<?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>IRCT20221013056162N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-02</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of educational intervention on adherence to treatment of diabetic patients.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of educational intervention based on Pender's health promotion model on the level of treatment compliance in elderly people with type 2 diabetes referring to health care centers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66319</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization and random sequence will be determined by a statistician in the form of block randomization of 4 or 6 using Excel software in the form of A, B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group. Intervention 2: Control group: The first 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:
It is possible to share the entire data.

When:
one year later.

To whom:
All people and especially researchers.

Conditions:
There are no special conditions.

Where to obtain:
Websites and my phone number. 05832248001

How to obtain:
During a written request or visiting the site.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra salehee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jannet Complex, Jannet St., Khorramshahr Square, Bojnord</address>
        <city>Bognord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9417814035</zip>
        <telephone>+98 58 3224 8001</telephone>
        <email>Saleheez1365@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Khorashadizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bojnoord School of Nursing and Midwifery, Shahriar St</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9417696786</zip>
        <telephone>+98 58 3229 7097</telephone>
        <email>khorashadizadehf891@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtain written informed consent
Age 60 and above
Diagnosing type 2 diabetes by a specialist doctor based on the patient's file and under medical treatment (pills or insulin).
At least 6 months have passed since the diagnosis of diabetes
The elderly should be able to physically attend classes.
The elderly should be aware of the person, time and place.
Persistence of diabetes
HbA1c level between 6.5 and 8.5</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal from the study
Death of the participant
Having another underlying disease
mental disorder
Patients who, for any reason, cannot attend more than 4 alternating sessions or two consecutive sessions.
Having type 1 diabetes
Not doing homework
Participation in other educational programs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>With other specified complicationsDiabetic arthropathy (M14.2*)Neuropathic diabetic arthropathy  (M14.6*).7	With multiple complications.8	With unspecified complications.9	Without complications</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: The first intervention group</i_keyword>
      <i_keyword>Control group: The first control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Medication adherence score based on Moriski questionnaire. Timepoint: Measurement of medication adherence before the start of the intervention, immediately after the last training session and three months after the last training session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Health promotion score based on Pender health promotion model questionnaire. Timepoint: The health improvement score is checked at the beginning of the study (before the start of the intervention), after the end of the last training session and three months after the end of the last training session. Method of measurement: Pender Health Promotion Questionnaire.</prim_outcome>
      <prim_outcome>Age according to birth certificate. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Gender. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Marital status. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Level of education. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Average body mass. Timepoint: The average body mass is checked at the beginning of the study (before the intervention), after the end of the last training session and three months after the end of the last training session. Method of measurement: Digital meters and scales.</prim_outcome>
      <prim_outcome>The amount of monthly income. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Place of income. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Employment status. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Living condition. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Drug treatments prescribed by the attending physician. Timepoint: The beginning of the study. Method of measurement: Demographic questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Blood pressure measurement is checked at the beginning of the study (before the intervention), after the end of the last training session and three months after the end of the last training session. Method of measurement: Mercury sphygmomanometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glycosylated blood sugar. Timepoint: At the beginning and three months after the study. Method of measurement: blood sample.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-28</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Vice President of Research and Information Technology University of Medical Sciences, next to Imam Ali Hospital, Shahryar St., Bojnord BOJNORD North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
