<?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>IRCT20230219057454N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-02</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of training on quality of life, quality of sleep and fatigue in cardiac patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of education based on continuous care model on quality of life, quality of sleep and fatigue in patients undergoing coronary artery bypass surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68713</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of life, quality of sleep and fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Description of the intervention in the intervention group: The stages of this model are: familiarization, sensitization, control and evaluation. The duration of the implementation of the continuous care model is 12 weeks, which includes a familiarization phase and 6 sensitization sessions in a period of four weeks and two control phases, and the evaluation is done by a questionnaire. The connected and coherent stages of the continuous care model are: Familiarization stage: The actions of this stage include introducing the trainer to the patient and family, clarifying the trainer's expectations in the study stages, specifying the patient's and his family's expectations and expectations, completing ethical consideration forms, Completing the questionnaire forms after selecting and accepting the patient and family through the press line, determining and agreeing on the time of training sessions, by phone and mentioning the goals and how to communicate, this step is done for both intervention and control groups. Sensitization stage: The actions of this stage include examining the situation and explaining the skill training needs of the patient and the family, explaining about the disease and the existing and possible resulting complications, examining the basic needs regarding the quality of life, sleep quality, fatigue and justifying the need to pay attention to it, explaining The problems are caused by the complications of the disease and addressing the desired questions and answers with an emphasis on the risk factors. Familiarization and sensitization stages will be held in the first 4 weeks of the implementation of the model in 6 sessions of 30 to 45 minutes according to the level of tolerance and acceptance of the patients.  At this stage, the quality of life, sleep quality and fatigue questionnaires are completed by the patients of the intervention group  .Control phase: The actions of this phase include direct and indirect evaluation of acquired skills, checking the stability of health behaviors, checking new needs with regard to new problems and re-sensitizing regarding problem solving, strengthening health behaviors and justifying the beneficial effects of actions with regard to improving the index. tangible things, controlling the studied variables, exchanging opinions about the success and failure of the measures taken, explaining the proposed solution with the help of the patient and family. In this stage, follow-up care consultations will be carried out frequently for two months with phone calls according to the care needs of the intervention group. Evaluation stage: The actions of this stage include the evaluation of the desired variables using questionnaires. Finally, this stage ends with completing the questionnaire  at the end of the first month and the end of the second month after the intervention. Intervention 2: Control group: : Familiarization stage: The first step in the continuous care model is familiarization, the purpose of which is mutual recognition (patient, family and teacher) and explanation of the model stages. The actions of this stage include introducing the trainer to the patient and the family, clarifying the trainer's expectations during the study stages, specifying the expectations and expectations of the patient and his family, completing the ethical consideration forms, completing the questionnaire forms after selecting and accepting the patient and the family through the press line. Determining and agreeing on the time of the training sessions, on the phone, and mentioning the goals and how the communication is possible which this process is done in the control stage.</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 In this plan, there is no need to publish information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Shahnazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave, School of Health, Isfahan University of Medical Sciences, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>h_shahnazi@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shahnazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave, School of Health, Isfahan University of Medical Sciences, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 3200</telephone>
        <email>h_shahnazi@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who have had at least 2 months of coronary artery bypass grafting (CABG) and have been admitted to Chamran Hospital and have a hospital record
Consent to participate in the study
Having  reading and writing literacy
Internet access
The ability to use virtual space to participate in web meetings and to use programs such as Skyroom
Resident of Isfahan</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Prohibition of physical activity as determined by the  physician
Having a special diet recommended by the physician
Having other disabilities such as blindness, deafness and mental retardation
Suffering from neurological, cerebro-vascular, psychiatric, urinary-genital disorders, being treated with psychiatric drugs (due to non-cardiac diseases) based on the patient's record</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Description of the intervention in the intervention group: The stages of this model are: familiarization, sensitization, control and evaluation. The duration of the implementation of the continuous care model is 12 weeks, which includes a familiarization phase and 6 sensitization sessions in a period of four weeks and two control phases, and the evaluation is done by a questionnaire. The connected and coherent stages of the continuous care model are: Familiarization stage: The actions of this stage include introducing the trainer to the patient and family, clarifying the trainer's expectations in the study stages, specifying the patient's and his family's expectations and expectations, completing ethical consideration forms, Completing the questionnaire forms after selecting and accepting the patient and family through the press line, determining and agreeing on the time of training sessions, by phone and mentioning the goals and how to communicate, this step is done for both intervention and control groups. Sensitization stage: The actions of this stage include examining the situation and explaining the skill training needs of the patient and the family, explaining about the disease and the existing and possible resulting complications, examining the basic needs regarding the quality of life, sleep quality, fatigue and justifying the need to pay attention to it, explaining The problems are caused by the complications of the disease and addressing the desired questions and answers with an emphasis on the risk factors. Familiarization and sensitization stages will be held in the first 4 weeks of the implementation of the model in 6 sessions of 30 to 45 minutes according to the level of tolerance and acceptance of the patients.  At this stage, the quality of life, sleep quality and fatigue questionnaires are completed by the patients of the intervention group  .Control phase: The actions of this phase include direct and indirect evaluation of acquired skills, checking the stability of health behaviors, checking new needs with regard to new problems and re-sensitizing regarding problem solving, strengthening health behaviors and justifying the beneficial effects of actions with regard to improving the index. tangible things, controlling the studied variables, exchanging opinions about the success and failure of the measures taken, explaining the proposed solution with the help of the patient and family. In this stage, follow-up care consultations will be carried out frequently for two months with phone calls according to the care needs of the intervention group. Evaluation stage: The actions of this stage include the evaluation of the desired variables using questionnaires. Finally, this stage ends with completing the questionnaire  at the end of the first month and the end of the second month after the intervention.</i_keyword>
      <i_keyword>Control group: : Familiarization stage: The first step in the continuous care model is familiarization, the purpose of which is mutual recognition (patient, family and teacher) and explanation of the model stages. The actions of this stage include introducing the trainer to the patient and the family, clarifying the trainer's expectations during the study stages, specifying the expectations and expectations of the patient and his family, completing the ethical consideration forms, completing the questionnaire forms after selecting and accepting the patient and the family through the press line. Determining and agreeing on the time of the training sessions, on the phone, and mentioning the goals and how the communication is possible which this process is done in the control stage.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score in Chalder's Fatigue Questionnaire. Timepoint: Completing the fatigue questionnaire form before the intervention (familiarization phase) and at the end of the first month and the end of the second month after the intervention (evaluation phase). Method of measurement: Chalder fatigue questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality score in the Pittsburgh Sleep Quality Questionnaire. Timepoint: Completing the sleep quality questionnaire form before the intervention (familiarization phase) and at the end of the first month and the end of the second month after the intervention (evaluation phase). Method of measurement: Pittsburgh sleep quality questionnaire.</prim_outcome>
      <prim_outcome>Quality of life score in the MًَacNew quality of life questionnaire. Timepoint: Completing the quality of life questionnaire form before the intervention (familiarization phase) and at the end of the first month and the end of the second month after the intervention (evaluation phase). Method of measurement: MacNew Quality of Life 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-27</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezarjarib Ave, Isfahan University of Medical Sciences, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
