<?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>IRCT20190119042417N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of telephone based smoking cessation program in patients with coronary artery disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of telephone based smoking cessation program and hospital smoking cessation program in smoking cessation in patients with coronary artery disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43797</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals with inclusion criteria will be randomly assigned to one of two study groups after obtaining informed consent. Permuted Block Stratified Randomization with 2, 4, 6, and 8 random blocks with software of the same name (Block Stratified Randomization) will be used to generate the random list. To avoid selection bias, and to comply with allocation concealment the random list will be provided to the individual outside the sampling process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: One hour training course on heart disease risk factors and the long-term smoking cessation training program will be implemented by telephone counseling, which includes the following sections: An interview session including diagnostic interview and motivational interview will be conducted by a psychiatric resident. In this interview, the patient's attitude toward smoking, the consequences of smoking in cardiac patients and the benefits of quitting smoking will be assessed. The motivation to quit smoking will be assessed. Benefits of smoking cessation (In particular: five-year mortality reduction to half, reduction in surgical wound healing time, and reduction in pulmonary complications) And the risks of continued smoking (in particular: the increased likelihood of re-operation due to vessel congestion, the prolongation of hospital stay) will be explained to the patient. Afterwards the stages of smoking cessation and how to evaluate the patient after discharge will be explained. Patients will receive five 10-minute telephone consultations (2 days, 1 week, 3 weeks, 3 months and 5 months after discharge), which will be conducted by a trained nurse. In these consultations, the patient will be asked about whether or not to stop smoking. If the patient continues to smoke, the patient will be warned about the risk of heart disease and the dangers of continuing to smoke, and positive consequences of smoking cessation will be reminded if patient stops smoking. Intervention 2: Control group: One-hour training class on heart disease risk factors routinely taught to all hospitalized patients.</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:
The study protocol, informed consent form, participant data file, and study report will be shared.

When:
12 to 24 months after publication of study results.

To whom:
Researchers working in academic and scientific institutions

Conditions:
For use in review studies and meta-analyzes

Where to obtain:
Majid sadeghian
Tel:+989126008662
Email:sadeghian_5@yahoo.com

How to obtain:
The person in charge will respond to the request after receiving the email and review it within a maximum of one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Sadeghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 34, Kashfian Ave, Sheykhbahai St, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 8803 8050</telephone>
        <email>sadeghian_5@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Shamsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arabi Ave, Daneshjoo Blvd, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 8803 8050</telephone>
        <email>ar.shamsi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consume at least five cigarettes daily for at least one month before admission
Suffering from coronary artery disease
Attempted to quit smoking following coronary artery disease
Patient consent for inclusion in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Language problems that the patient is unable to complete the questionnaire
Unstable clinical condition
Patients with dementia (according to history)
Patients with delirium (lack of awareness to time, place, or person at interview time)
patient that cannot be reached by telephone for follow up</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>One hour training course on heart disease risk factors and the long-term smoking cessation training program will be implemented by telephone counseling, which includes the following sections: An interview session including diagnostic interview and motivational interview will be conducted by a psychiatric resident. In this interview, the patient's attitude toward smoking, the consequences of smoking in cardiac patients and the benefits of quitting smoking will be assessed. The motivation to quit smoking will be assessed. Benefits of smoking cessation (In particular: five-year mortality reduction to half, reduction in surgical wound healing time, and reduction in pulmonary complications) And the risks of continued smoking (in particular: the increased likelihood of re-operation due to vessel congestion, the prolongation of hospital stay) will be explained to the patient. Afterwards the stages of smoking cessation and how to evaluate the patient after discharge will be explained. Patients will receive five 10-minute telephone consultations (2 days, 1 week, 3 weeks, 3 months and 5 months after discharge), which will be conducted by a trained nurse. In these consultations, the patient will be asked about whether or not to stop smoking. If the patient continues to smoke, the patient will be warned about the risk of heart disease and the dangers of continuing to smoke, and positive consequences of smoking cessation will be reminded if patient stops smoking.</i_keyword>
      <i_keyword>Control group: One-hour training class on heart disease risk factors routinely taught to all hospitalized patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Smoking cessation. Timepoint: at baseline and after 6 months. Method of measurement: 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-24</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of medical sciences</contact_name>
        <contact_address>Shahid Beheshti university of medical siences, Aarabi Ave, Yaman Ave, Chamran St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
