<?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>IRCT20230531058349N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-14</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Telenursing Training on Adherence to Treatment Regimen in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Telenursing Training on Adherence to Treatment Regimen in Hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70453</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done by simple and purposeful method according to the inclusion and exclusion criteria.  Then, they will be randomly assigned to intervention and control groups by permutation block method. Six possible cases (BABA, ABBA, BAAB, AABB ABAB, BBAA) will be listed, and by throwing dice of block numbers randomly up to the number of samples will be selected and the subjects will be divided into two groups of intervention (A) and control (B), Blinding description: In this study, participants and their families are fully aware of the study and its complications and benefits and after obtaining informed consent, they are kept blind to random allocation in the experimental and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Adherence to Treatment Regimen in Hemodialysis Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this stage, training will be given to the research units via mobile phone line twice a week for 3 months and each time for 20 minutes. The content of the conversations includes self-introduction, questions about the patient's general health status, encouraging the patient to follow the recommendations and aspects of general and dedicated self-care, follow-up of educational needs that will be based on the patient's educational needs checklist, and the patient will be provided with the necessary training and recommendations and answers to patients' questions.Phone calls and their content for each participant are recorded in certain sheets and at the end of the phone call with the patient's agreement the time of the next call is determined. The recorded file of the call will be sent to the patient by iGap or Soroush. Also, a text containing educational outline will be sent to the patient once a week. Intervention 2: Control group: Lack of follow-up and telephone training.</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:
Information about adherence to the treatment regimen of participants after undetectable

When:
Beginning of access period 3 months after printing

To whom:
Students and Professors of Medical Sciences

Conditions:
After obtaining permission from the investigator

Where to obtain:
moslehiali93@gmail.com

How to obtain:
One week after receiving the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadegh Moslehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 15 Imam Khomeini St.</address>
        <city>Kashmar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9671668618</zip>
        <telephone>+98 51 5524 0793</telephone>
        <email>moslehiali93@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadegh Moslehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 15 Imam Khomeini St.</address>
        <city>Kashmar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9671668618</zip>
        <telephone>+98 51 5524 0793</telephone>
        <email>moslehiali93@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of ESRD by a Specialist Physician and Recorded in the Relevant File
Fill out a Consent Form
At least 3 Months after the First round of Hemodialysis
Hemodialysis twice a week or more and each session 3 to 4 hours
Age 18 to 65
Ability to Understand questions and Literacy of Reading and Writing
Having a fixed line or Mobile phone and the Ability to make Phone calls</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No History of Kidney Transplantation in the past 6 months
Lack of Experience of a Stressful event within the last 6 months (Such as the death of a Family member or relative)
No Mental disorder
No vision or Hearing problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this stage, training will be given to the research units via mobile phone line twice a week for 3 months and each time for 20 minutes. The content of the conversations includes self-introduction, questions about the patient's general health status, encouraging the patient to follow the recommendations and aspects of general and dedicated self-care, follow-up of educational needs that will be based on the patient's educational needs checklist, and the patient will be provided with the necessary training and recommendations and answers to patients' questions.Phone calls and their content for each participant are recorded in certain sheets and at the end of the phone call with the patient's agreement the time of the next call is determined. The recorded file of the call will be sent to the patient by iGap or Soroush. Also, a text containing educational outline will be sent to the patient once a week.</i_keyword>
      <i_keyword>Control group: Lack of follow-up and telephone training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to the treatment regimen. Timepoint: Before the start of the study, after the training, after the intervention, for four months. Method of measurement: Dietary Adherence Questionnaire (ESRD-AQ).</prim_outcome>
      <prim_outcome>Monthly Tests. Timepoint: After intervention, monthly for up to four months. Method of measurement: Tests recorded in the patient's record.</prim_outcome>
      <prim_outcome>Weight gain between dialysis sessions. Timepoint: After intervention, monthly for up to four months. Method of measurement: Patient records.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-30</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini St., Ghadir Sq., Gonabad Medical Sciences Headquarters Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
