<?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>IRCT20200504047296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of family - centered care based on Newman's systemic model on the quality of life in patients with diabetes type 2</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family- centered care based on Newman's systemic model on the quality of life in patients with diabetes type 2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68297</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the first stage, sampling is done in a purpose-based manner, and the eligible samples are selected based on the study entry criteria, then they are randomly assigned to two test and control groups by block method with blocks of 4 people. The simple random method causes the inequality of people in two groups, which reduces the statistical power of the test used. Therefore, by using the block method with random allocation, the people assigned to two groups are equal to each other. To avoid predicting the allocation of people in the group, blocks of different sizes (blocks of 4 people and 6 people) are determined. Then, by entering the information of the number of blocks, groups and total samples to reliable sites such as "https://www.sealedenvelope.com/simple-randomiser/v1/lists", the order of people is assigned to groups, similar to the information below. be.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in this study includes teaching the diet plan of diabetics - teaching the general principles of diabetic foot care - teaching prevention methods - giving awareness and information about the disease - allowing the patient to express his feelings - regular blood sugar control - exercising the feet - Daily walk, regular use of diabetic medication - Regular examination of the skin of the limbs - Recommendation for regular examination by an ophthalmologist - Regular blood sugar control - Training on warning signs and prevention methods - Regular blood pressure control - Training on diet plan for diabetic patients - Previous blood sugar control Sleep-recommendation to exercise before going to sleep-not consuming caffeinated substances before going to sleep-providing a calm environment for sleeping-teaching the patient about the disease and how to control and prevent complications in the form of face-to-face meetings and preparation of educational pamphlets. The sessions are tailored to the educational needs of the patients and are at least 6 sessions of 30 minutes. A meeting will be held every week. The nursing diagnoses related to each patient will be determined based on the completion of the Newman evaluation form by the participating members of the intervention group, and the care plan will be designed and implemented based on the nursing process. that nursing diagnoses based on Nanda Nursing Diagnosis (Nursing Diagnosis Institute of North America) along with related nursing care will be implemented for each patient privately. Intervention 2: Control group: The control group will only complete the quality of life questionnaire and demographic characteristics. The duration of the intervention lasts a maximum of 2 months, and one month after the end of the intervention, the quality of life questionnaire will be completed again.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>SOMAYERAHIMI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Street, Central Building, Esfrain Faculty of Medical Sciences</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661876981</zip>
        <telephone>+98 58 3722 3504</telephone>
        <email>SOMAYERAHIMI90@GMAIL.COM</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>SOMAYE RAHIMI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Street - Esfrain Faculty of Medical Sciences</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661876981</zip>
        <telephone>+98 58 3722 3504</telephone>
        <email>SOMAYERAHIMI90@GMAIL.COM</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient's condition: diagnosis of type 2 diabetes according to internal specialist's opinion
Having a history of type 2 diabetes for more than one year
The patient's ability to understand and speak Persian
Conditions of one of the patient's family members: having literacy to read and write
Willingness to participate in patient accompanying meetings
Hearing the patient's words from him
Living with the patient</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>In the critical phase of the disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with unspecified complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in this study includes teaching the diet plan of diabetics - teaching the general principles of diabetic foot care - teaching prevention methods - giving awareness and information about the disease - allowing the patient to express his feelings - regular blood sugar control - exercising the feet - Daily walk, regular use of diabetic medication - Regular examination of the skin of the limbs - Recommendation for regular examination by an ophthalmologist - Regular blood sugar control - Training on warning signs and prevention methods - Regular blood pressure control - Training on diet plan for diabetic patients - Previous blood sugar control Sleep-recommendation to exercise before going to sleep-not consuming caffeinated substances before going to sleep-providing a calm environment for sleeping-teaching the patient about the disease and how to control and prevent complications in the form of face-to-face meetings and preparation of educational pamphlets. The sessions are tailored to the educational needs of the patients and are at least 6 sessions of 30 minutes. A meeting will be held every week. The nursing diagnoses related to each patient will be determined based on the completion of the Newman evaluation form by the participating members of the intervention group, and the care plan will be designed and implemented based on the nursing process. that nursing diagnoses based on Nanda Nursing Diagnosis (Nursing Diagnosis Institute of North America) along with related nursing care will be implemented for each patient privately.</i_keyword>
      <i_keyword>Control group: The control group will only complete the quality of life questionnaire and demographic characteristics. The duration of the intervention lasts a maximum of 2 months, and one month after the end of the intervention, the quality of life questionnaire will be completed again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: Summarized clinical questionnaire of the quality of life of diabetic patients.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-17</approval_date>
        <contact_name>Ethics committee of Islamic Azad Isfahan (Khorasgan) Branch  University of Medical Sciences</contact_name>
        <contact_address>East J St.-Arghavanieh-- University Blvd Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
