<?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>IRCT20220702055343N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-17</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>An investigation of the effectiveness of remote intervention monitoring signals to prevent the recurrence of disease in individuals with severe psychiatric disorders</public_title>
      <acronym></acronym>
      <scientific_title>An investigation of the effectiveness of remote intervention monitoring signals to prevent the recurrence of disease in individuals with severe psychiatric disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64611</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done in an accessible and consecutive way over time. At the beginning of the study, patients of the experimental and the control groups equalize in terms of variables such as the type and duration of the disease.
The method of selecting intervention and control group patients will be random. In this way, as the number of patients, envelopes containing a number are considered. Once the patient is selected to enter the study, the number inside one of the random envelopes indicates the patient group. An even number means the patient is in the intervention group and an odd number means the patient is in the control group.
In this way, the researcher does not know beforehand which group the patient will fall into.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Severe psychiatric diseases such as: schizophrenia, bipolar, major depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 26 patients with severe psychiatric disorders admitted to Sina Psychiatric Hospital of Juneghan who meet the criteria for entering the study. These people and their caregivers, after obtaining conscious consent from the guardian and the main caregiver and informed consent from the patient, are trained on the warning signs of relapse. After discharge, we contact the patient and their caregiver weekly, and the checklist of the patient and the family is completed regarding the status of warning signs and how to take the medicine and adhere to the treatment. Intervention 2: Control group: 26 patients with severe psychiatric disorders admitted to Sina Psychiatric Hospital of Juneghan who meet the criteria for entering the study. These people and their caregivers are placed in the control group after obtaining conscious consent from their main guardian and caregiver and informed consent from the person himself after randomization of the sealed envelope, and they are not trained, and there is no follow-up after weekly discharge.</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:
After the end of the research, the data related to the main outcome and the data related to the conscious consent of the patients and their family and the checklists will be published in the form of a master's thesis in social work.

When:
The access period is from January of 2023.

To whom:
Researchers working in university and scientific institutions and psychiatric hospitals

Conditions:
Study and use in researches

Where to obtain:
Scientific research officer

How to obtain:
The request email should be sent to the scientific officer

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Ehsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, No. 14, Alley 14, Pasdaran Street, Azadi Boulevard, Moalem Square, Shahrekord</address>
        <city>Shahr e Kord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814843615</zip>
        <telephone>+98 38 3228 8124</telephone>
        <email>moooona.Ehsani75@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Maarefvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave., Daneshjoo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 912 562 1218</telephone>
        <email>arammaref@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of severe psychiatric disorder by a psychiatrist, based on the criteria of the fifth diagnostic and statistical manual of mental diseases (DSM5), and its inclusion in the patient's medical record
conscious consent of the patient's legal guardian for them and the patient's participation in the research
conscious consent of the main caregiver of the patient in cases where the primary caregiver of the patient is someone other than their legal guardian
The psychiatric patient should be between 20 and 45 years old
The absence of mental retardation and epilepsy based on the opinion of the psychiatrist and the contents of the patient's medical record
Having at least reading and writing literacy by the person with psychiatric disease and guardian
Living in the same house with the guardian or primary caregivers (family members of the patient) participating in this research
The patient should not be a candidate for maintenance in long-term rehabilitation centers</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient or caregiver should declare their unwillingness to continue cooperation during the research.
The psychiatric patient and caregiver do not respond to the researcher's calls for three consecutive weeks.</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>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 26 patients with severe psychiatric disorders admitted to Sina Psychiatric Hospital of Juneghan who meet the criteria for entering the study. These people and their caregivers, after obtaining conscious consent from the guardian and the main caregiver and informed consent from the patient, are trained on the warning signs of relapse. After discharge, we contact the patient and their caregiver weekly, and the checklist of the patient and the family is completed regarding the status of warning signs and how to take the medicine and adhere to the treatment.</i_keyword>
      <i_keyword>Control group: 26 patients with severe psychiatric disorders admitted to Sina Psychiatric Hospital of Juneghan who meet the criteria for entering the study. These people and their caregivers are placed in the control group after obtaining conscious consent from their main guardian and caregiver and informed consent from the person himself after randomization of the sealed envelope, and they are not trained, and there is no follow-up after weekly discharge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of relapses. Timepoint: 3 months. Method of measurement: through the number of psychiatric hospital readmissions.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-16</approval_date>
        <contact_name>Ethics Committee of the University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
