<?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>IRCT20250130064570N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Group-Based In-Person and Mobile Phone–Based Education on Treatment Adherence and Self-Care Behaviors in Patients with Atrial Fibrillation: A Controlled Clinical Trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Group-Based In-Person and Mobile Phone–Based Education on Treatment Adherence and Self-Care Behaviors in Patients with Atrial Fibrillation: A Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: All participants completed the informed consent form prior to the start of the intervention. The initial questionnaire was completed by the research facilitator, after which each individual was given an envelope containing their assigned order of entry into the study, indicating to which educational group they belonged. Subsequently, the specific information for that group—including session schedules and the method of receiving educational materials—was provided to the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atrial fibrillation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The face-to-face group training was conducted using interactive methods such as Q&amp;A sessions, group discussions, lectures, podcasts, and short film screenings. The sessions took place in the auditorium of Tehran Heart Center, with 8 to 10 participants attending each session. The intervention in the face-to-face training group lasted approximately one month. Intervention 2: Intervention group: Mobile phone–based training was delivered through social media platforms, with content sent to participants’ personal social media accounts three times a week at regular intervals. Feedback from participants on each session’s content was collected within two days after the material was sent. Responses to the messages were considered as confirmation of content receipt by the user. The materials sent included images, podcasts, and short video clips.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Ashoorkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Pour Sina Street, Ghods Street, Enghelab Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>ashoorkhani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Ashoorkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Pour Sina Street, Ghods Street, Enghelab Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>ashoorkhani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People over 18 years of age with a diagnosis of atrial fibrillation
Being able to read and write
Being literate in using a mobile phone
Internet access
Access to one of the devices such as tablet, smartphone, and computer
People's willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of concurrent participation in another educational intervention related to this heart disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I48.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic atrial fibrillation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The face-to-face group training was conducted using interactive methods such as Q&amp;A sessions, group discussions, lectures, podcasts, and short film screenings. The sessions took place in the auditorium of Tehran Heart Center, with 8 to 10 participants attending each session. The intervention in the face-to-face training group lasted approximately one month.</i_keyword>
      <i_keyword>Intervention group: Mobile phone–based training was delivered through social media platforms, with content sent to participants’ personal social media accounts three times a week at regular intervals. Feedback from participants on each session’s content was collected within two days after the material was sent. Responses to the messages were considered as confirmation of content receipt by the user. The materials sent included images, podcasts, and short video clips.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Medication Adherence Score in Patients with Atrial Fibrillation. Timepoint: At baseline, three months, and six months after the start of the intervention. Method of measurement: Researcher-designed questionnaire assessing treatment adherence and self-care behaviors among patients with atrial fibrillation.</prim_outcome>
      <prim_outcome>Non-Pharmacological Treatment Adherence Score in Patients with Atrial Fibrillation. Timepoint: At baseline, three months, and six months after the start of the intervention. Method of measurement: Researcher-designed questionnaire assessing treatment adherence and self-care behaviors among patients with atrial fibrillation.</prim_outcome>
      <prim_outcome>Self-Care Behavior Adherence Score in Patients with Atrial Fibrillation. Timepoint: At baseline, three months, and six months after the start of the intervention. Method of measurement: Researcher-designed questionnaire assessing treatment adherence and self-care behaviors among patients with atrial fibrillation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number of visits to the emergency department of Tehran Heart Hospital in the past six months. Timepoint: Before the start of the intervention and six months after the start of the intervention. Method of measurement: One question about whether you have visited the emergency department of the heart hospital in the past six months, one question about the number of visits to the emergency department of the heart hospital during the past six months, and one question about the duration of your stay in the emergency department of the hospital.</sec_outcome>
      <sec_outcome>The number of hospital admissions to Tehran Heart Hospital in the past six months. Timepoint: Before the start of the intervention and six months after the start of the intervention. Method of measurement: One question about whether you have been admitted to the heart hospital in the past six months, one question about how many times you have been admitted to the heart hospital, and one question about the duration of your stay at the heart hospital during the past six months.</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 Heart Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-24</approval_date>
        <contact_name>کارگروه/کمیته اخلاق در پژوهش دانشکده بهداشت و پیراپزشکی-دانشگاه علوم پزشکی تهران</contact_name>
        <contact_address>Blvd., North Tabarsi 13- No. 18 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
