<?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>IRCT20190806044449N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-19</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of web-based educational intervention on self-management in type  diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of web-based education on self-management and HbA1C in type 2 diabetic patients, discharged from Alzahra hospital in Isfahan in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The subjects who were registered in the statistics office of Al-Zahra Health Education Office in 1398-99 will be selected in the initial list, then we will telephone call and explain the objectives of the study units with the main caregiver (support person). after that, The units will invitations and informed consent form and pre-test questionnaire and completed then they will be divided into two groups of test and control using randomization software (Random Allocation Software Version 1.0, May 2004), Blinding description: The consent form is obtained from all selected individuals and then randomly divided into two groups of control and test. The control group will receive the usual training and the test group will receive the training based on the web-based teaching method. Therefore, all participants in this study are blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, at first, a how-to-use website guidance pamphlet and a card containing username and password to login the website will be given. in the next step, patients could watch the Health Promotion Model constructs-based training course on the website in a two week period. In addition, at the end of the training program up to 3 months after, will receive reminder messages to encourage us to view the educational content uploaded on the website once a week via SMS Evaluating will be done through the questionnaire before the intervention, two weeks and 3 months after the intervention. Control group: the control group patients receive routine training in the ward. Evaluating will be done through questionnaires before the intervention, two weeks, and 3 months after the end of the intervention. After doing the final measurement, participants in the control group will receive a Website`s pamphlet guidance and a card containing username and password to view educational content. Intervention 2: Control group: 'In this group, after the initial assessment of blood sugar and evaluation through a questionnaire (routine hospital training will be done), they are asked to return again in the next three weeks.A  telephone call will be made to call the participating units for the second test and three months later for the final test and HbA1C test. After the last measurement, the participants of the control group will receive a training guide for using the website and a card containing the password and username to receive the training content.</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:
Results from demographic data, questionnaires and blood tests can be shared anonymously.
The study protocol will be announced.

When:
Start access period after printing results

To whom:
According to the research title, all interested people will have access to the results.

Conditions:
The results will be published in scientific journals and in addition ; the researchers' emails will be available

Where to obtain:
The way to communicate is emales.
shahshahani@nm.mui.ac.ir
eghtedari.dl@gmail.com

How to obtain:
It will be answered at least 1 week after request.

Comments:
Only the results and study protocol will be presented.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Eghtedari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Health, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Azadi Square, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673465</zip>
        <telephone>+98 31 3620 2008</telephone>
        <email>eghtedari.dl@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryamsadat Shahshahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673465</zip>
        <telephone>+98 31 3792 7585</telephone>
        <email>shahshahani@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>Patients should be type 2 diabetics diagnosed at least one year before the research according to a physician.
They should be Persian.
The patient and his/her primary caregiver should be able to use the smart phone and have the application installed.
They should have attended at least one session in the patient education program at Al-Zahra Hospital.
Have an interest and informed consent to participate in the program.
Having a glucometer at home.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosed with type 1 diabetes
Experiencing chronic and advanced diabetes complications such as: nephropathy, proliferative retinopathy, amputation
Mental retardation, or diagnosis of psychological disorders before diabetes diagnosis or having a severe psychological disorder after diabetes diagnosis
Patients with long-term diabetes and no caregivers.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, at first, a how-to-use website guidance pamphlet and a card containing username and password to login the website will be given. in the next step, patients could watch the Health Promotion Model constructs-based training course on the website in a two week period. In addition, at the end of the training program up to 3 months after, will receive reminder messages to encourage us to view the educational content uploaded on the website once a week via SMS Evaluating will be done through the questionnaire before the intervention, two weeks and 3 months after the intervention. Control group: the control group patients receive routine training in the ward. Evaluating will be done through questionnaires before the intervention, two weeks, and 3 months after the end of the intervention. After doing the final measurement, participants in the control group will receive a Website`s pamphlet guidance and a card containing username and password to view educational content</i_keyword>
      <i_keyword>Control group: 'In this group, after the initial assessment of blood sugar and evaluation through a questionnaire (routine hospital training will be done), they are asked to return again in the next three weeks.A  telephone call will be made to call the participating units for the second test and three months later for the final test and HbA1C test. After the last measurement, the participants of the control group will receive a training guide for using the website and a card containing the password and username to receive the training content.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self management of diabetes. Timepoint: Completion of the questionnaire at baseline (before intervention), 21 days later and three months later. Method of measurement: Schmidt et al. Diabetes self-management questionnaire.</prim_outcome>
      <prim_outcome>HbA1C changes. Timepoint: HbA1C measurement. Method of measurement: HPLC method and Siba electro-foresight 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>2019-11-13</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave., Azadi Square Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
