions and thoughts of patients regarding hemodialysis and their lives, the importance of hemodialysis, recognizing complications and their prevention and treatment, the correct style of life in the fields of nutrition, exercise, self-care, anxiety and stress management, coping with negative attitudes, cognitive restructuring and patient's enabling factors, as group with lecture, group discussion and questions and answers methods will be discussed. According BASNEF model, in addition to the investigator and the patient, a meeting attended by treatment team members (Physicians, nurses and dietitian) and a meeting with a member of the patient family, will be held. In addition, the educational content in the form of a pamphlet available patient Family member will be, so that the education offered continuing more.</i_keyword>
      <i_keyword>Patients in the control group underwent routine cares and educations and them will gave the hemodialysis patients special educational pamphlet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>General health. Timepoint: At baseline and a week after the last session implantation in the intervention group and after a month of the start of the study in the control group. Method of measurement: Goldberg's General Health Questionnaire‏.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: At baseline and a week after the last session implantation in the intervention group and after a month of the start of the study in the control group. Method of measurement: Sherer's General Self-Efficacy 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>Kashan University of Medical Sciences, Vice Chancellor of Research &amp; Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-28</approval_date>
        <contact_name>Kashan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research &amp; Technology, Kashan University of Medical Sciences, 5th km of Ravandi Ghotb Blvd, Kashan Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
