<?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>IRCT20170625034743N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-05</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluate the effect of peer digital storytelling on depression, emotional distress and burnout of patients with type 1 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluate the effect of peer digital storytelling on depression, emotional distress and burnout of patients with type 1 diabetes referring to selected health centers in Isfahan in 2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is done in two steps. First, as a cluster of centers covered by comprehensive health service centers in the city of Isfahan, according to the equality of the covered centers, 5 centers are randomly selected (lottery) and if no sample is provided, one center is randomly added.
Then, from each center according to the proportional allocation method (based on the ratio of type 1 diabetic patients covered by that center to the total number of diabetic patients in the selected centers, this ratio is observed in the sampling) through the Sib system and from Al Ibrahim's specialized clinic. Through the existing list, eligible patients are selected to enter the study and are randomly placed into two experimental and control groups through the software, Blinding description: The researcher who conducts the data analysis will be unaware of the control and intervention groups and will analyze the data that has been coded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 1 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the participants complete demographic, depression, emotional distress, and diabetes burnout questionnaires before starting the study, and then receive peer digital stories during 4 weekly sessions. Immediately and one month after the end of the intervention, the questionnaires are filled out again by the participants. Intervention 2: Control group: In the control group, demographic, depression, emotional distress, and diabetes burnout questionnaires are completed before the start of the study, and the participants receive the usual care and counseling provided by health centers and clinics. At the end (immediately and one month after the end of the intervention) depression, emotional distress and diabetes burnout questionnaires are completed again by the participants. At the end of the study, digital stories will be provided to the control group.</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 collected data will be published in a paper.

When:
1 year after study

To whom:
Reviewers and authors of the article

Conditions:
Data are available from the authors upon reasonable request with the permission of [name of third party].

Where to obtain:
corresponding author

How to obtain:
Request from corresponding author through an email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sheyda Zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7541</telephone>
        <email>sheydazamani1377new@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Mardanian Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7541</telephone>
        <email>leila.mardanian@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Adults with type 1 diabetes for at least 6 months                                                             2. Willingness to participate in research                                                                                 3. Persian-speaking                                                                                                                 4. Lack of physical disability such as blindness or deafness                                               5. Not taking psychiatric drugs                                                                                               6. Minimum reading and writing literacy                                                                               7. Access to social media and access to the Internet                                                          8. No addiction to drugs, psychedelics and alcohol                                                                                                         9. No disease besides diabetes as approved by the attending physician and according to the contents of the medical file</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the participants complete demographic, depression, emotional distress, and diabetes burnout questionnaires before starting the study, and then receive peer digital stories during 4 weekly sessions. Immediately and one month after the end of the intervention, the questionnaires are filled out again by the participants.</i_keyword>
      <i_keyword>Control group: In the control group, demographic, depression, emotional distress, and diabetes burnout questionnaires are completed before the start of the study, and the participants receive the usual care and counseling provided by health centers and clinics. At the end (immediately and one month after the end of the intervention) depression, emotional distress and diabetes burnout questionnaires are completed again by the participants. At the end of the study, digital stories will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diabetes burnout. Timepoint: Before intervention and quickly and one month after intervention. Method of measurement: Diabetes burnout questionnaire.</prim_outcome>
      <prim_outcome>Diabetes emotional distress. Timepoint: Before intervention and quickly and one month after intervention. Method of measurement: Diabetes distress questionnaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before intervention and quickly and one month after intervention. Method of measurement: Beck depression 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-25</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezarjarib Street, Isfahan University of Medical Sciences, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
