<?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>IRCT20171105037236N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-06</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Training through telenursing for hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of telenursing on self-care, readmission and psychological reactions of  hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35918</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 80 individuals will be randomly assigned to two groups. Block randomization based on permutation. Accordingly, 20 blocks will be allocated to patients, in each block 2 from study group and 2 from the control group will be placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Telephone follow up telenursing training.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in this group, the telephone training will be conducted by the researcher for 12 weeks (3 months). The telephone training will be conducted twice a week, and the duration of the telephone training will be 15 minutes per training on average. Patients will be trained in telephone conversations with diet, fluid intake, fistula care, skin care, exercise and rest, treatment follow-up, infection prevention, digestive problems, anxiety, stress and self-care education. Before and after the study, patients with self-care and DASS21 questionnaires will be examined. Intervention 2: Control group: In the control group, routine care has been taken and there is no intervention. Before and after the study, patients with self-care and DASS21 questionnaires will be examined.</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:
The Main Outcomes of the Participants are Public.

When:
6 months after the results .

To whom:
Researchers at Academic and Academic Institutions .

Conditions:
Statistical Result .

Where to obtain:
Nursing and Midwifery Faculty of Zahedan Phone and Fax: 05433442481 Zip Code: 9816913396 Address: Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square

How to obtain:
En Contact the Nursing Faculty Library section.

Comments:
Does not have</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasan Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square</address>
        <city>Zahdan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3344 2481</telephone>
        <email>Askarihass77@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3344 2481</telephone>
        <email>Askarihass77@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Beginning hemodialysis in the past year
Having a history of at least one hospitalization due to hemodialysis complications during the past three months
Having a cell phone to call Telenursing
Having ages 18 to 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having at least reading and writing literacy
Inability to establish verbal communication
Presence of psychological disorders and treatment with antidepressants in the last 3 months
Reject to enter the study or non-cooperation at each stage of the research
Failure to respond to cell phone for 2 weeks in the first month and for 3 weeks in the second month
Immigration or travel for more than 3 months
The occurrence of new stressors (psychological and disease)
Kidney transplant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for fitting and adjustment of extracorporeal dialysis catheter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in this group, the telephone training will be conducted by the researcher for 12 weeks (3 months). The telephone training will be conducted twice a week, and the duration of the telephone training will be 15 minutes per training on average. Patients will be trained in telephone conversations with diet, fluid intake, fistula care, skin care, exercise and rest, treatment follow-up, infection prevention, digestive problems, anxiety, stress and self-care education. Before and after the study, patients with self-care and DASS21 questionnaires will be examined</i_keyword>
      <i_keyword>Control group: In the control group, routine care has been taken and there is no intervention. Before and after the study, patients with self-care and DASS21 questionnaires will be examined</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self care: The score will be accounted of hemodialysis patients self care scale by participant and its scope is 0-72. Timepoint: Self-care measurements before and 12 weeks after study. Method of measurement: Self care questionnaire.</prim_outcome>
      <prim_outcome>Readmission: Reception of patients until 30 days after discharge. Timepoint: Measurement of re-admission before and 12 weeks after the study. Method of measurement: the number of readmission using hospital HIS system.</prim_outcome>
      <prim_outcome>Stress:The score of stress in DASS21 questionnaire. Timepoint: Measurement of stress score before and 12 weeks after the study. Method of measurement: ِDASS21 questionnaire.</prim_outcome>
      <prim_outcome>Depression: The score of depression in DASS21 questionnaire. Timepoint: Measurement of depression score before and 12 weeks after the study. Method of measurement: ِDASS21 questionnaire.</prim_outcome>
      <prim_outcome>Anxiety: Anxiety Score in the DASS21 questionnaire. Timepoint: Measurement of anxiety score before and 12 weeks after the study. Method of measurement: ِDASS21 questionnaire.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-08</approval_date>
        <contact_name>Ethics Committee of Zahadan University of Medical Sciences</contact_name>
        <contact_address>School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
