<?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>IRCT20210202050222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of care program based on smartphone application for caregivers of patients with major depression</public_title>
      <acronym></acronym>
      <scientific_title>The effect of care program based on smartphone application on the burden and quality of life in family caregivers of patients with major depression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61137</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random sequence was prepared before the study by the simple block method. There are  7 blocks with 10 samples. The sequence of each block is determined based on SPSS software. Each block is in a sealed envelope and the researcher does not know its sequence.</study_design>
      <phase>N/A</phase>
      <hc_freetext>major Depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group includes family caregivers of depressed patients who are discharging their patients. The application will be installed in a 30-minute session for caregivers and then explanations for using the application will be given to caregivers, and once a week after installing the application, contact the caregivers. The ability and efficiency of the application will be examined and possible questions will be answered. If there are problems such as the inability to use the application and problems with the operating system and its structure, the researcher will try to solve them. Application content includes patient nutrition and diet, medication diet, sleep and rest, activity and exercise, recognizing the disease and its symptoms, behavioral strategies to improve relationships with the patient, shock therapy and care, treatment follow-up, and periodic monitoring. The Fortinash Psychiatric Nursing Care Plans, the American Depression and Anxiety Association, and the British Columbia-Canada Mood Disorders Association book were used to collect the necessary points and were narrated by three Nursing School professors and a psychiatrist and psychiatrist. After the narration, it has become a mobile application. This application is an educational type that includes text, photos, and videos about the mentioned care topics. In addition, the possibility of communicating with the nurse in the form of chat has been included in the application in order to answer their questions privately. Intervention 2: Control group: The control group is under routine training that has been provided by health workers (nurses, doctors, etc.) at the time of discharge. At Ibn Sina Hospital in Mashhad, due to the limitations of following a corona pandemic, family education about patient care is provided only at the time of discharge. During discharge, a nurse instructs the patient in a 10 to 15 minute session on the patient's subsequent monitoring and how to take medications according to the physician's instructions using a face-to-face method and the use of pamphlets.</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 of the caregivers' demographic information can be shared after identifying individuals. All of the quality of life and burden assessment information can be shared with caregivers after unidentified individuals.

When:
After publishing the article

To whom:
Project partners

Conditions:
People who do similar research

Where to obtain:
It will be done by email with the person in charge of the project.

How to obtain:
Data is made available to individuals via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somaye Minaeimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>sminaei.moghadam95@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Vaghei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>vaghees@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 60
With a diagnosis of at least 6 months of  major depression
Lack of physical disability leading to activity limitation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of illness associated with depression such as anxiety disorder
Existence of mania episode</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 group includes family caregivers of depressed patients who are discharging their patients. The application will be installed in a 30-minute session for caregivers and then explanations for using the application will be given to caregivers, and once a week after installing the application, contact the caregivers. The ability and efficiency of the application will be examined and possible questions will be answered. If there are problems such as the inability to use the application and problems with the operating system and its structure, the researcher will try to solve them. Application content includes patient nutrition and diet, medication diet, sleep and rest, activity and exercise, recognizing the disease and its symptoms, behavioral strategies to improve relationships with the patient, shock therapy and care, treatment follow-up, and periodic monitoring. The Fortinash Psychiatric Nursing Care Plans, the American Depression and Anxiety Association, and the British Columbia-Canada Mood Disorders Association book were used to collect the necessary points and were narrated by three Nursing School professors and a psychiatrist and psychiatrist. After the narration, it has become a mobile application. This application is an educational type that includes text, photos, and videos about the mentioned care topics. In addition, the possibility of communicating with the nurse in the form of chat has been included in the application in order to answer their questions privately.</i_keyword>
      <i_keyword>Control group: The control group is under routine training that has been provided by health workers (nurses, doctors, etc.) at the time of discharge. At Ibn Sina Hospital in Mashhad, due to the limitations of following a corona pandemic, family education about patient care is provided only at the time of discharge. During discharge, a nurse instructs the patient in a 10 to 15 minute session on the patient's subsequent monitoring and how to take medications according to the physician's instructions using a face-to-face method and the use of pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Burden. Timepoint: At the beginning of the study (before the intervention) and immediately after the intervention. Method of measurement: caregivers burden inventory-CBI.</prim_outcome>
      <prim_outcome>QUALITY OF LIFE. Timepoint: At the beginning of the study (before the intervention) and immediately after the intervention. Method of measurement: WHOQOL-BREF questioner.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-09</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Ibn Sina St.University St. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
