<?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>IRCT20141109019862N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-11</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention based on the theory of planned behavior on self-management behavior in heart attack patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on the theory of planned behavior on self-management behavior of patients with acute coronary syndrome (ACS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66287</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: The study is an educational intervention. By referring to the relevant ward, patients are selected based on the inclusion and exclusion criteria in the study and are placed in the control and intervention groups based on even and odd days, respectively. The control group receives the usual care of the ward. In addition to the usual interventions, the intervention group participates in training sessions designed based on the constructs of the theory of planned behavior.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Acute coronary syndrome (ACS). Condition 2: Self-management.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention is an educational intervention that has been prepared using reliable and up-to-date sources and has been approved by experts. Before the intervention, the overall score of each of the theoretical constructs as well as the overall score of the patients' self-management behavior is determined using a questionnaire. Then, in addition to routine care, the intervention group will participate in 5 training sessions (0.5 to 1 hour). After the implementation of the educational program for the intervention group and two months have passed, the questionnaire will be completed for them  to determine the effect of the intervention on the patients under study. Intervention 2: Control group: This group will only receive routine care. The questionnaire will complete twice by them. Once at the beginning of the study and the second time 2 months after filling the first questionnaire. At the end of the work and after filling the second questionnaire, in order to comply with ethics, educational materials are also provided to them.</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:
A summary of the project in the form of an end of project report and article

When:
Completion of the plan

To whom:
Researchers in the field of health sciences

Conditions:
Literature review, evidence-based medicine and nursing, modeling for similar diseases

Where to obtain:
To published articles and contact authors

How to obtain:
Apply by email to the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Skineh Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft-Bagh Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>s_sabzevari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sakineh Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh Blvd, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617796777</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>S_Sabzevari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All conscious patients, referred to this hospital, in whom the clinical and paraclinical diagnosis of ACS has been confirmed and are now ready to be discharged
No participating in other studies or training sessions similar to this research during the last 6 months
Having a smart phone and the ability to work with it</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of minimum reading and writing literacy
Inability to salf-care (dependence on others) for any reason except ACS based on Barthel's ADL tool (completely dependent (0-8 points), relative dependence (9-12 points), Complete independence (13-20 points)} is determined.
History of psychological disorder (use of antipsychotic drugs) which is determined based on the self-report of the patient or the patient's companion
Cardiovascular disease as a complication of another chronic disease
Congenital heart disease
Inability to answer questions due to the disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.9</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute ischemic heart disease, unspecified</hc_keyword>
      <hc_keyword></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: The intervention is an educational intervention that has been prepared using reliable and up-to-date sources and has been approved by experts. Before the intervention, the overall score of each of the theoretical constructs as well as the overall score of the patients' self-management behavior is determined using a questionnaire. Then, in addition to routine care, the intervention group will participate in 5 training sessions (0.5 to 1 hour). After the implementation of the educational program for the intervention group and two months have passed, the questionnaire will be completed for them  to determine the effect of the intervention on the patients under study.</i_keyword>
      <i_keyword>Control group: This group will only receive routine care. The questionnaire will complete twice by them. Once at the beginning of the study and the second time 2 months after filling the first questionnaire. At the end of the work and after filling the second questionnaire, in order to comply with ethics, educational materials are also provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attitude. Timepoint: At the beginning of the study (before the start of  intervention) and 2 months after  intervention. Method of measurement: A researcher-made questionnaire which reliability and validity have been confirmed.</prim_outcome>
      <prim_outcome>Perceived norm. Timepoint: At the beginning of the study (before the start of  intervention) and 2 months after  intervention. Method of measurement: A researcher-made questionnaire which reliability and validity have been confirmed.</prim_outcome>
      <prim_outcome>Perceived behavioral control. Timepoint: At the beginning of the study (before the start of  intervention) and 2 months after  intervention. Method of measurement: A researcher-made questionnaire which reliability and validity have been confirmed.</prim_outcome>
      <prim_outcome>Behavioral intention. Timepoint: At the beginning of the study (before the start of  intervention) and 2 months after  intervention. Method of measurement: A researcher-made questionnaire which reliability and validity have been confirmed.</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>personal expenses</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-04</approval_date>
        <contact_name>Research Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Jahad Blvd. Ebn Sina Avenue, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
