<?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>IRCT20181210041915N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Group Reality Therapy on adherence to the therapeutic regimen and improvement of health indicators in Diabetes patient</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of group reality therapy with a routine education program on adherence to the therapeutic regimen and improvement of health indicators in patients with Diabetes Type 2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 patients referred to Amir Almonin Hospital in Ahvaz patients were selected based on inclusion criteria. Then they were allocated into two groups of 30 people (intervention group and the control group) by a coin randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The treatment protocol of the intervention group consisted of 10 sessions of 45 minutes (one session per week) for 2 months in the form of lectures and face-to-face training for the intervention group. Topics discussed in these sessions include information about diabetes, its causes and factors, how to take care of yourself, blood sugar control strategies, psychological support such as stress, anxiety, etc., strengthening positive thinking and ways Success, examining how to live better, etc. During each session, the topics and discussions of the previous sessions were also examined. The program of group reality therapy training sessions was based on the latest articles and books and consultations with experts based on Glaser's theory of choice and the theory of confrontation with the theory and was presented by the researcher with the help of the researcher (clinical psychologist). Then, the educational materials were provided to both groups in the form of educational booklets and CDs after the study. At the end of the training sessions, the intervention group was given the opportunity to apply new skills in their daily lives, during which the researcher contacted them by telephone and was given a telephone number to If necessary, call and raise their problems. Intervention 2: Control group: In the control group, routine care include patient education, lab checkup that provided by the Diabetes Control Center of Amir-Almomenin hospital was used.</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:
Some sections of data if can not be identified I can provide to whom may use scientific purposes.

When:
6months later

To whom:
Scientific institutions

Conditions:
No other one

Where to obtain:
Ahvaz Jundishapur University of medical sciences

How to obtain:
the informed request should be signed

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>kourosh zarea</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur university of medical sciences&lt; Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8764568981</zip>
        <telephone>+98 61 3373 8621</telephone>
        <email>zarea_k@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>kourosh zarea</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur university of medical sciences&lt; Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8764568981</zip>
        <telephone>+98 61 3373 8621</telephone>
        <email>zarea_k@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having minimum literacy skills
Not working, spouse or first-degree relatives in health centers
Willingness to participate in the study
At least two months have passed since diagnosis of diabetes
Not having a history of uncontrolled underlying diseases such as epilepsy
The patient has never received any training in the field of reality therapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not participating in more than one training session
Psychiatric treatments or the use of psychotropic drugs and substance abuse during study</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The treatment protocol of the intervention group consisted of 10 sessions of 45 minutes (one session per week) for 2 months in the form of lectures and face-to-face training for the intervention group. Topics discussed in these sessions include information about diabetes, its causes and factors, how to take care of yourself, blood sugar control strategies, psychological support such as stress, anxiety, etc., strengthening positive thinking and ways Success, examining how to live better, etc. During each session, the topics and discussions of the previous sessions were also examined. The program of group reality therapy training sessions was based on the latest articles and books and consultations with experts based on Glaser's theory of choice and the theory of confrontation with the theory and was presented by the researcher with the help of the researcher (clinical psychologist). Then, the educational materials were provided to both groups in the form of educational booklets and CDs after the study. At the end of the training sessions, the intervention group was given the opportunity to apply new skills in their daily lives, during which the researcher contacted them by telephone and was given a telephone number to If necessary, call and raise their problems.</i_keyword>
      <i_keyword>Control group: In the control group, routine care include patient education, lab checkup that provided by the Diabetes Control Center of Amir-Almomenin hospital was used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of adherence to therapeutic regime based on questionnaire of adherence to therapeutic regime in patients with diabetes. Timepoint: The measurement of adherence to therapeutic regime was measured before the study, 1  and 2 months after the start of the group reality therapy. Method of measurement: Questionnaire of adherence to therapeutic regime in patients with diabetes.</prim_outcome>
      <prim_outcome>Primary variable was cholesterol levels. Timepoint: The measurement of blood cholesterol level before the study, 1 and 2 months after the start of group reality therapy. Method of measurement: Cholesterol level detection kit in the laboratory.</prim_outcome>
      <prim_outcome>Primary variable was Blood Gloucester Hemoglobin( HBA1C) levels. Timepoint: level of Blood Gloucester Hemoglobin (A1C Hb) before the study, 1 and 2 months after the start of the group reality therapy was measured. Method of measurement: The HbA1C hemoglobin measurement kit in the laboratory was used.</prim_outcome>
      <prim_outcome>Fasting Blood Sugar level. Timepoint: level of Fasting Blood Sugar before of the study, 1 and 2 months after the start of the group reality therapy was measured. Method of measurement: The Fasting Blood Sugar measurement kit in the laboratory.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ahvaz jundishapur university of medical sciences</contact_name>
        <contact_address>Ahvaz Jundishapur university of medical sciences&lt; Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
