<?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>IRCT20210109049978N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Internet- Based Psychoeducational Support on Perceived Stress and Caring Burden in Caregivers of Patients with COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Internet- Based Psychoeducational Support on Perceived Stress and Caring Burden in Caregivers of Patients with COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53594</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 24. According to the sample size of 70 in the present study, 18 quadruple blocks will be considered. Each caregiver will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, 6 sessions of 35 to 45 minutes per day will be held in the form of group video call (webinar) which will be held in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the field of education: (Introduction of Covid-19, personal protective equipment, providing care for patient with COVID-19 at home after discharge, nutrition management during COVID-19 crisis, providing care for the elderly, children during the COVID-19 crisis, principles of infection control and Disinfection, warning signs of the disease in those around and the patient in the recovery period, the patient taking medications) and in the psychological field of stress management program according to the theoretical model of stress management Lazarus and Folkman (1- Stress education and its effective factors 2- Supporting caregivers in identifying Stressful dysfunctional thoughts 3- Providing coping strategies (problem-oriented and emotion-oriented) to deal with stress 4- Providing support in applying the support provided in daily life and patient care). Data collection tools included demographic information form, Cohen Standard Perceived Stress Questionnaire (PSS-14) and Zarit Burden Inventory Questionnaire (ZBI) which on the first day after discharge, before the first session in the intervention group by all caregivers ( Intervention and Control Group) will be completed online. After 14 days of completing the questionnaires, the mentioned questionnaires will be completed to measure the effectiveness of the intervention on the web. Intervention 2: Control group: They use the routine education of the medical center. Supporting contents will be provided to the control group after the 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:
Some of the caregivers' demographic information can be shared after unidentifying individuals. All of the perceived stress and caring burden assessment information can be shared with caregivers after unidentified individuals.

When:
After publishing the article and defending the dissertation

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>Saeed Vaghee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ibn Sina St.University St.</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>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Vaghee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ibn Sina St.University St.</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>Caregiver age between 18-60.
No psychological disorders in the caregiver.
No drug addiction in the caregiver.
No hearing or vision impairment in the caregiver.
The caregiver should have the most contact with the patient in the post-discharge period.
Ability to access the Internet and online mass communication software.
Have the minimum ability to use smartphones and social networks.
Non-participation in other supportive interventions in the case of Covid-19.
The caregiver should not be a member of the health care system (such as doctors, nurses, midwives, etc.).
The caregiver is a family member of the patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Do not participate in the post-test.
Absence from more than two sessions in support sessions.
The reluctance of caregiver in participate in the sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus not identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group, 6 sessions of 35 to 45 minutes per day will be held in the form of group video call (webinar) which will be held in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the field of education: (Introduction of Covid-19, personal protective equipment, providing care for patient with COVID-19 at home after discharge, nutrition management during COVID-19 crisis, providing care for the elderly, children during the COVID-19 crisis, principles of infection control and Disinfection, warning signs of the disease in those around and the patient in the recovery period, the patient taking medications) and in the psychological field of stress management program according to the theoretical model of stress management Lazarus and Folkman (1- Stress education and its effective factors 2- Supporting caregivers in identifying Stressful dysfunctional thoughts 3- Providing coping strategies (problem-oriented and emotion-oriented) to deal with stress 4- Providing support in applying the support provided in daily life and patient care). Data collection tools included demographic information form, Cohen Standard Perceived Stress Questionnaire (PSS-14) and Zarit Burden Inventory Questionnaire (ZBI) which on the first day after discharge, before the first session in the intervention group by all caregivers ( Intervention and Control Group) will be completed online. After 14 days of completing the questionnaires, the mentioned questionnaires will be completed to measure the effectiveness of the intervention on the web.</i_keyword>
      <i_keyword>Control group: They use the routine education of the medical center. Supporting contents will be provided to the control group after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress. Timepoint: At the beginning of the study (before the intervention) and 14 days later. Method of measurement: Cohen Perceived Stress Scale.</prim_outcome>
      <prim_outcome>Caring Burden. Timepoint: At the beginning of the study (before the intervention) and 14 days later. Method of measurement: Zarit Burden 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-06</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>
