<?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>IRCT20220815055701N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-15</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of telenursing on the knowledge and self-care performance of patients with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of effectiveness of telenursing on the awareness and self-care performance of  patients with diabetes in the conditions of the COVID-19 pandemic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65275</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 1. The number of files in the diabetes clinic is 1967 files. The researcher will select 320 files by systematic sampling method, in such a way that a number is randomly selected from one to six to determine the first selected file. The researcher moves in the list of files by adding the number six each time until finally 320 files are selected.  
2. After identifying the files, the researcher will select the final patients according to the Inclusion and exclusion criteria. Then the selected patients are contacted by phone and invited to participate in the study.  
3. The objectives of the study will be explained to the patients who express their desire to participate in the study. The researcher will explain to the patients about the intervention group and the control group, and the patients will be told that they will be randomly assigned to one of these two groups.
4. After reaching the quorum of the number of patients who want to    participate in the study, these people will be assigned to two intervention and control groups using random numbers obtained from the Excel program.
5. By using the simple randomization method from the Excel program, a sequence of 100 people (control group-intervention group) of numbers less than one (0_1) will be created. Numbers that are more than 0/5 are placed in one group and numbers that are less than 0/5 are placed in another group. The researcher contacts the patients based on this sequence.
6. The randomization unit in this study is the patients with files that are willing to participate in the study .
7. The randomization tool in this study is the sequence generated by excel program .
8. Allocation concealment will not be done in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Type 1 diabetes mellitus. Condition 2: Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During 8 sessions, the necessary training will be provided to patients with diabetes to take care of themselves and how to function in Corona conditions using the phone and social messenger, two days a week for one month. After holding each educational session and teaching the designated topic to the patients, the educational content will be sent to them through social messenger and they are requested to raise their questions through phone call or social messenger in case of any ambiguity and problems. In each session, the patient will be asked questions about the educational topic of the previous session and  troubleshooting will be done. The time of each group meeting will be determined by asking the research unit from 8:00 am to 8:00 pm on non-holiday days. The duration of each session is on average twenty minutes .The educational topic of each session is as follows:                                                                                 First session: diabetes - complications of diabetes - foot care in diabetic patients                                                                                                                Second session: what diabetic patients should know about Covid-19                                                                                                                Third session: personal hygiene and use of equipment Personal protection during the corona pandemic                                                                     Session 4: Vaccination against covid 19                                                                           Session 5: Factors affecting blood sugar in patients with diabetes during the corona pandemic                                                                                                                Session 6: Management of diabetes during covid 19 disease                                      Session 7: Diet in patients with diabetes Especially in the corona pandemic                                                                                                                The eighth session: sports activities in patients with diabetes with an emphasis on the corona pandemic. Intervention 2: Control group: In the control group, no intervention will be done and only to comply with the ethical standards, a pre-prepared brochure will be  provided to them regarding the necessary information in the corona pandemic.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akhtar Dehghani Manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr School of Nursing and Midwifery, Campus Complex of Bushehr University of Medical Sciences, after Salman Farsi Hospital (Social Security), Salman Farsi Street, Sabzabad Boulevard,  Bahmani, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0084</telephone>
        <email>adehghani1202@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akhtar Dehghani Manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr School of Nursing and Midwifery, Campus Complex of Bushehr University of Medical Sciences, after Salman Farsi Hospital (Social Security), Salman Farsi Street, Sabzabad Boulevard,  Bahmani, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0084</telephone>
        <email>adehghani1202@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have an active file in Bushehr diabetes clinic.
At least they should be able to read and write.
Have a smartphone.
Have the possibility to connect to the Internet.
Do not have a known mental disorder according to the person's statement.
Do not have known speech and hearing problems.
The age of the patient should be over 18 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient is pregnant.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10</hc_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 1 diabetes mellitus</hc_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: During 8 sessions, the necessary training will be provided to patients with diabetes to take care of themselves and how to function in Corona conditions using the phone and social messenger, two days a week for one month. After holding each educational session and teaching the designated topic to the patients, the educational content will be sent to them through social messenger and they are requested to raise their questions through phone call or social messenger in case of any ambiguity and problems. In each session, the patient will be asked questions about the educational topic of the previous session and  troubleshooting will be done. The time of each group meeting will be determined by asking the research unit from 8:00 am to 8:00 pm on non-holiday days. The duration of each session is on average twenty minutes .The educational topic of each session is as follows:                                                                                 First session: diabetes - complications of diabetes - foot care in diabetic patients                                                                                                                Second session: what diabetic patients should know about Covid-19                                                                                                                Third session: personal hygiene and use of equipment Personal protection during the corona pandemic                                                                     Session 4: Vaccination against covid 19                                                                           Session 5: Factors affecting blood sugar in patients with diabetes during the corona pandemic                                                                                                                Session 6: Management of diabetes during covid 19 disease                                      Session 7: Diet in patients with diabetes Especially in the corona pandemic                                                                                                                The eighth session: sports activities in patients with diabetes with an emphasis on the corona pandemic.</i_keyword>
      <i_keyword>Control group: In the control group, no intervention will be done and only to comply with the ethical standards, a pre-prepared brochure will be  provided to them regarding the necessary information in the corona pandemic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Awareness. Timepoint: Before the start of the intervention, immediately after the end of the intervention, one month after the end of the intervention. Method of measurement: A researcher-made questionnaire on awareness and self-care performance of patients with diabetes in the conditions of the coronavirus pandemic, which has 56 items.</prim_outcome>
      <prim_outcome>Self-care performance. Timepoint: Before the start of the intervention, immediately after the end of the intervention, one month after the end of the intervention. Method of measurement: A researcher-made questionnaire on awareness and self-care performance of patients with diabetes in the conditions of the coronavirus pandemic, which has 56 items.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-12</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Research Ethics Committee, 1st Floor, Bushehr Medical Sciences Campus, Salman Farsi St. , Bahmani, Bushehr, Iran Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
