<?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>IRCT20220602055063N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-04</date_registration>
      <primary_sponsor>Shahid Rajaei Heart and Vascular Center, Tehran</primary_sponsor>
      <public_title>Comparison of the effect of telephone follow-up with social network follow-up on self-efficacy and depression in patients undergoing coronary artery bypass graft surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of telephone follow-up with social network follow-up on self-efficacy and depression in patients undergoing coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64049</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible patients to participate in the research will be selected in a continuous manner and will be divided into three control groups, telephone follow-up and follow-up through social network (whats app) using a random block method with a size of 6. In the random numbers table, they are prepared using random or random numbers by computers that adjust the numbers randomly. Then, each studied patient will be placed in one of the three groups based on the assigned number, and each patient will have an equal chance to be placed in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiovascular disease, depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Telephone follow-up - for each patient in this group, a telephone call will be made once a week for 15 minutes, in each telephone call the educational items needed by the patient during the discharge period, which include educational programs with medicinal components It will be care, diet and exercise. In the drug program, how to observe the correct use of medicines and in the care program, observe not to smoke, control pain, take care of the surgical incision site, maintain the balance of intestinal excretion, sleeping position,The state of vital signs and the recommendation to use motivational spirometry and the correct way to use the medical belt, and in the diet plan, the correct way to eat and suitable foods, and in the exercise program, the recommended activities and appropriate to the patient's medical and physical condition will be presented. This intervention will be implemented for one month for the telephone follow-up intervention group. Intervention 2: Intervention group 2: Social network follow-up (WhatsApp) - In this group, a channel will be set up for this purpose for patients, and for four weeks, weekly messages will be sent, which will include educational items needed by the patient in the course of Discharge, which will include educational programs with medication, care, diet and exercise components, will be sent. Intervention 3: Control group: The control group will receive only the follow-up and routine care of the center at the time of discharge and will not receive any intervention in this one month. After one month, the questionnaires will be sent online to the patients again and will be provided to the researcher after completion.</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:
Data related to depression and self-efficacy variables can be shared.

When:
5 months after printing the results

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
No special conditions

Where to obtain:
www.ako.5314@yahoo.com

How to obtain:
Apply by email

Comments:
....</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ako Hassanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei  Cardiovascular Training, Research and Treatment Center-next to Mellat Park-Wali Asr St. (AJ)-Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>ako.5314@yahoo.com</email>
        <affiliation>Shahid Rajaei Heart and Vascular Center, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ako Hassanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei  Cardiovascular Training, Research and Treatment Center-next to Mellat Park-Wali Asr St. (AJ)-Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>ako.5314@yahoo.com</email>
        <affiliation>Rajaie Cardiovascular, Medical and Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Coronary artery bypass graft surgery
Literacy
Full consciousness
Absence of speech, hearing and vision disorders
No history of using psychedelics or antidepressants
No history of pre-surgery depression
40% discharge deduction and having a landline phone at home or personal mobile phone
Ability to use WhatsApp
Internet access</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to  cooperation in research at any time of the study
Age over 80 years
Patients who undergo emergency surgery again due to postoperative complications.
The patient has new physical problems that make her lose the ability to take care of herself</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21,I22,</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction,Subsequent myocardial infarction,</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Telephone follow-up - for each patient in this group, a telephone call will be made once a week for 15 minutes, in each telephone call the educational items needed by the patient during the discharge period, which include educational programs with medicinal components It will be care, diet and exercise. In the drug program, how to observe the correct use of medicines and in the care program, observe not to smoke, control pain, take care of the surgical incision site, maintain the balance of intestinal excretion, sleeping position,The state of vital signs and the recommendation to use motivational spirometry and the correct way to use the medical belt, and in the diet plan, the correct way to eat and suitable foods, and in the exercise program, the recommended activities and appropriate to the patient's medical and physical condition will be presented. This intervention will be implemented for one month for the telephone follow-up intervention group.</i_keyword>
      <i_keyword>Intervention group 2: Social network follow-up (WhatsApp) - In this group, a channel will be set up for this purpose for patients, and for four weeks, weekly messages will be sent, which will include educational items needed by the patient in the course of Discharge, which will include educational programs with medication, care, diet and exercise components, will be sent.</i_keyword>
      <i_keyword>Control group: The control group will receive only the follow-up and routine care of the center at the time of discharge and will not receive any intervention in this one month. After one month, the questionnaires will be sent online to the patients again and will be provided to the researcher after completion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Beck questionnaire, self-efficacy score in Sullivan questionnaire. Timepoint: Filling questionnaires before discharge and then after one month. Method of measurement: Beck Depression Questionnaire, Sulivan Cardiac Patient Self-Efficacy Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: During discharge - one month after discharge. Method of measurement: SF12 short questionnaire with 12 questions.</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 Rajaei Heart and Vascular Center, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-16</approval_date>
        <contact_name>Research ethics committee of Shahid Rajaei cardiology, research and treatment center in Tehran</contact_name>
        <contact_address>Shahid Rajaei  Cardiovascular Training, Research and Treatment Center-next to Mellat Park-Wali Asr St. (AJ)-Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
