<?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>IRCT20210114050037N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-03-26</date_registration>
      <primary_sponsor>Gerash University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of self-care education based on the family-centered empowerment model on self-management, self-care, and readmission rates of patients with diabetic keto acidosis</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of self-care education based on the family-centered empowerment model on self-management, self-care, and readmission rates of patients with diabetic ketoacidosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>136</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After determining the sample size, since patients enter the study gradually, the block randomization method will be used to assign participants to the control or intervention groups. In this method, considering the sample size of 136participants and 22 participants per block, we will need 6 blocks. All possible block permutations  include AABB, ABAB, ABBA, BAAB, BABA, and BBAA. Then, a number from 1 to 6 will be randomly selected, and allocation will begin with that block. The subsequent blocks will also be selected and completed in the same manner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Keto Acidosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Families and patients in this group are impacted by self-care education regarding diabetic ketoacidosis.In this way, the researcher provides face-to-face education for the companions of patients in the intervention group for three days about diabetes and its important complication, ketoacidosis, and strategies for preventing and dealing with it, with each session lasting approximately half an hour. After each session, the researcher asks the patient's companion to give his or her feedback on the information provided and to clarify any ambiguity. In addition, the patient's companion is asked to convey the information to the patient when he or she has enough energy and patience.The educational content of these three sessions is as follows: Session 1: Introduction to diabetes, its types, and proper diet adherence Session 2: How to use and store insulin (with an educational video) and, if taking oral diabetes medications, related training Session 3: Self-monitoring of blood sugar and familiarization with the symptoms of low or high blood sugar and strategies for dealing with it It should be noted that the content of the educational sessions will be collected from the book by Bruner and Suddarth, reputable websites and articles related to diabetes. After the intervention, patients and family members were given three months to take care of themselves and keep their disease under control based on the skills acquired in the educational sessions. Intervention 2: Control group: Patients in this group will only undergo routine ward 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali asghar Rahmanian Kushkaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein (AS) Blvd., Daneshjoo Blvd., Garash Faculty of Medical Sciences</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441758666</zip>
        <telephone>+98 71 5244 8101</telephone>
        <email>info@gerums.ac.ir</email>
        <affiliation>Gerash University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali asghar Rahmanian Kushkaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein (AS) Blvd., Daneshjoo Blvd., Garash Faculty of Medical Sciences</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441758666</zip>
        <telephone>+98 71 5244 8101</telephone>
        <email>Lynurse8@gmail.com</email>
        <affiliation>Gerash University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of diabetes according to the opinion of an internist or endocrinologist
Having an active companion and a close relative of the patient to participate in the implementation of the intervention, who is fully aware of her illness and is concerned about her treatment.
Having a minimum level of literacy to be able to read and understand the content in the uploaded clips.
Aware of time and place, able to understand Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having advanced malignant diseases such as various types of cancer, chronic kidney disease, and advanced heart disease
Failure to attend training session
His/her feeling unwell during the training period
Unwillingness to continue cooperation
death of the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus with ketoacidosis without coma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Families and patients in this group are impacted by self-care education regarding diabetic ketoacidosis.In this way, the researcher provides face-to-face education for the companions of patients in the intervention group for three days about diabetes and its important complication, ketoacidosis, and strategies for preventing and dealing with it, with each session lasting approximately half an hour. After each session, the researcher asks the patient's companion to give his or her feedback on the information provided and to clarify any ambiguity. In addition, the patient's companion is asked to convey the information to the patient when he or she has enough energy and patience.The educational content of these three sessions is as follows: Session 1: Introduction to diabetes, its types, and proper diet adherence Session 2: How to use and store insulin (with an educational video) and, if taking oral diabetes medications, related training Session 3: Self-monitoring of blood sugar and familiarization with the symptoms of low or high blood sugar and strategies for dealing with it It should be noted that the content of the educational sessions will be collected from the book by Bruner and Suddarth, reputable websites and articles related to diabetes. After the intervention, patients and family members were given three months to take care of themselves and keep their disease under control based on the skills acquired in the educational sessions.</i_keyword>
      <i_keyword>Control group: Patients in this group will only undergo routine ward training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of self-care training based on the family-centered empowerment model. Timepoint: Measuring the level of self-management before the start of the intervention and one month after the intervention. Method of measurement: Diabetes self-management questionnaire.</prim_outcome>
      <prim_outcome>Measuring self-care. Timepoint: Before the start of the intervention and one month after the intervention. Method of measurement: Self-care Activities Summary Questionnaire.</prim_outcome>
      <prim_outcome>Readmission rate. Timepoint: Before and one month after the intervention. Method of measurement: Demographic information 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>Gerash University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-25</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medical Sciences, Garash</contact_name>
        <contact_address>Gerash City, Imam Hussein Blvd., Daneshjoo Blvd., Gerash Faculty of Medical Sciences Gerash Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
