<?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>IRCT20140212016564N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-12</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of home nursing care on the quality of life in patient with major depression referring to educational-trearment Razi psychiatric center of Urmia in 2019-2020</public_title>
      <acronym></acronym>
      <scientific_title>The effect of home nursing care on the quality of life in patient with major depression referring to educational-trearment Razi psychiatric center of Urmia in 2019-2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50121</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Using the available sampling method and taking into account the drop in samples, 50 people with inclusion criteria were selected and randomly selected in the stages of preparation for discharge of patients who have a diagnosis of major depression in the file by selecting one of the two cards containing the group content. The intervention or control group is divided into two groups) will be divided into two groups of intervention and control. Thus, each of the intervention groups will have 25 people and the control group will have 25 people. The control group will not receive home nursing care. The groups will fit together and there will be the same number of people receiving ECT in both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>major depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Home nursing care Implementation of home care program for the intervention group in 5 to 6 sessions once every two weeks for 1.5 to 2 hours for 3 months depending on the needs of patients and telephone follow-up program in the first month After discharge 3 times a week, in the second month 2 times a week and in the third month after discharge once a week.The care provided by the researcher includes client assessment, scheduling that includes counseling and training programs, and intervention programs. In educational programs, education is provided to the patient and family on how to use drugs and side effects, communication skills, social skills, self-care and help to better understand the disease and existing treatments. They will be face to face and orally. Intervention 2: Control group: They do not receive any intervention.</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:
Documentation will be published in the form of an article. All demographic characteristics such as age, sex, level of education, job position, suicide, receiving ECT can be published. Also, the quality of life in people can be published

When:
Access starts 3 months after the results are published

To whom:
Available to all researchers in the field of psychiatry

Conditions:
Compare demographic characteristics with quality of life or two groups with each other

Where to obtain:
Radfar: Associate Professor Mradfar1343@gmail.com
Mahsa Koohi: Master of Urmia University of Medical Sciences mahsa2144@gmail.com-09382892144
Leila Aliloo: Assistant Professor Urmia University of Medical Sciences aliluleiyla@gmail.com

How to obtain:
Send e-mail and in case of no response after one day by phone and coordination with research members and if you agree to provide information for about a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Molood Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khoy Imam Hossein Square Shams Tabrizi dead end</address>
        <city>Khoy Imam Hossein Square Shams Tabrizi dead end</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5818736461</zip>
        <telephone>+98 44 3366 9694</telephone>
        <email>mahsa2144@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Molood Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khoy Imam Hossein Square Shams Tabrizi dead end</address>
        <city>Khoy</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5818736461</zip>
        <telephone>+98 44 3366 9694</telephone>
        <email>mahsa2144@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of major depression recorded in the file
Willingness to cooperate
Lack of mental retardation
Able to speak Persian or Turkish
No drug addiction except smoking
Lack of residence in accommodation covered by welfare
Age between 18-60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of patient consent to continue treatment
Long-distance travel and transfer to another city
Exacerbation of the disease and hospitalization</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mood disorder due to known physiological condition</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: Home nursing care Implementation of home care program for the intervention group in 5 to 6 sessions once every two weeks for 1.5 to 2 hours for 3 months depending on the needs of patients and telephone follow-up program in the first month After discharge 3 times a week, in the second month 2 times a week and in the third month after discharge once a week.The care provided by the researcher includes client assessment, scheduling that includes counseling and training programs, and intervention programs. In educational programs, education is provided to the patient and family on how to use drugs and side effects, communication skills, social skills, self-care and help to better understand the disease and existing treatments. They will be face to face and orally.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and 3 months later and 6 months after. Method of measurement: Quality of life score in MC GILL questionnaire.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-07</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Khoy Imam Hossein Square Shams Tabrizi dead end KHOY West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
