<?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>IRCT20210427051101N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessment the effect of virtual self-care education on COVID-19 anxiety, among the community dwelling elderly</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the effect of virtual self-care education on COVID-19 anxiety, among the community dwelling elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>122</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55906</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling is by block random sampling method and participants are divided into two groups of intervention and control. Given the sample size, n blocks of 4 are required for random block allocation. The intervention group will be displayed with A and the control group with B. Blocks of size 4 can be six modes 1-AABB 2-ABAB 3-ABBA 4- BBAA 5- BABA 6-BAAB. Then we roll the dice, for example 4 comes to BBAA, we roll the dice again, for example 5 comes to BABA, and so on, we repeat and roll the dice until all the samples are allocated. In order to hide the random allocation from the researcher, a dark envelope sample size is prepared and each of the random sequences created is recorded on a card and placed inside the envelope and finally the envelope lid is pasted. At the time of enrollment in the study, according to the order of entry of samples, one of the envelopes is opened in order and the group of the sample is specified, Blinding description: Participants are randomly divided into control and intervention groups. Then the trainings are provided to the intervention group and every three weeks the participants in the control and intervention group are followed up through WhatsApp messenger. Therefore, participants are unaware of their position in the group and the type of intervention performed.
Due to the use of dark envelopes and English letters for random assignment of participants, the researcher is unaware of the location of participants and a name is determined for each person based on computer coding, and the researcher follows people through this and during the call. Due to the coding of individuals, it is unaware of their random allocation.
The outcome assessor and data analyst reviews and announces the results using data encoding.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19 anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the intervention includes physical, psychological and social self-care training related to Covid-19, which is in the form of podcasts and videocasts and is recorded in approximately 20 to 30 minutes and is designed according to their level of understanding; Participants are uploaded to WhatsApp messengers and given Covid-19 self-care tutorials for 6 consecutive sessions. Then, once every three weeks, in order to prevent the participants from leaving the research according to the exit criteria, the elderly are followed up through video calls in WhatsApp messengers. The trainings are in three dimensions: physical, mental and social and are presented to the participants during 5 educational parts and 1 review of previous trainings. Thus, the educational content of each session of the intervention will be based on the dimensions of self-care according to the following text:     1.Covid-19 and how to transmit it, disease prevention, how to use masks, gloves, alcohol, food hygiene, environmental health and clothing    2. Common and uncommon symptoms in Covid-19 disease, how to check the symptoms, time of test, necessary health and care measures at the time of symptoms    3. Quarantine and the ability to adapt to psychological and social stress     4. Food recommendations in quarantine, sports activities in quarantine, social activities in quarantine      5. Care recommendations for using public transportation and travel     6. Review of the mentioned topics. Intervention 2: Control group: For the control group, no intervention will be done, only once every three weeks to prevent the participants in the study to leave according to the exit criteria, follow-up of the elderly is done through video call in WhatsApp messengers. At the end of the intervention, training files will be provided to the participants of the control group.</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:
Considering that the present study is an academic dissertation and a copy of it will be provided to Tehran University of Medical Sciences; Therefore, all data is potentially shareable after identifying individuals.

When:
The time period for accessing the documents of this study is 3 months after the publication of the results.

To whom:
The data and documents of this study will be available to researchers working in academic and scientific institutions.

Conditions:
All researchers working in scientific and academic centers, including professors, students of all medical, nursing and paramedical degrees, nurses working in hospitals and community health centers, physicians, psychologists and other paramedical disciplines, request permission to receive unidentified data of this study. 
The use of the documents of this study can be used for all the mentioned groups only by mentioning the source and without any interference in its texts.

Where to obtain:
Considering that a copy of the dissertation will be provided to the library of the School of Nursing and Midwifery of Tehran University of Medical Sciences; Therefore, clients can visit the library of this center in person at the address: Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery, Tehran University of Medical Sciences; Phone number: +982166927171; Or visit the library site of Tehran University of Medical Sciences in absentia at http://lib.tums.ac.ir/ to benefit from the documents of this study.

How to obtain:
If the client visit the library of the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences in person, he can read the research documents in the library by introducing himself to the librarian and presenting a valid ID card. It should be noted that the client will not be allowed to take the document out of the library and take a photo of it.
If the client visit the library site of Tehran University of Medical Sciences in absentia, the client will enter a part of the study title in the search box and a summary of the present study will be displayed for him.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Amirzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8, 7.35 street, 7th of Nirouhavaie Ave, Damavand Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1748953637</zip>
        <telephone>+98 21 7740 4673</telephone>
        <email>maryam.amdg@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sarieh Poortaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St. (Nosrat Sharghi), School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 1144</telephone>
        <email>spoortaghi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 60-74 years
Having and being able to use a smart phone
Internet access
Be literate
Ability to see and hear
Ability to perform their daily activities (score 13 and above based on ADL tools)
Satisfaction with participating in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>74 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Score 16 or more in the Generalized Anxiety Disorder Questionnaire (GAD-7)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</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: In this study, the intervention includes physical, psychological and social self-care training related to Covid-19, which is in the form of podcasts and videocasts and is recorded in approximately 20 to 30 minutes and is designed according to their level of understanding; Participants are uploaded to WhatsApp messengers and given Covid-19 self-care tutorials for 6 consecutive sessions. Then, once every three weeks, in order to prevent the participants from leaving the research according to the exit criteria, the elderly are followed up through video calls in WhatsApp messengers. The trainings are in three dimensions: physical, mental and social and are presented to the participants during 5 educational parts and 1 review of previous trainings. Thus, the educational content of each session of the intervention will be based on the dimensions of self-care according to the following text:     1.Covid-19 and how to transmit it, disease prevention, how to use masks, gloves, alcohol, food hygiene, environmental health and clothing    2. Common and uncommon symptoms in Covid-19 disease, how to check the symptoms, time of test, necessary health and care measures at the time of symptoms    3. Quarantine and the ability to adapt to psychological and social stress     4. Food recommendations in quarantine, sports activities in quarantine, social activities in quarantine      5. Care recommendations for using public transportation and travel     6. Review of the mentioned topics</i_keyword>
      <i_keyword>Control group: For the control group, no intervention will be done, only once every three weeks to prevent the participants in the study to leave according to the exit criteria, follow-up of the elderly is done through video call in WhatsApp messengers. At the end of the intervention, training files will be provided to the participants of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety Score Based on Coronavirus Pandemic Anxiety Scale. Timepoint: Measurement of anxiety level at the beginning of the study and two weeks after the end of the intervention (8 weeks after the start of the study). Method of measurement: Coronavirus Pandemic Anxiety Scale (CPAS-11).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-25</approval_date>
        <contact_name>Joint Organizational Ethics Committee of the School of Nursing and Midwifery with the Faculty of Reh</contact_name>
        <contact_address>No. 8, Unit 5, 7/35 Alley, Simetri Niroohavayie St, Damavand St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
