<?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>IRCT20230219057453N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the impact of the empowerment program on psoriasis patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of a comprehensive remote empowerment program on the quality of life and medication adherence of patients with psoriasis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: during two stages; The first step is the convenience sampling. In the second stage, patients will be allocated in two intervention and control groups by random block allocation method. The samples are randomly assigned to quadruple blocks A, A, B, B in random groups. So that 16 blocks of 4 letters A and B are made up.Then a block is randomly selected. RAS random allocation software will be used to randomly select blocks. A indicates sample placement in intervention group and B indicates sample placement in control group. First, a block will be randomly identified by RAS software and then the first eligible sample will be entered into the intervention or control group according to the order of the letters A or B. Sampling will continue until all samples are selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>psoriasis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At the beginning of the study, the study questionnaires including demographic information questionnaire, perceived stigma, quality of life and medication adherence were completed by the patients of both control and intervention groups. This study will be conducted for 7 weeks and the control group will receive the usual care, while the patients of the intervention group will also receive the comprehensive empowerment program in addition to the usual care. In this way, the intervention group will be joined by the researcher in virtual groups of 10 to 15 people in the WhatsApp social network and will receive the comprehensive empowerment program. In this research, a 7-week empowerment program will be held online and on the platform of virtual networks according to the patients' conditions, and each week will address a specific topic to promote self-care. The content of each of the sessions will be provided to all patients of the intervention group in the same way as a combination of online and offline sessions (4 online sessions and 3 offline sessions) with an interval of one week for 7 weeks. Or the training video will be sent in the virtual network groups and in the online meetings, the Skyroom link will be placed in the virtual network group to hold online group meetings. Online group meetings with members of groups of 10 to 15 people will be held on the virtual network for 10 minutes and through the Skyroom platform. became. Intervention 2: Control group: Control group: study questionnaires including demographic information questionnaire, perceived stigma, quality of life and drug treatment adherence are completed by patients of both control and intervention groups. This study will be conducted in 7 weeks and the control group will receive the usual care.</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 can be shared after de-identifying the participants

When:
Start access after receiving information and data forever

To whom:
All applicants working in academic and scientific institutions

Conditions:
The use of data and documents in scientific research is unimpeded.

Where to obtain:
ایمیل arasti@tums.ac.ir

How to obtain:
Apply by email and after receiving the email up to 2 months later

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sayede Sara Mirhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Kargarshamali Street, Amirabad, Dormitory of Medical Sciences for Girls</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955975</zip>
        <telephone>+98 930 264 4173</telephone>
        <email>saramirhosseini1400@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr Arezoo Rasti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tawheed Square, Nosrat St., Faculty of Nursing and Midwifery, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>arasti@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Personal consent of the person to participate in the program
Adults 18 to 65 years old
Medical diagnosis of psoriasis according to the patient's medical record
Being in a stable state of illness
Having at least reading and writing literacy
Ability to communicate
Access and ability to use a smart phone and the Internet</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosed mental and cognitive disorders
Previous participation in similar empowerment programs
History of suicide</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Psoriasis</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: At the beginning of the study, the study questionnaires including demographic information questionnaire, perceived stigma, quality of life and medication adherence were completed by the patients of both control and intervention groups. This study will be conducted for 7 weeks and the control group will receive the usual care, while the patients of the intervention group will also receive the comprehensive empowerment program in addition to the usual care. In this way, the intervention group will be joined by the researcher in virtual groups of 10 to 15 people in the WhatsApp social network and will receive the comprehensive empowerment program. In this research, a 7-week empowerment program will be held online and on the platform of virtual networks according to the patients' conditions, and each week will address a specific topic to promote self-care. The content of each of the sessions will be provided to all patients of the intervention group in the same way as a combination of online and offline sessions (4 online sessions and 3 offline sessions) with an interval of one week for 7 weeks. Or the training video will be sent in the virtual network groups and in the online meetings, the Skyroom link will be placed in the virtual network group to hold online group meetings. Online group meetings with members of groups of 10 to 15 people will be held on the virtual network for 10 minutes and through the Skyroom platform. became.</i_keyword>
      <i_keyword>Control group: Control group: study questionnaires including demographic information questionnaire, perceived stigma, quality of life and drug treatment adherence are completed by patients of both control and intervention groups. This study will be conducted in 7 weeks and the control group will receive the usual care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment compliance. Timepoint: Before the intervention, 2 weeks and 4 weeks after the intervention. Method of measurement: Moriski medication adherence questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention, 2 weeks and 4 weeks after the intervention. Method of measurement: Questionnaire of quality of life of World Health Organization,.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stigma. Timepoint: Before starting the intervention, 2 weeks and 4 weeks after the intervention. Method of measurement: Geisenberg et al.'s 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-17</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing and Midwifery, Tehran University of Medical Sciences</contact_name>
        <contact_address>Shahvarz Blvd., corner of Qods St., Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
