<?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>IRCT20141027019694N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-03</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of diabetes self-care education on diabetes management</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of self-care training on the disease management of people with diabetes in prevention and health promotion clinics affiliated to Hamedan University of Medical Sciences in 2024</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74245</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the prevention and health promotion clinics, the specialists of the social medicine group provide face-to-face training for diabetic patients who refer to the centers after taking a comprehensive history, complete examinations and completing a comprehensive health file. The self-care education of patients in this study is direct and indirect. In direct education, social medical specialists teach patients the basic principles and how to self-care for diabetes in person and for one hour. Educational axes in the DSME approach with the aim of improving blood sugar control include reducing glycosylated hemoglobin and fasting blood sugar, as well as increasing patients' compliance in the correct use of medications and lifestyle modification in order to reduce complications and increase quality of life, and include the definition of the disease, a summary of the disease process, Complications of diabetes, ways to prevent complications, nutrition in diabetes, the need to exercise, how to perform physical activities, how and when to measure blood sugar by a diabetic person, medications and how to take them correctly and regularly, how to inject insulin and medication side effects, self-management of change Behavior and control of stress and quitting unhealthy behaviors from before such as smoking and alcohol consumption and the time and intervals of referrals to check eye, heart and kidney complications. Risk assessment is done for patients and preventive measures are recommended at different levels based on age and sex and risk level. Necessary screenings are also performed.  In indirect education, manuals and pamphlets and approved online sites are introduced to patients with various subjects of self-care education to study at home (study duration is about 2.5-3 hours). The duration of teaching patients is about four hours in total. Intervention 2: Control group: This group is only monitored for three months without receiving self-care training by social medical specialists.</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 is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
In order to compare with similar studies and perform meta-analysis

Where to obtain:
Azar PirDehghan, email: a.pirdehghan@umsha.ac.ir
Erfan Rajabi, email: erfanrajabi542@gmail.com

How to obtain:
The requester will send a message to the email and a response will be given within one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Erfan Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 35, Ghadir dead end, Sheghaiq Alley, Sanati St, Resalat Square</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515798737</zip>
        <telephone>+98 81 3822 1862</telephone>
        <email>erfanrajabi542@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azar Pirdehghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Community medicine department, Medical school, Hamadan University of medical sciences, Hamadan, Iran.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3838 0572</telephone>
        <email>a.pirdehghan@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of diabetes by a doctor (type 1 or type 2 diabetes)
At least 6 months have passed since the diagnosis of diabetes
Being literate in reading and writing in the patient
Age over ten years
Willingness to participate in the study</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a cognitive problem
Suffering from serious and debilitating complications caused by diabetes, such as severe kidney failure, heart failure, blindness, etc
Having concurrent diseases (comorbidity)
Use of immunosuppressive drugs and corticosteroids</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the prevention and health promotion clinics, the specialists of the social medicine group provide face-to-face training for diabetic patients who refer to the centers after taking a comprehensive history, complete examinations and completing a comprehensive health file. The self-care education of patients in this study is direct and indirect. In direct education, social medical specialists teach patients the basic principles and how to self-care for diabetes in person and for one hour. Educational axes in the DSME approach with the aim of improving blood sugar control include reducing glycosylated hemoglobin and fasting blood sugar, as well as increasing patients' compliance in the correct use of medications and lifestyle modification in order to reduce complications and increase quality of life, and include the definition of the disease, a summary of the disease process, Complications of diabetes, ways to prevent complications, nutrition in diabetes, the need to exercise, how to perform physical activities, how and when to measure blood sugar by a diabetic person, medications and how to take them correctly and regularly, how to inject insulin and medication side effects, self-management of change Behavior and control of stress and quitting unhealthy behaviors from before such as smoking and alcohol consumption and the time and intervals of referrals to check eye, heart and kidney complications. Risk assessment is done for patients and preventive measures are recommended at different levels based on age and sex and risk level. Necessary screenings are also performed.  In indirect education, manuals and pamphlets and approved online sites are introduced to patients with various subjects of self-care education to study at home (study duration is about 2.5-3 hours). The duration of teaching patients is about four hours in total.</i_keyword>
      <i_keyword>Control group: This group is only monitored for three months without receiving self-care training by social medical specialists.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The self-care score in the diabetes self-care questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the self-care training. Method of measurement: Diabetic self-care questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: At the beginning of the study and three months after the self-care training. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Foot care status. Timepoint: At the beginning of the study and three months after the self-care training. Method of measurement: Foot care status questionnaire.</sec_outcome>
      <sec_outcome>Adherence to the Mediterranean diet. Timepoint: At the beginning of the study and three months after the self-care training. Method of measurement: Mediterranean diet compliance questionnaire.</sec_outcome>
      <sec_outcome>Physical activity status. Timepoint: At the beginning of the study and three months after the self-care training. Method of measurement: Physical activity questionnaire.</sec_outcome>
      <sec_outcome>Medication adherence. Timepoint: At the beginning of the study and three months after the self-care training. Method of measurement: Medication compliance questionnaire.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-05</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>address: Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St. zip code: 6517838736 Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
