<?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>IRCT20230717058812N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Using Mobile Application on Improving Self-care of Children with Cystic Fibrosis</public_title>
      <acronym>CFA</acronym>
      <scientific_title>Comparison of Mobile Application Effectiveness on Self-care of Children with Cystic Fibrosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71337</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research units were patients who were matched in pairs in terms of age. Then, each pair was assigned to two intervention and control groups by a simple random allocation method with a coin.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cystic fibrosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: using the self-care application for cystic fibrosis children, after the entry of people who meet the entry criteria and obtaining written informed consent, with the help of a random number table, these people are divided into two intervention and control groups. In the intervention group, the desired application is installed on the smartphone of children with CF. Before the installation, the self-care questionnaire for patients with Baker's cystic fibrosis and the demographic characteristics questionnaire are completed by the participants. Then this application is used by this group for one month. Before the test of the written informed consent form, the demographic information questionnaire will be provided to the control and intervention groups. After one month, a self-care questionnaire for patients with Baker's Cystic Fibrosis is completed by the control and intervention groups, and the data collected in the pre-test and post-test stages are entered into the SPSS version 22 software and using descriptive and inferential statistics of the case The analysis will be placed. Intervention 2: Control group: not using the self-care application of cystic fibrosis children, the control group will also receive the usual training. It should be noted for to prevent the contamination of the control group samples, the desired application will be installed by the researcher and specifically with the help of each person's code on the phones of the intervention group. In order to comply with the ethical principles, after the end of the study, the application will be given to the people 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:
Only a part of the data, such as the information related to the main result or the like, can be shared.

When:
Year 1402-1403

To whom:
Doctors, nurses and specialists in the field of cystic fibrosis

Conditions:
For more comprehensive studies, obtain permission from the responsible person

Where to obtain:
Tehran University of Medical Sciences Faculty of Nursing and Midwifery Library

How to obtain:
Membership in the library of the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences

Comments:
.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Batool Pouraboli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4411</telephone>
        <email>b.pouraboli@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Batol Pouraboli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4411</telephone>
        <email>b.pouraboli@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged 11 to 20 who want to participate in the study
Membership in Iran CF Foundation
Access to a mobile phone and the ability to use the Android or IOS operating system
Ability to read and write</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having hearing, touch and vision disorders that make it impossible to gather information
Simultaneous participation in another similar training program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E84.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cystic fibrosis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: using the self-care application for cystic fibrosis children, after the entry of people who meet the entry criteria and obtaining written informed consent, with the help of a random number table, these people are divided into two intervention and control groups. In the intervention group, the desired application is installed on the smartphone of children with CF. Before the installation, the self-care questionnaire for patients with Baker's cystic fibrosis and the demographic characteristics questionnaire are completed by the participants. Then this application is used by this group for one month. Before the test of the written informed consent form, the demographic information questionnaire will be provided to the control and intervention groups. After one month, a self-care questionnaire for patients with Baker's Cystic Fibrosis is completed by the control and intervention groups, and the data collected in the pre-test and post-test stages are entered into the SPSS version 22 software and using descriptive and inferential statistics of the case The analysis will be placed.</i_keyword>
      <i_keyword>Control group: not using the self-care application of cystic fibrosis children, the control group will also receive the usual training. It should be noted for to prevent the contamination of the control group samples, the desired application will be installed by the researcher and specifically with the help of each person's code on the phones of the intervention group. In order to comply with the ethical principles, after the end of the study, the application will be given to the people of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Baker's Cystic Fibrosis Self-care Practice Instrument score. Timepoint: Before intervention and one month after intervention. Method of measurement: Baker's Cystic Fibrosis Self-care Practice Instrument.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Baker's Cystic Fibrosis Self-care Practice Instrument score. Timepoint: Before intervention and one month after intervention. Method of measurement: Baker cystic fibrosis self-care practice 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>Iran CF Foundation</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-19</approval_date>
        <contact_name>Ethics committee of children's medical center-Tehran university of medical sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
