<?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>IRCT20211228053558N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-17</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Pender's health promotion model on medication adherence of type 2 diabetes patients</public_title>
      <acronym></acronym>
      <scientific_title>Design, implementation and evaluation of an intervention based on the Pender health promotion model to improve the medication adherence of type 2 diabetes patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>166</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study is performed in three phases: qualitative, cross-sectional and intervention, and the effect can be measured through a questionnaire and a1c test, Randomization description: Eligible samples are selected through systematic random sampling from Hormoz Diabetes Clinic (Bandar Abbas Diabetes Reference Clinic). Based on the information recorded in the center files (taking into account the inclusion criteria) to achieve the required sample size of 83 people in the intervention group and 83 control people, individuals through systematic random sampling from the list using sampling distance ( k), [k = N / n (1500 ÷ 166 = 9)] will be selected. From 1 to 9, a number will be randomly selected as the first sample and then the second sample will be selected by adding the number 9 to the first patient and this process will continue until the end. After identifying the samples, a lottery will be drawn between the two intervention and control groups. The first lottery will be called the intervention group and then the next names will be placed one by one in the control and intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Hormoz Diabetes Clinic of Shahid Mohammadi Hospital in Bandar Abbas as the place of intervention and using educational services will be 10-12 sessions in person or online or a combination of both depending on the university conditions during the Covid-19 epidemic. The use of educational clips, posters and pamphlets will be in the training process and the main content of the sessions on promoting and improving adherence to treatment in the areas of drug therapy, physical activity and nutrition (content according to Pender's health promotion model to promote self-efficacy, related emotions By adhering to and reducing benefits, etc.) it will be that face-to-face meetings will be set with an average time of 45 minutes and online meetings of 15 minutes. The control group will not receive training and will receive the clinic's routine care services. Then the changes in the results of the hemoglobin A1C test in both groups will be examined. Intervention 2: Control group: does not receive any intervention and uses the normal services of the clinic.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Shahabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bandar Abbas, Jomhuri Eslami Blvd., Bustan Alley 10, Faculty of Health</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919916753</zip>
        <telephone>+98 76 3333 8583</telephone>
        <email>nahid.shahabi@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Shahabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bandar Abbas, Jomhuri Eslami Blvd., Bustan Alley 10, Faculty of Health</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919916753</zip>
        <telephone>+98 76 3333 8583</telephone>
        <email>nahid.shahabi@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in research
Registration of a case in the diabetes clinic of Shahid Mohammadi hospital as a type 2 diabetic patient
Living in Bandar Abbas</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not participating in regular training sessions (absence of more than 2 sessions)
Not going to the diabetes clinic of Shahid Mohammadi Hospital</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Hormoz Diabetes Clinic of Shahid Mohammadi Hospital in Bandar Abbas as the place of intervention and using educational services will be 10-12 sessions in person or online or a combination of both depending on the university conditions during the Covid-19 epidemic. The use of educational clips, posters and pamphlets will be in the training process and the main content of the sessions on promoting and improving adherence to treatment in the areas of drug therapy, physical activity and nutrition (content according to Pender's health promotion model to promote self-efficacy, related emotions By adhering to and reducing benefits, etc.) it will be that face-to-face meetings will be set with an average time of 45 minutes and online meetings of 15 minutes. The control group will not receive training and will receive the clinic's routine care services. Then the changes in the results of the hemoglobin A1C test in both groups will be examined.</i_keyword>
      <i_keyword>Control group: does not receive any intervention and uses the normal services of the clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Medication adherence score. Timepoint: At the beginning of the study and 3 months after the intervention. Method of measurement: medication adherence questionnaire.</prim_outcome>
      <prim_outcome>Hemoglobin A1C test. Timepoint: At the beginning of the study (before the intervention) and 3 months after the end of the intervention. Method of measurement: The hemoglobin A1C listed in the test result.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-22</approval_date>
        <contact_name>Ethics committee of hormozgan University of Medical Sciences</contact_name>
        <contact_address>Iran, Hormozgan, Bandar Abbas, Shahid Chamran Boulevard bandarabbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
