<?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>IRCT20221123056586N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-07</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact of virtual reality on health and anxiety and care of Alzheimer's patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of virtual social network interaction of family caregivers of Alzheimer's patients on their depression, anxiety and stress</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study in question has two control and test groups, no intervention is performed on the control group and only one type of intervention is performed on the test group, Randomization description: After sampling, a number between 1 and 80 is assigned to each of the samples, then using the random site, the numbers are randomly divided between two groups, and as a result, the samples are divided into two control and test groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Alzheimer's disease. Condition 2: Dementia. Condition 3: Aged, Elder. Condition 4: Anxiety. Condition 5: Stress. Condition 6: Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: creating a group in the virtual messenger for the discussion of the users of this group in such a way that the identity of each person remains anonymous to other people. designing a one-month program after the initial needs assessment in the first meetings to communicate and present to the samples of the participants in this group; Discussions in the group are in accordance with the daily designed topics. The role of researchers is to facilitate and guide group discussions. In this group, the representative and the secretary of Alzheimer's Association of Iran in Yazd will also be members to participate in group discussions. Intervention 2: Control group: No intervention is performed on this 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:
All data is potentially shareable after de-identifying individuals.

When:
The access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
The data will only be available to researchers working in academic and scientific institutions and will be sent to individuals via email.

Where to obtain:
m.beyki71@gmail .com

How to obtain:
Apply via email, then introduce yourself and the reason for this request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Beyki sarvolia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Qandi St., Safir Omid Square, Jam-e Jam St., Noor Tower, Unit B82</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8949193118</zip>
        <telephone>+98 35 3822 6854</telephone>
        <email>m.beykisarvolia@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Beyki sarvolia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Qandi St., Safir Omid Square, Jam-e Jam St., Noor Tower, Unit B82</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8949193118</zip>
        <telephone>+98 35 3822 6854</telephone>
        <email>m.beykisarvolia@stu.ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
The caregiver has a family relationship with a patient with Alzheimer's
Age above 18 years
At least one month of continuous care for a patient with Alzheimer's disease
Care burden score of at least 22 with Zarit tool
Not suffering from cognitive impairment
Caregiver not taking psychoactive drugs
Having at least reading and writing literacy
Internet and smartphone access
Willingness and possibility to use the virtual messenger program
Farsi language</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Experience of participating in face-to-face or virtual programs regarding the challenges of caregivers and how to care for a patient with Alzheimer's
Existence of severe crisis such as death of loved ones or divorce in the last month
Caregiver's severe illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30.1</hc_code>
      <hc_code>F03</hc_code>
      <hc_code>R54</hc_code>
      <hc_code>F41.9</hc_code>
      <hc_code>Z73.3</hc_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer's disease with late onset</hc_keyword>
      <hc_keyword>Unspecified dementia</hc_keyword>
      <hc_keyword>Age-related physical debility</hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Stress, not elsewhere classified</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: creating a group in the virtual messenger for the discussion of the users of this group in such a way that the identity of each person remains anonymous to other people. designing a one-month program after the initial needs assessment in the first meetings to communicate and present to the samples of the participants in this group; Discussions in the group are in accordance with the daily designed topics. The role of researchers is to facilitate and guide group discussions. In this group, the representative and the secretary of Alzheimer's Association of Iran in Yazd will also be members to participate in group discussions.</i_keyword>
      <i_keyword>Control group: No intervention is performed on this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in the 42-question depression, anxiety and stress questionnaire. Timepoint: Measuring the level of depression before the intervention and one month after the intervention. Method of measurement: 42-question depression, anxiety and stress questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score in the 42-question depression, anxiety and stress questionnaire. Timepoint: Measuring the level of anxiety before the intervention and one month after the intervention. Method of measurement: 42-question depression, anxiety and stress questionnaire.</prim_outcome>
      <prim_outcome>Stress score in the 42-question depression, anxiety and stress questionnaire. Timepoint: Measuring the level of stress before the intervention and one month after the intervention. Method of measurement: 42-question depression, anxiety and stress questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Care burden score. Timepoint: Care burden score before intervention. Method of measurement: Zarit Care Burden Questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-16</approval_date>
        <contact_name>Research/Ethics committees of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Yazd, Shahid Qandi St., Sefir Omid Square, Jam Jam St., Noor Tower, Unit B82 Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
