<?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>IRCT20180730040641N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-18</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Collaborative Care Model On Self-Efficacy and Dietary Adherence on Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Collaborative Care Model On Self-Efficacy and Dietary Adherence on Hemodialysis Patients Referred To Taleghani Educational Hospital Center In  Urmia In 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40545</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method in this study is random selection (drawn randomly) of patients referring to odd days and even days of the week as control and intervention groups and then based on entry and exit criteria, patients in odd days and even days of the week are simple randomly selected from the list of patient names, Blinding description: Patients selected for intervention and control groups referring hemodialysis on different days, so the control and intervention group has no relationship with each other. Data entry into Spss software and analysis of results is done by another researcher, who is not involved in data collection and does not know the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diet and nutrition for Haemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Collaborative care model steps are implemented in interventional patients in 7 sessions. In order to achieve the objectives of the model, the steps include 4 steps: 1- Motivation, 2- Preparation, 3. Fighting, 4. Evaluation, which will be foreseen for each stage of the actual program. Based on estimated hemodialysis time in the hospital, a questionnaire for patients in each group will be completed. Motivation Stage: In order to stimulate patients by establishing appropriate communication with them, familiarizing them with the available area and facilities, informing patients about chronic renal failure, its consequences and its harmful consequences will be briefly discussed. Educational needs assessment will be done by examining and identifying the patient's problems by taking a biography and conducting an interview, which will be completed during a session after filling the questionnaire during the course of the hemodialysis for 2 hours. Preparatory phase: The objectives of the model and timing of participatory training programs and follow-up will be determined (one-hour session). Fighting stage: Training sessions and follow-up sessions will be held at this stage (each session for 45 minutes), which includes: 1) the first collaborative training session 2) the second training coaching session 3) the first follow-up participation meeting 4) the second phase follow-up meeting Evaluation: Achievement of goals will be evaluated in the implementation stages of the model, and this assessment will be carried out in stages at the beginning and end of each training session. The steps in teaching the content will be simple and lecture-less. Implementation of the educational program in the stage of engagement in the form of 4 sessions in the classroom located in the hemodialysis department of Taleghani Educational Center of Urmia for 45 minutes individually and separately for patients. Educational information will also be provided in the form of pamphlets and educational pamphlets. The questionnaire is again completed immediately at the last session (third session) and two months later by the patients. The average of the parameters of the laboratory parameters will be examined at the beginning and two months after the end of the intervention. Meanwhile, the contents of the pediatric hemodialysis nursing books and nurses and the instruction book are approved by the doctors and nursing practitioners. Intervention 2: Control group: Training and regular dietary consultations are provided by the department.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Pardis Nazlou, 11 km of Nazlou Road,Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>kazemi.s@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Habibzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing. School of Nursing and Midwifery, Nazlou Campus, Urmia University of Medical Sciences, Urmia,IRAN</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>habibzadeh.h@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lack of cognitive and psychological diseases based on patient records
The ability to stand on the weight
Have at least reading and writing skills
Pass a minimum of three months from the start of hemodialysis</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwilling to continue participating in the study
Hospitalization due to other diseases
Patient death</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Collaborative care model steps are implemented in interventional patients in 7 sessions. In order to achieve the objectives of the model, the steps include 4 steps: 1- Motivation, 2- Preparation, 3. Fighting, 4. Evaluation, which will be foreseen for each stage of the actual program. Based on estimated hemodialysis time in the hospital, a questionnaire for patients in each group will be completed. Motivation Stage: In order to stimulate patients by establishing appropriate communication with them, familiarizing them with the available area and facilities, informing patients about chronic renal failure, its consequences and its harmful consequences will be briefly discussed. Educational needs assessment will be done by examining and identifying the patient's problems by taking a biography and conducting an interview, which will be completed during a session after filling the questionnaire during the course of the hemodialysis for 2 hours. Preparatory phase: The objectives of the model and timing of participatory training programs and follow-up will be determined (one-hour session). Fighting stage: Training sessions and follow-up sessions will be held at this stage (each session for 45 minutes), which includes: 1) the first collaborative training session 2) the second training coaching session 3) the first follow-up participation meeting 4) the second phase follow-up meeting Evaluation: Achievement of goals will be evaluated in the implementation stages of the model, and this assessment will be carried out in stages at the beginning and end of each training session. The steps in teaching the content will be simple and lecture-less. Implementation of the educational program in the stage of engagement in the form of 4 sessions in the classroom located in the hemodialysis department of Taleghani Educational Center of Urmia for 45 minutes individually and separately for patients. Educational information will also be provided in the form of pamphlets and educational pamphlets. The questionnaire is again completed immediately at the last session (third session) and two months later by the patients. The average of the parameters of the laboratory parameters will be examined at the beginning and two months after the end of the intervention. Meanwhile, the contents of the pediatric hemodialysis nursing books and nurses and the instruction book are approved by the doctors and nursing practitioners.</i_keyword>
      <i_keyword>Control group: Training and regular dietary consultations are provided by the department.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean self-efficacy score based on self-efficacy questionnaire. Timepoint: At the beginning of the study and after the end of the intervention two months later. Method of measurement: based on self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Adherence to the diet. Timepoint: At the beginning of the study and after the end of the intervention two months later. Method of measurement: Renal Adherence Behavior Questionnaire.</prim_outcome>
      <prim_outcome>Laboratory Parameters (Sodium, Potassium, Phosphorus, Protein). Timepoint: First and 2 months after the end of the intervention. Method of measurement: blood test.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-05</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
