<?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>IRCT20100609004129N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-11</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation on the effectiveness of coronary artery bypass graft surgery patients and their caregivers' burden.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of rehabilitation through the home visit and telephone follow up on self-efficacy in coronary artery bypass graft patients and their family caregivers' burden.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32697</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The studied units (patient and caregiver) will be assigned to the three groups according to the criteria for inclusion in the study and available on the basis of randomized blocking. The entry of individuals to each of the groups will be done in the order of the number of selected blocks and will be done using the layout inside the block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>self-efficacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Visit at home with the presence of a nurse in coordination with the patient's home and assess and train her for 4 weeks, weekly 1 time (4 sessions each), and each time for about an hour, from the first day after discharge. Complete the patient's questionnaire and care and delivery of the Educational booklet, patient counseling and family about the lifestyle modification including risk management, assessment of sleep status, nutrition, appetite and excretion, drug use and drug complications, mood and mental state of the patient, stopping use Smoking, wound care, referral to doctor, personal hygiene, bathing, sex work, traveling, driving, prayer Dan, climbing stairs, pressure, and blood sugar control is carried out, at the end of the rehabilitation program, during the last visit, this will be questionnaires completed by patients and caregivers. Intervention 2: Intervention group2 : Telephone follow up, telephone training and counseling based on the 2 weekly rehabilitation program for 4 weeks (totaling 8 telephone calls) and each call approximately 30 minutes from the first day after discharge by completing the patient and caregiver questionnaire and delivering the educational booklet. , And counseling and training, such as a home visit group, and completing questionnaires on the last day of the 4th week with the researcher's visit to the home. Intervention 3: Control group: From the first day of discharge after the discharge, by completing the patient and caregiver questionnaire, according to the routine of the treatment center during the discharge of the patient from the hospital, the training was provided by providing the hospital training package and completed the questionnaire on the last day of the 4th week The researcher will go home.</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 Failure to complete the study

No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Shirin Hasanwand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ground floor, Danesh 5th Alley, Danesh Street, Sepahan St., 60meter Street</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819833895</zip>
        <telephone>+98 66 3341 9023</telephone>
        <email>goharif52@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shirin Hasanwand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ground floor, Danesh 5th Alley, Danesh Street, Sepahan St., 60meter Street</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819833895</zip>
        <telephone>+98 66 3341 9123</telephone>
        <email>hasanvand.sh1390@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing coronary artery bypass graft surgery
Familiarity with Persian language, Laki and accent Lori
The absence of mental or psychomotor disorder
The absence of  hearing impairment, vision, speech,
The absence of  chronic disease disability
Access to fixed telephony
Having a caregiver available during admission
Aged 18 and over(caregiver )
Have a reading and writing literacy (caregiver )</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>previous record of participation in cardiac rehabilitation programs
The incidence of the disease Systemic
The incidence hemodynamic disorder
Literacy is not read and write (caregiver )
Having known psychomotor disorder (caregiver )</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Visit at home with the presence of a nurse in coordination with the patient's home and assess and train her for 4 weeks, weekly 1 time (4 sessions each), and each time for about an hour, from the first day after discharge. Complete the patient's questionnaire and care and delivery of the Educational booklet, patient counseling and family about the lifestyle modification including risk management, assessment of sleep status, nutrition, appetite and excretion, drug use and drug complications, mood and mental state of the patient, stopping use Smoking, wound care, referral to doctor, personal hygiene, bathing, sex work, traveling, driving, prayer Dan, climbing stairs, pressure, and blood sugar control is carried out, at the end of the rehabilitation program, during the last visit, this will be questionnaires completed by patients and caregivers.</i_keyword>
      <i_keyword>Intervention group2 : Telephone follow up, telephone training and counseling based on the 2 weekly rehabilitation program for 4 weeks (totaling 8 telephone calls) and each call approximately 30 minutes from the first day after discharge by completing the patient and caregiver questionnaire and delivering the educational booklet. , And counseling and training, such as a home visit group, and completing questionnaires on the last day of the 4th week with the researcher's visit to the home.</i_keyword>
      <i_keyword>Control group: From the first day of discharge after the discharge, by completing the patient and caregiver questionnaire, according to the routine of the treatment center during the discharge of the patient from the hospital, the training was provided by providing the hospital training package and completed the questionnaire on the last day of the 4th week The researcher will go home.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient Self-efficacy. Timepoint: During discharge from the hospital one month after the discharge. Method of measurement: Joker  Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Caregivers burden, family Caregivers. Timepoint: During the discharge of the hospital and completion of the intervention up to 4 weeks after discharge. Method of measurement: Novak and Gest Questionnaire.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-25</approval_date>
        <contact_name>Ethics committee of lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaie Square, Moaalem St Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
