<?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>IRCT20210111050011N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-16</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With Covid-19</public_title>
      <acronym>Covid-19</acronym>
      <scientific_title>The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With Covid-19 After Discharge From Hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples will be selected by available methods and will be randomly assigned to intervention and control groups using random allocation blocks. R Software will be used to get the blocks. The blocks are made up of 4 English letters (A,B,C,D). A , and B will be considered for the intervention group, and other two letters (C, and D) will be considered for the control group. The blocks will be randomly selected in blindfolded manner. Each block will determine the order of entry in the intervention and control groups. Assuming choosing the DABC block means from left hand, first, and fourth, respectively, will be located in the control group, and the second, and third of participants will be located in the intervention group, respectively. Thus, fifteen blocks will be selected to complete the sampling, Blinding description: The study is single blind and only the participant and the statistical consultant are not aware that the participant is in the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronavirus Disease (COVID-19).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the Intervention Group, a 2-3 Hour Training Session is Held Under The Title of one-day Training Workshop Through Multimedia Software (Audio, Video, Image) and Related Platforms Including WhatsApp, Imo and Telegram, for Patients and Caregivers of the Same Patients. And training on the disease and ways to prevent its transmission, attention to quarantine time, location (features of the quarantine room, disinfection of the quarantine room, patient areas such as bathrooms and toilets), social communication, diet and medication In quarantine, psychological issues (psychological strategies for stress management), having a healthy lifestyle, sleeping and resting in quarantine, management of outpatient care (weakness and lethargy, fever and body aches, loss of sense of smell, nausea and vomiting, diarrhea, Ventilation, adequate nutrition, adequate fluids, providing minimum facilities for psychosocial support) are provided to the patient and caregiver. After That, in the Intervention group, Telephone Follow-up Will Be Done Daily for one Month in the First Two Weeks and Two Days in the Second Two Weeks. An Agreement is Reached Regarding Follow-up Times and Calls, and The Contact Number of The Researcher and WhatsApp, Imo, Telegram and SMS Media are Provided to the Participants so that They can Communicate and Ask their Questions Whenever Necessary. Depending on the Condition of the Caregiver and the Patient, and Depending on Which Stage of The Disease the Patient is in, There is Training and Related Care Appropriate to that Stage of the Disease, and If Necessary, the Patient is Referred to an Infectious Disease Specialist. Remote Nursing Recommendations are also Given to Prevent Infection Transmission, Patient Recovery, and Outpatient Problems. Intervention 2: Control group: Only Routine Hospital Care Will be Provided. The ward Nurse Provides The Necessary Training Related to Infection Control, Medication Use, Go to The Hospital If The Patient's Condition Worsens and Visit 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is For More Security of Participants' Data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Rajab Dizavandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9157863346</zip>
        <telephone>+98 51 3212 7476</telephone>
        <email>ahmad.r.dizavandi@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4401 8308</telephone>
        <email>mostafarad633@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent to participate in the study
Age Over 30 Years and Maximum 60 Years
No Hearing Or Vision Disorders (Deaf And Dumb)
Lack of Clear Mental and Cognitive Impairment and Severe Mood-Emotional Disorder That Prevents Effective Communication
No Event Or a Stressful Event in The Last 6 Months for the Patient
Speak Persian or Understand Persian (Or Have a Companion Who Dominate in Persian)
Be Able To Read or Write (Or Have a Companion Him Literacy For Reading and Writing)
Patients living with Family
Patients in Live in House Quarantine
Failure To Participate in The Empowerment Program
Have a Diagnosis of Covid-19 (positive PCR test)
Having a Home Phone or Cell Phone
Be Careful
Have Experienced the Same Conditions for Covid-19 Disease.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The Patient's Unwillingness To Participate in The Study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the Intervention Group, a 2-3 Hour Training Session is Held Under The Title of one-day Training Workshop Through Multimedia Software (Audio, Video, Image) and Related Platforms Including WhatsApp, Imo and Telegram, for Patients and Caregivers of the Same Patients. And training on the disease and ways to prevent its transmission, attention to quarantine time, location (features of the quarantine room, disinfection of the quarantine room, patient areas such as bathrooms and toilets), social communication, diet and medication In quarantine, psychological issues (psychological strategies for stress management), having a healthy lifestyle, sleeping and resting in quarantine, management of outpatient care (weakness and lethargy, fever and body aches, loss of sense of smell, nausea and vomiting, diarrhea, Ventilation, adequate nutrition, adequate fluids, providing minimum facilities for psychosocial support) are provided to the patient and caregiver. After That, in the Intervention group, Telephone Follow-up Will Be Done Daily for one Month in the First Two Weeks and Two Days in the Second Two Weeks. An Agreement is Reached Regarding Follow-up Times and Calls, and The Contact Number of The Researcher and WhatsApp, Imo, Telegram and SMS Media are Provided to the Participants so that They can Communicate and Ask their Questions Whenever Necessary. Depending on the Condition of the Caregiver and the Patient, and Depending on Which Stage of The Disease the Patient is in, There is Training and Related Care Appropriate to that Stage of the Disease, and If Necessary, the Patient is Referred to an Infectious Disease Specialist. Remote Nursing Recommendations are also Given to Prevent Infection Transmission, Patient Recovery, and Outpatient Problems.</i_keyword>
      <i_keyword>Control group: Only Routine Hospital Care Will be Provided. The ward Nurse Provides The Necessary Training Related to Infection Control, Medication Use, Go to The Hospital If The Patient's Condition Worsens and Visit Again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver Burden in Family Caregivers'. Timepoint: Before and After one Month of Intervention. Method of measurement: Novak and Guest Caregiver Burden Questionnaire (1989).</prim_outcome>
      <prim_outcome>Self-Efficacy of Patients With Covid-19. Timepoint: Before and After one Month of Intervention. Method of measurement: Prevention, Recognition and Home-Management Self-Efficacy Scale (COVID-19-SES).</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-08</approval_date>
        <contact_name>Research Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs,  Blvd of Nuclear Martyrs Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
