<?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>IRCT20241130063895N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-08</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Exploring the Collaborative Care Approach for Students with Type 1 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Impact of the Collaborative Care Model on Quality of Life and Self-Efficacy Among Students with Type 1 Diabetes: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, participants will be sampled using a convenience method. Subsequently, they will be allocated to two groups through a block randomization technique, Blinding description: In this method, considering the total number of 58 samples and the number of 2 study groups, the block size will be considered as a multiple of 2. Therefore, blocks of 2, 4, and 6 will be selected. Then, based on the online random assignment site, patients will be assigned to the test and comparison groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 1 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participatory care model is implemented with researcher management for the intervention group. The participatory care model in this study consists of four stages: motivation, preparation, engagement, and evaluation. Training in the motivation stage is carried out by informing patients about the disease and its dangerous consequences and outcomes with the cooperation of all team members and the client. In the next step, preparation, educational goals and the timing of the education programs and the method of follow-up are determined. Engagement is also implemented by holding 5 training sessions for the intervention group, and then evaluation is carried out after the intervention. Intervention 2: Control group: The control group does not receive any intervention.</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:
The only part of the data that can be shared is information related to the main outcome or similar aspects.

When:
Access begins 6 months after the publication of the results

To whom:
For researchers working in academic and scientific institutions, as well as in private and public clinics and hospitals.

Conditions:
Any use of published documents is permitted, provided that proper referencing is given.

Where to obtain:
Researcher: Simin Aghaei
Email: siminaghaee97@gmail.com
Address: Hazrat Zainab School of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran

How to obtain:
Any correspondence and requests will be addressed exclusively through the researcher's email and will be responded to within a maximum of two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Simin Aghaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rana Building, Corner of Hafez 12 Street, Hafez District, Dezful, Khuzestan</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461638538</zip>
        <telephone>+98 61 4242 9752</telephone>
        <email>siminaghaee97@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Simin Aghaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khuzestan, Dezful, Hafez District, Corner of Hafez 12 Street, Rana Building</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461638538</zip>
        <telephone>+98 61 4242 9752</telephone>
        <email>siminaghaee97@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants must be between 12 and 18 years old at the time of enrollment.
Participants must be currently enrolled as students in a primary or secondary school.
Participants must have a caregiver involved in their care and support.
The student and their caregiver must be mentally healthy and free from significant mental illnesses.
Participants must have a confirmed diagnosis of Type 1 diabetes made by a pediatrician.
Participants must have a confirmed diagnosis of Type 1 diabetes made by a pediatrician.
Participants must provide informed consent to participate in the study.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals who do not meet the inclusion criteria will be excluded.
Individuals with any other chronic illness will be excluded.
If either the child or the caregiver develops a mental illness during the study, they will be excluded.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participatory care model is implemented with researcher management for the intervention group. The participatory care model in this study consists of four stages: motivation, preparation, engagement, and evaluation. Training in the motivation stage is carried out by informing patients about the disease and its dangerous consequences and outcomes with the cooperation of all team members and the client. In the next step, preparation, educational goals and the timing of the education programs and the method of follow-up are determined. Engagement is also implemented by holding 5 training sessions for the intervention group, and then evaluation is carried out after the intervention.</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life Questionnaire Score (DQOLY). Timepoint: Measurement of quality of life score at the beginning of the study (before the intervention) and at the end of the fifth intervention session (sixth session). Method of measurement: Type 1 Diabetic Adolescent Quality of Life Questionnaire (DQOLY).</prim_outcome>
      <prim_outcome>Self-efficacy questionnaire for diabetic patients. Timepoint: Measuring self-efficacy scores at the beginning of the study (before the intervention) and at the end of the fifth intervention session (sixth session). Method of measurement: Self-efficacy questionnaire for diabetic patients.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-04</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Motahari Boulevard, Yasouj University of Medical Sciences, Education, Research and Technology Department Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
