<?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>IRCT20130428013152N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-22</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the nurse follow - up plan and its effect on self-care and metabolic control indices in diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the nurse follow - up plan and its effect on self-care and metabolic control indices in diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56229</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: The follow-up nurse project is being piloted at two medical universities, Randomization description: Randomization by stratified random replacement blocks. Classes are based on three age groups (less than or equal to 45 years, 46 to 64 years, 65 years and more) and gender (male and female) that are created in a set of 6 classes. Randomization within each floor is done in the style of random replacement blocks with sizes 2 and 4. The list will be determined by the web analytics.
   In order to privatize the properties, opaque envelopes will be stamped using a random sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Routine hospital care including discharge from the hospital and training during discharge by the patient nurse and return to the self-care clinic after 3 months. Intervention 2: Intervention group: Follow-up nurse care plan including: performing safe discharge steps, introducing the patient to the follow-up nurse and sending his case summary. The patient's number is called the day after discharge. After contacting the patient and introducing yourself, based on the relevant checklist, the necessary follow-up is done and in any case where the patient needed further and supplementary training, recommendations are given. Also, if the patient needs support resources such as diabetes clinic, hospital self-care clinic, health centers, psychologist, addiction and smoking cessation centers, nutrition counselor and home care centers and referral until complete reassurance, the necessary follow-ups are done with the mentioned institutions. Frequency of follow-up is determined based on the severity of the disease and danger signs according to the instructions from three days to one year after discharge as follows: 1. Green area: Follow-up frequency of patients in the green area should be done twice as a fish. 2. Yellow area Frequent follow-up of patients in the yellow area should be done once a week. Red area: While advising to go to the hospital emergency room immediately, a follow-up should be done by phone up to 6 hours later. Follow-up of these patients is done twice a week after discharge from the hospital until they are in the green area.</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:
All data related to the main consequences can be shared.

When:
6 months after printing the results

To whom:
Data will be available to all researchers

Conditions:
The data will be usable for further studies and improving patient care

Where to obtain:
Elham Saberi Noghabi
saberi.e@gmu.ac.ir

How to obtain:
6 months after the publication of the results of the study, the applicant can submit a valid letter of introduction from an organization to the e-mail of Ms. Elham Saberi Noghabi and can request the data and the data file will be provided to her within two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Saberi Noghabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parstar Ave., Gonabad University of Medical Sciences</address>
        <city>gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>saberi.e@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Saberi Noghabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parstar St., Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>009685157223028</telephone>
        <email>saberi.e@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of diabetes by a specialist doctor
Discharged from the hospital and referred to the self-care and follow-up unit of the hospital
Age over 18 years
Informed consent
Access to phone or mobile
No speech, hearing and vision disorders and the ability to understand and answer questions
Resident of Gonabad city
No history of mental illness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Routine hospital care including discharge from the hospital and training during discharge by the patient nurse and return to the self-care clinic after 3 months</i_keyword>
      <i_keyword>Intervention group: Follow-up nurse care plan including: performing safe discharge steps, introducing the patient to the follow-up nurse and sending his case summary. The patient's number is called the day after discharge. After contacting the patient and introducing yourself, based on the relevant checklist, the necessary follow-up is done and in any case where the patient needed further and supplementary training, recommendations are given. Also, if the patient needs support resources such as diabetes clinic, hospital self-care clinic, health centers, psychologist, addiction and smoking cessation centers, nutrition counselor and home care centers and referral until complete reassurance, the necessary follow-ups are done with the mentioned institutions. Frequency of follow-up is determined based on the severity of the disease and danger signs according to the instructions from three days to one year after discharge as follows: 1. Green area: Follow-up frequency of patients in the green area should be done twice as a fish. 2. Yellow area Frequent follow-up of patients in the yellow area should be done once a week. Red area: While advising to go to the hospital emergency room immediately, a follow-up should be done by phone up to 6 hours later. Follow-up of these patients is done twice a week after discharge from the hospital until they are in the green area.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Diabetes Self-Care Questionnaire (F-SCODI).</prim_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Laboratory Kit.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Laboratory Kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Laboratory Kit.</prim_outcome>
      <prim_outcome>Glycosylated hemoglobin. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Laboratory Kit.</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>2021-05-08</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Parastar Ave, Gonabad Town Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
