<?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>IRCT20221011056146N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-18</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effect of Self-management Education in Teach Back Method on Medication and Nutritional Adherence of Elderly Patients with Type 2 Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Self-management Education in Teach Back Method on Medication and Nutritional Adherence of Elderly Patients with Type 2 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66903</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The patients who met the conditions for entering the study were divided into two intervention and control groups according to the random number table.
We will try to select patients as much as possible, until two groups are homogeneous in terms of age, sex, education and other variables.
to be selected and also to check the homogeneity of the demographic variables in the two training and control groups, from the detailed test.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group In this group, the content is presented in the form of feedback training, where the trainer, who is a researcher himself, is responsible for the training; content in simple and understandable language; without using specific medical terms, he teaches the client individually and after the end of the training, he asks the client to understand the content; to tell in his own language; If the client has not understood and narrated the content well; person teaching until full understanding; He will repeat the contents for the client. Number of sessions: 6 sessions, twice a week, each session is 20 minutes, which will be completed within 3 weeks. Session topics: diabetes, drug therapy in diabetes, diet in diabetes. Exercise activity in diabetes. Blood sugar measurement methods. The effect of stress on diabetes. Intervention 2: Control group: Control group: teacher, subjects: diabetes, drug therapy in diabetes, diet in diabetes. Exercise activity in diabetes. Blood sugar measurement methods. The effect of stress on diabetes. The number of sessions is 6 sessions, twice a week, each session is 20 minutes, which will be completed within 3 weeks.</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 Due to the confidentiality of participants' information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsaneh Garshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Shahriar Street</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9418636595</zip>
        <telephone>+98 58 3272 4459</telephone>
        <email>Garshsad@NKUMS.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Garshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Shahriar Street</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9418636595</zip>
        <telephone>+98 58 3272 4459</telephone>
        <email>Garshsad@NKUMS.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Having type 2 diabetes, at least one year has passed since the definitive diagnosis of the disease by a doctor
Not having visual problems (able to read the line of a magazine or newspaper from a distance of 30 cm)
Not having movement problems and having minimal reading and writing literacy and not suffering from severe and debilitating complicationsCaused by diabetes such as kidney failure and...
able to speak and communicate; Absence of cognitive problems
Random allocation: At first, the patients who met the criteria for entering the study were divided into two intervention and control groups according to the table of random numbers(even odd)
Exclusion: variables that could not be controlled and could have a strong effect on the research resultswere included in the entry and exit criteria.
Consideration and homogenization: variables that cannot be eliminated, with the help of statistical testsChi-square, Fisher, independent t, will be analyzed and homogenized. These variablesThey include: level of education, income, marital status, insurance status and use of other drugs.Community Verified icon
No cognitive problems</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue cooperation in the study
Failure to participate in even one training session
Participation in similar training sessions
Having education in the field of medical sciences</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E16.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes</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 In this group, the content is presented in the form of feedback training, where the trainer, who is a researcher himself, is responsible for the training; content in simple and understandable language; without using specific medical terms, he teaches the client individually and after the end of the training, he asks the client to understand the content; to tell in his own language; If the client has not understood and narrated the content well; person teaching until full understanding; He will repeat the contents for the client. Number of sessions: 6 sessions, twice a week, each session is 20 minutes, which will be completed within 3 weeks. Session topics: diabetes, drug therapy in diabetes, diet in diabetes. Exercise activity in diabetes. Blood sugar measurement methods. The effect of stress on diabetes</i_keyword>
      <i_keyword>Control group: Control group: teacher, subjects: diabetes, drug therapy in diabetes, diet in diabetes. Exercise activity in diabetes. Blood sugar measurement methods. The effect of stress on diabetes. The number of sessions is 6 sessions, twice a week, each session is 20 minutes, which will be completed within 3 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Return training. Timepoint: Food compliance. Method of measurement: Medication compliance.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Medication compliance. Timepoint: Before training and six sessions after training. Method of measurement: Questionnaires for demographic information, Moriski medication adherence questionnaire for the elderly in both groups of return education and education in the usual way.</sec_outcome>
      <sec_outcome>Food compliance. Timepoint: Before training and six sessions after training. Method of measurement: Questionnaire of demographic information, dietary compliance questionnaire (Mediterranean diet adherence tool) for the elderly in both groups of return education and education in the usual way.</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>2020-01-05</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Shahyar St Boujnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
