<?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>IRCT20231107059976N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-29</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of early palliative care on quality of life and self-care behaviours in patient with type2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of early palliative care on quality of life and self-care behaviours in patient with type2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74031</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Random allocation law is used to allocate two groups. First, the sample size is determined, which becomes 100, then each sample is assigned a number from 1 to 100, and each number is recorded on paper and thrown into a lottery container, and group A is the test group and group B is the group Control is considered. Each paper is taken randomly and without replacement and placed in group A and then B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention is held 4 sessions weekly, the first 2 sessions are in groups, people are divided into 5 groups of 10 people, and group training sessions will be held between 60 and 90 minutes, after the training, there will be time to answer the clients' questions and group discussion. Taken. Thus, in the first session, the concept of diabetes and its symptoms, consequences and risks, the concept of palliative care and palliative care in diabetes are discussed. In the second session, the control of symptoms in the field of diet, medication, exercise and movement will be discussed and the needs of people in these areas will be examined. . In the third session, symptom management will be discussed regarding symptom control, relaxation methods, nutritional recommendations, foot care, and the consequences of diabetes. The third and fourth session will be held individually, the fourth session will be about examining the patient's values ​​and helping to make decisions about treatment and symptom control, and the care plan will be based on the needs of the client and his participation, with special attention to the symptoms. physical and psychosocial are regulated and the goals of care are determined, In the fifth session, the general review of life will be done by the researcher through the client's participation, and his needs will be determined in terms of improving the level of life in different areas. Then for 5 weeks follow-up will be done by the researcher to answer the questions and check the adherence to the care plan through text message or phone call. Intervention 2: Control group: Routine care is received during the study and After completing the study, the training files will be provided to the 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:
Only part of the data related to the main outcomes of the study

When:
The access period starts six months after the publication of the results

To whom:
Researchers working in academic institutions

Conditions:
For scientific use for studies

Where to obtain:
Gholizade.zahra.1278@gmail.com

How to obtain:
Send a letter with the title of study data request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Gholizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golha street</address>
        <city>Shahrud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3615819413</zip>
        <telephone>+98 23 3220 3966</telephone>
        <email>gholizade.zahra.1278@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Gholizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golha</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3615819413</zip>
        <telephone>+98 23 3220 3966</telephone>
        <email>gholizade.zahra.1278@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of type 2 diabetes
Access and ability to use mobile phones
Ability to communicate in Farsi
Access to internet</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-cooperation during intervention
Suffering from other life-threatening chronic diseases such as cancer, heart failure, etc
Partially deaf
Cognitive and mental disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(E10-E14)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention is held 4 sessions weekly, the first 2 sessions are in groups, people are divided into 5 groups of 10 people, and group training sessions will be held between 60 and 90 minutes, after the training, there will be time to answer the clients' questions and group discussion. Taken. Thus, in the first session, the concept of diabetes and its symptoms, consequences and risks, the concept of palliative care and palliative care in diabetes are discussed. In the second session, the control of symptoms in the field of diet, medication, exercise and movement will be discussed and the needs of people in these areas will be examined. . In the third session, symptom management will be discussed regarding symptom control, relaxation methods, nutritional recommendations, foot care, and the consequences of diabetes. The third and fourth session will be held individually, the fourth session will be about examining the patient's values ​​and helping to make decisions about treatment and symptom control, and the care plan will be based on the needs of the client and his participation, with special attention to the symptoms. physical and psychosocial are regulated and the goals of care are determined, In the fifth session, the general review of life will be done by the researcher through the client's participation, and his needs will be determined in terms of improving the level of life in different areas. Then for 5 weeks follow-up will be done by the researcher to answer the questions and check the adherence to the care plan through text message or phone call.</i_keyword>
      <i_keyword>Control group: Routine care is received during the study and After completing the study, the training files will be provided to the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score with Quality of life questionnaire for patients with diabetes. Timepoint: At the beginning of the study and 5 weeks after the end of the study. Method of measurement: Quality of life questionnaire for patients with diabetes.</prim_outcome>
      <prim_outcome>The score of Self-care behaviors with the questionnaire of self-care behaviors of patients with diabetes. Timepoint: At the beginning of the study and 5 weeks after the end of the study. Method of measurement: Questionnaire of self-care behaviors of patients with diabetes.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-05</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Nosrat St., Tohid Sq. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
