<?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>IRCT20180417039341N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-13</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of self-care education on self-efficacy and quality of life in adolescents with congenital heart disease</public_title>
      <acronym></acronym>
      <scientific_title>To compare the effectiveness of self-care education in two methods, face to face and video educational, on the self-efficacy and quality of life in adolescents with congenital heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>111</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30751</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Congenital Heart Disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Face to face education individually per person in two sessions of 35 to 45 minutes, intervals of one week about 1- Description of heart defect and treatment 2- Prevention of complications 3- Physical activities 4. Fertility and genetic health 5 Prevention and Pregnancy Program. Intervention 2: Second intervention group: Educational video clip In this study, a compact disc was developed by a researcher and assisted by a media consultant, which included educational content: a description of congenital heart disease and treatment in summary and simple language, along with moving pictures, teaching common complications And prevention of them in the form of lectures, the scope of physical activity in different patients, the education of reproductive health and appropriate prevention methods in the form of lectures. Intervention 3: Control group: Get a routine hospital training program.</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:
Individual data of the participants as well as the final results of self-efficacy and their quality of life in the study after unidentifiable individuals can be shared.

When:
Start the 6 month period after the results are printed

To whom:
All individuals can use the results of this research if necessary.

Conditions:
Using the results of the research to raise the level of science and also use its results in conducting other research.

Where to obtain:
Parisa hasannezhad:
Email: parisa.hasannezhad@yahoo.com
Address: Shaheed Rajaei Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection., Tehran., Iran

How to obtain:
After registering the data, the applicant, upon request, sends the email to the researcher, and the purpose of the request is to explain the results and the results, and will be sent to them by email within the shortest possible time after the review by the researcher.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Hasannezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 2392 2477</telephone>
        <email>hassannejad.p@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Hasannezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 2392 2477</telephone>
        <email>hassannejad.p@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-21 year-old adolescents with congenital heart disease who have come to the clinic at least once a year.
The adolescents has the consent to participate in the study.
Have at least the ability to read and write.
At least 6 months have passed since the initial diagnosis of their illness.
A home theater display device to see the educational video.
Has not participated in similar educational programs (with the exception of the routine program) over the past year.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>21 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hearing and vision impairment, and other chronic diseases.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital malformation of heart, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Face to face education individually per person in two sessions of 35 to 45 minutes, intervals of one week about 1- Description of heart defect and treatment 2- Prevention of complications 3- Physical activities 4. Fertility and genetic health 5 Prevention and Pregnancy Program.</i_keyword>
      <i_keyword>Second intervention group: Educational video clip In this study, a compact disc was developed by a researcher and assisted by a media consultant, which included educational content: a description of congenital heart disease and treatment in summary and simple language, along with moving pictures, teaching common complications And prevention of them in the form of lectures, the scope of physical activity in different patients, the education of reproductive health and appropriate prevention methods in the form of lectures</i_keyword>
      <i_keyword>Control group: Get a routine hospital training program</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score in SHERER questionnaire. Timepoint: Measurement of self-efficacy at the beginning of the study (before intervention) and 2 months after face-to-face training and educational video clip. Method of measurement: SHERER Self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life Score in the WHO Quality of Life-BREF  Questionnaire. Timepoint: Measurement of quality of life at the beginning of the study (before intervention) and 2 months after face-to-face training and video clip training. Method of measurement: WHO Quality of Life-BREF  Quality of Life Questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-06</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
