<?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>IRCT20200207046403N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-06</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of peer education on blood glucose management and self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of peer education compared to Common Education on the  children's blood glucose management and self-efficacy of mothers having preschool children with type 1 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using a simple random sampling method: In this way, a number will be assigned to all the names of the people in the prepared list. The number assigned to each person is written on a piece of paper. All the sheets are mixed together in a container. The first number that is randomly selected from all the numbers will be placed in the control group and the next numbers will be placed is in the peer group with a child with diabetes and the peer group with diabetes, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Control Group receives the usual hospital training which is held by a diabetes education expert. Research samples in the control group in accordance with the routine of the hospital will visit on Tuesday for training, which includes a 4 -hour session with titles: diabetes, blood glucose control method, insulin injection, and dietary control necessities, the methods of control the complications of the disease. All mothers participating in this group are added to one of the virtual messengers formed by the hospital education expert to keep in mind the conditions of the child and the mother and the lack of child or parent diseases. Intervention 2: Intervention group 1: The recipient of the training by the parent with a child with type 1 diabetes. The second number that is randomly taken out from the numbers inside the container is placed in the second intervention group. They come to class on Monday to avoid leakage of information. When parents come to the clinic, written consent is obtained from the parent at first. Then they participate in the classes held by a peer who has a child with type 1 diabetes who met the criteria for entering the study as a peer educator (having a young child with type 1 diabetes; having a diploma or higher; Iranian and resident of Isfahan; ability to conduct meetings and provide training; having the ability and interest in group training). The peer educator will also receive training from the research team (Three two-hour sessions including the definition of the peer and the purpose of doing the work - the principles of diabetes education, answering the questions of the peers - expressing the peer's experiences in each case, checking the ability to practically do each case). In addition, she/he must get a higher score according to the questionnaire of peer coaches made by the researcher, the opinion of the endocrinologist and based on the evidence in the documents such as the results of the tests and periodical examinations of the diabetes specialist in terms of the occurrence of diabetes complications and keeping the child's blood sugar within the normal range and being successful in managing the disease. The second group receives training provided by the peer who has a child with type 1 diabetes which will be held in three two-hour sessions, including the blood sugar check method, insulin injection, diet, disease complications, the practical implementation of the above things and the experiences of peer trainers in each of the above cases. The researcher will be present in all the meetings in order to provide the possibility of holding and monitoring the implementation of the meetings. Also, if this research method is effective for the intervention groups, after the completion of the study, meetings with the same method will be held for the control group. All mothers participating in this group are added to one of the virtual messengers formed by the peer educator who has a young diabetic child to follow up the conditions of the child and the mother. Intervention 3: Intervention group 2: The recipient of education by a peer suffering from type 1 diabetes. The third number that is randomly taken from the numbers inside the container is placed in the third intervention group. They visit on Wednesdays to prevent information leakage. At the time of referral, a written consent  obtained from the parent first, then participate In the classes held by a peer has type 1 diabetes who met the criteria for entering the study as a peer educator (having type 1 diabetes; having a diploma or higher; Iranian and resident of Isfahan; Ability to conduct meetings and provide training; Having the ability and interest in group training) She has also received training from the research team(Three two-hour sessions including the definition of the peer and the purpose of doing the work - the principles of diabetes education, answering the questions of the peers - expressing the peer's experiences in each case, checking the ability to practically do each case) and According to the questionnaire of peer coaches made by the researcher, they got a higher score Also, according to the opinion of the endocrinologist and based on the evidence in the file, such as: the results of the tests and periodical examinations of the diabetes specialist in terms of the occurrence of diabetes complications and keeping their child's blood sugar within the normal range, they have been successful in managing the disease. The third group receives training provided by a peer who has type 1 diabetes these trainings are held in three two-hour sessions, including the blood sugar check method, insulin injection, diet, disease complications, the practical implementation of the above, and the experiences of peer trainers in each of the above cases. The researcher will be present in all the meetings in order to provide the possibility of holding and monitoring the implementation of the meetings. Also, if this research is effective for the intervention groups, after the completion of the study, meetings with the same method will be held for the control group. All mothers participating in this group are added to one of the virtual messengers formed by the peer educator who had type 1 diabetes to keep in mind the conditions of the child and the mother and the lack of child or parent diseases.</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:
Total individual data after de-identification and parental self-efficacy and glycemic management data

When:
The start of the 6-month access period after the results are published

To whom:
Researchers working in scientific institutions

Conditions:
There are no special conditions

Where to obtain:
Email to this email address f.joonbakhsh@nm.mui.ac.ir

How to obtain:
First, she/he sends the request email and after checking the request, the answer and data will be provided to her/him

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Joonbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room number 158; Faculty of Nursing and Midwifery; Isfahan University of Medical Sciences; Hazar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>f.joonbakhsh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Joonbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room number 158; Faculty of Nursing and Midwifery; Isfahan University of Medical Sciences; Hazar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>f.joonbakhsh@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definite diabetes diagnosis by a pediatric endocrinologist
Being the Child in the age range of 3 to 6 years
Absence of an evolutionary disorder or other chronic illnesses in child
The ability to read and write by parents
Passing at least three days and a maximum of one month of diagnosis of diabetes
Not participation of parents in other educational programs related to child care with diabetes
Parents' awareness of child's disease (type 1 diabetes)</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents are involved in other processes that require child care, such as hospitalization of the child or parent
The parents' discontent to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus without complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group receives the usual hospital training which is held by a diabetes education expert. Research samples in the control group in accordance with the routine of the hospital will visit on Tuesday for training, which includes a 4 -hour session with titles: diabetes, blood glucose control method, insulin injection, and dietary control necessities, the methods of control the complications of the disease. All mothers participating in this group are added to one of the virtual messengers formed by the hospital education expert to keep in mind the conditions of the child and the mother and the lack of child or parent diseases.</i_keyword>
      <i_keyword>Intervention group 1: The recipient of the training by the parent with a child with type 1 diabetes. The second number that is randomly taken out from the numbers inside the container is placed in the second intervention group. They come to class on Monday to avoid leakage of information. When parents come to the clinic, written consent is obtained from the parent at first. Then they participate in the classes held by a peer who has a child with type 1 diabetes who met the criteria for entering the study as a peer educator (having a young child with type 1 diabetes; having a diploma or higher; Iranian and resident of Isfahan; ability to conduct meetings and provide training; having the ability and interest in group training). The peer educator will also receive training from the research team (Three two-hour sessions including the definition of the peer and the purpose of doing the work - the principles of diabetes education, answering the questions of the peers - expressing the peer's experiences in each case, checking the ability to practically do each case). In addition, she/he must get a higher score according to the questionnaire of peer coaches made by the researcher, the opinion of the endocrinologist and based on the evidence in the documents such as the results of the tests and periodical examinations of the diabetes specialist in terms of the occurrence of diabetes complications and keeping the child's blood sugar within the normal range and being successful in managing the disease. The second group receives training provided by the peer who has a child with type 1 diabetes which will be held in three two-hour sessions, including the blood sugar check method, insulin injection, diet, disease complications, the practical implementation of the above things and the experiences of peer trainers in each of the above cases. The researcher will be present in all the meetings in order to provide the possibility of holding and monitoring the implementation of the meetings. Also, if this research method is effective for the intervention groups, after the completion of the study, meetings with the same method will be held for the control group. All mothers participating in this group are added to one of the virtual messengers formed by the peer educator who has a young diabetic child to follow up the conditions of the child and the mother.</i_keyword>
      <i_keyword>Intervention group 2: The recipient of education by a peer suffering from type 1 diabetes. The third number that is randomly taken from the numbers inside the container is placed in the third intervention group. They visit on Wednesdays to prevent information leakage. At the time of referral, a written consent  obtained from the parent first, then participate In the classes held by a peer has type 1 diabetes who met the criteria for entering the study as a peer educator (having type 1 diabetes; having a diploma or higher; Iranian and resident of Isfahan; Ability to conduct meetings and provide training; Having the ability and interest in group training) She has also received training from the research team(Three two-hour sessions including the definition of the peer and the purpose of doing the work - the principles of diabetes education, answering the questions of the peers - expressing the peer's experiences in each case, checking the ability to practically do each case) and According to the questionnaire of peer coaches made by the researcher, they got a higher score Also, according to the opinion of the endocrinologist and based on the evidence in the file, such as: the results of the tests and periodical examinations of the diabetes specialist in terms of the occurrence of diabetes complications and keeping their child's blood sugar within the normal range, they have been successful in managing the disease. The third group receives training provided by a peer who has type 1 diabetes these trainings are held in three two-hour sessions, including the blood sugar check method, insulin injection, diet, disease complications, the practical implementation of the above, and the experiences of peer trainers in each of the above cases. The researcher will be present in all the meetings in order to provide the possibility of holding and monitoring the implementation of the meetings. Also, if this research is effective for the intervention groups, after the completion of the study, meetings with the same method will be held for the control group. All mothers participating in this group are added to one of the virtual messengers formed by the peer educator who had type 1 diabetes to keep in mind the conditions of the child and the mother and the lack of child or parent diseases.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score based on researcher-made questionnaire. Timepoint: At the beginning of the study, one and three months after the intervention. Method of measurement: Self-efficacy questionnaire developed by the researcher.</prim_outcome>
      <prim_outcome>The blood sugar management score is based on the researcher's checklist. Timepoint: At the beginning of the study, one and three months after the intervention. Method of measurement: Checklist made by the researcher.</prim_outcome>
      <prim_outcome>HBA1C value based on experiment. Timepoint: Before starting the intervention and three months after the intervention. Method of measurement: Using the A1C Clover device.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-22</approval_date>
        <contact_name>Ethics committee of Faculty of Nursing, Management and Rehabilitation, Isfahan University of Medical</contact_name>
        <contact_address>Hazar Jarib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
