<?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>IRCT20130211012439N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-16</date_registration>
      <primary_sponsor>Faculty of Medical Sciences, Tarbiat Modares University</primary_sponsor>
      <public_title>Comparative evaluation of discharge planning and cardiac rehabilitation on the health outcomes of patients undergoing coronary artery bypass graft surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of discharge planning based on continuous care model and routine cardiac rehabilitation on the health related outcomes of patients undergoing coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36344</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study will take place in two phases of quantitative and qualitative. In the quantitative phase, a clinical trial is conducted and in a qualitative phase, the nested mixed method is conducted through directed content analysis. Patients in the intervention group will be interviewed during the study and the data will be analysed through thematic analysis, Randomization description: First of all, from patients with coronary artery bypass graft surgery and having inclusion criteria, a sample is selected according to the sampling method and based on balance block randomization method will be placed in cardiac rehabilitation group with education based on continuous care model (intervention) and the cardiac rehabilitation group (control). For this purpose, four sheets of paper are provided by the researcher, writing on two sheets “1” for “first” and on two “2” for second”. The paper sheets will be pooled, placed in a container, and randomly will be drawn one at a time for each patient without replacement until all four sheets are drawn. Then, the four paper sheets will be placed back into the container and this action will be repeated until the sample size is reached, Blinding description: The cardiac rehabilitation nurse performed the assessments at each time point; she was blinded to random allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients undergoing coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: after introduction of the study and statement of the purposes, the patients will provide informed consents and complete the demographics form, quality of life questionnaire and Depression, anxiety and stress scale. Also, an exercise test will be done with a treadmill. Then, the Continuous Care Model will be presented to the participants along with cardiac rehabilitation program for four months. The Continuous Care Model consists of four stages: (1) orientation, (2) sensitization, (3) control, and (4) evaluation. At the end of one and four months, quality of life questionnaire and Depression, anxiety, and stress scale will be completed and an exercise test will be done. Intervention 2: Intervention control: In this group, patients will receive cardiac rehabilitation according to the routine program rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is I must provide all information for the sponsoring institution.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Pakrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-333</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>f.pakrad@modares.ac.ir</email>
        <affiliation>Faculty of Medical Sciences Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fazlollah Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-333</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>ahmadif@modares.ac.ir</email>
        <affiliation>Faculty of Medical Sciences Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients after coronary artery bypass graft surgery
The family and patient's willingness to participate in educational programs based on a continuous care model
Close relationship of family member with patient</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart Failure class III and IV
Severe musculoskeletal problems
Positive exercise test
did not have access to a smart phone
on medication for psychiatric disorders</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: after introduction of the study and statement of the purposes, the patients will provide informed consents and complete the demographics form, quality of life questionnaire and Depression, anxiety and stress scale. Also, an exercise test will be done with a treadmill. Then, the Continuous Care Model will be presented to the participants along with cardiac rehabilitation program for four months. The Continuous Care Model consists of four stages: (1) orientation, (2) sensitization, (3) control, and (4) evaluation. At the end of one and four months, quality of life questionnaire and Depression, anxiety, and stress scale will be completed and an exercise test will be done.</i_keyword>
      <i_keyword>Intervention control: In this group, patients will receive cardiac rehabilitation according to the routine program rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score in the short form questionnaire 36 questions. Timepoint: Before, immediately after and 3 months after the end of the intervention. Method of measurement: Short form questionnaire of quality of life.</prim_outcome>
      <prim_outcome>Measure functional capacity. Timepoint: Before, immediately after and 3 months after the end of the intervention. Method of measurement: Using a treadmill according to a modified Bruce protocol.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Re-hospitalization. Timepoint: Immediately after and 3 months after the end of the intervention. Method of measurement: through checking the computer system and directly querying patients (for potential hospitalizations elsewhere).</sec_outcome>
      <sec_outcome>Depression score in depression, anxiety and stress questionnaire. Timepoint: Before, immediately after and 3 months after the end of the intervention. Method of measurement: Depression Anxiety and Stress Scale.</sec_outcome>
      <sec_outcome>Anxiety score in depression, anxiety and stress questionnaire. Timepoint: Before, immediately after and 3 months after the end of the intervention. Method of measurement: Depression Anxiety and Stress Scale.</sec_outcome>
      <sec_outcome>Stress score in depression, anxiety and stress questionnaire. Timepoint: Before, immediately after and 3 months after the end of the intervention. Method of measurement: Depression Anxiety and Stress Scale.</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>Faculty of Medical Sciences, Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-05</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
