<?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>IRCT20170611034454N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-15</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Mobile phone-based self-care in diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>To assess the effectiveness of the education based on the Idia application on the self-care behaviors of the elderly with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71072</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants will be randomly assigned into two intervention and control groups. Based on this, all people are numbered from 1 to 102. Then 51 cards with white color and 51 cards with red color without numbers are prepared and placed in a container. Then, one card for each person is randomly selected from the container and assigned to each number. If the color of the card is red, the person is assigned to the intervention group, and if it is white, the person is assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After selecting the participants of the intervention group, they are invited to visit the Mustafavian diabetes clinic in Sari. In this meeting, the researcher will first introduce himself, explain the objectives of the study and obtain written informed consent. Then the desired questionnaires are completed with the help of the researcher. FBS and HbA1c tests will be taken from patients. At the end of the session, Idea software is installed for the participants of the intervention group and its performance is controlled on the phone, and with the cooperation of the patient, how to use and use it by an experienced expert (with education and experience in the field of planning and development) It will be given. If possible, it is suggested to the participants of the intervention group that a family member accompanies them in face-to-face and non-face-to-face training sessions to facilitate the process of working with Idea software. Also, along with the installed program, a pamphlet will be presented to the users, which is a guide for using the program, and it will be explained to the participants that whenever they encounter a problem during the intervention period, they can contact the researcher (a number that is available 24 hours a day). It is provided to the elderly to answer their questions. This software will allow patients to manually record diabetes self-care data (nutritional information, blood sugar records, insulin and medication records, physical activity records, emotion records) on the mobile phone, and trainings Receive information related to diabetes self-care through the software. Also, once a week, along with measuring blood sugar by the researcher, the weight of the patients will be measured using a scale and recorded in the program. The training of the participants in the intervention group will be in the form of two sessions in person and 8 sessions in person. It will be held twice a week (Mondays and Wednesdays) in the period of 15-18 on the chat page of the Idea program as a group. In this way, the educational content in the form of PDF, the recorded voice of the researcher and the educational video will be sent to the participants at 15:00 and they are requested to read the content. The researcher will have access to all the information recorded by the participants through the Idea software database and will be informed indirectly about the treatment plan and lifestyle of the patients. Also, the researcher will follow up the participants during their participation in the training sessions. Intervention 2: Control group: After selecting the participants of the control group, they are invited to visit the Mustafavian diabetes clinic in Sari. In this meeting, the researcher will first introduce himself, explain the objectives of the study and obtain written informed consent. Then the desired questionnaires are completed with the help of the researcher. FBS and HbA1c tests will be taken from patients. At the end of the session, they will receive all the recommendations related to diabetes self-care in the form of a printed file. But no interactive training such as question and answer is given to them.</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 هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehteram Sadat Ilali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibe Nursing and Midwifery School, Vesal Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3329 4601</telephone>
        <email>paradis2082000@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahab Papi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibe Nursing and Midwifery School, Vesal street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7374</telephone>
        <email>Shahabpapi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 years and above
Ability to communicate
Having a normal cognitive status based on the cognitive status assessment tool (AMT) (scoring 7 and above)
Informed consent of the patient to participate in the study
Access to a smart mobile phone and the ability to work with it
Internet access
Literacy for reading and writing
Diagnosed with diabetes by a doctor who has been diagnosed for at least 6 months</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>using care software before entering the study
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 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: After selecting the participants of the intervention group, they are invited to visit the Mustafavian diabetes clinic in Sari. In this meeting, the researcher will first introduce himself, explain the objectives of the study and obtain written informed consent. Then the desired questionnaires are completed with the help of the researcher. FBS and HbA1c tests will be taken from patients. At the end of the session, Idea software is installed for the participants of the intervention group and its performance is controlled on the phone, and with the cooperation of the patient, how to use and use it by an experienced expert (with education and experience in the field of planning and development) It will be given. If possible, it is suggested to the participants of the intervention group that a family member accompanies them in face-to-face and non-face-to-face training sessions to facilitate the process of working with Idea software. Also, along with the installed program, a pamphlet will be presented to the users, which is a guide for using the program, and it will be explained to the participants that whenever they encounter a problem during the intervention period, they can contact the researcher (a number that is available 24 hours a day). It is provided to the elderly to answer their questions. This software will allow patients to manually record diabetes self-care data (nutritional information, blood sugar records, insulin and medication records, physical activity records, emotion records) on the mobile phone, and trainings Receive information related to diabetes self-care through the software. Also, once a week, along with measuring blood sugar by the researcher, the weight of the patients will be measured using a scale and recorded in the program. The training of the participants in the intervention group will be in the form of two sessions in person and 8 sessions in person. It will be held twice a week (Mondays and Wednesdays) in the period of 15-18 on the chat page of the Idea program as a group. In this way, the educational content in the form of PDF, the recorded voice of the researcher and the educational video will be sent to the participants at 15:00 and they are requested to read the content. The researcher will have access to all the information recorded by the participants through the Idea software database and will be informed indirectly about the treatment plan and lifestyle of the patients. Also, the researcher will follow up the participants during their participation in the training sessions.</i_keyword>
      <i_keyword>Control group: After selecting the participants of the control group, they are invited to visit the Mustafavian diabetes clinic in Sari. In this meeting, the researcher will first introduce himself, explain the objectives of the study and obtain written informed consent. Then the desired questionnaires are completed with the help of the researcher. FBS and HbA1c tests will be taken from patients. At the end of the session, they will receive all the recommendations related to diabetes self-care in the form of a printed file. But no interactive training such as question and answer is given to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care score in the Summary of Diabetes Self Care Activities questionnaire. Timepoint: Measuring the self-care score at the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the intervention. Method of measurement: Summary of Diabetes Self Care Activities questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>HbA1c. Timepoint: At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the intervention. Method of measurement: It will be measured by Tobi Sari laboratory kits.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: At the beginning of the study (before the start of the intervention) and 1 and 3 months after the start of the intervention. Method of measurement: Glucometer brand DIABAN and model SMM1000 made in Iran.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-03</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Siences (Vice chanchellor for research), Moallem Square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
