<?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>IRCT20240624062232N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-29</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of the caregiver burden reduction interventions on family caregivers of heart surgery patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of the caregiver burden reduction program on the outcomes of family caregivers of patients undergoing coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77592</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Caregivers are assigned to groups based on the randomization sequence that will be generated in advance, which is unpredictable and does not have a clear pattern. To assign samples to 2 groups, a block randomization method with a block size of 4 will be used using the software to generate random numbers in the block method, Blinding description: The general introduction of the studied groups will be done, but participants will be unaware of the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  The electronic content will be provided to the family caregivers from the 5th day after the discharge of the patients, gradually within a period of 1 week. This content includes training in the form of patient care manuals after coronary artery bypass surgery, common post-operative medications, stress management, time management, strategies to improve sleep, caregiver-patient communication skills, caregiver-family communication skills, The use of spirituality and a number of audio and video clips will reduce stress and improve sleep. Also, weekly follow-ups and psychological and educational counseling will be implemented for people if needed. This will continue from the 5th day after discharge to 6 weeks after discharge. Research questionnaires will be completed before and after the implementation of the intervention. Intervention 2: Control group: Two calls will be made by the researcher to the caregivers during the period of time (5 days after discharge to 6 weeks after discharge) to remind them about treatment follow-ups and doctor's visits. Before and after that, research questionnaires will be completed.</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:
Only some parts of the data including primary and secondary outcomes can be shared.

When:
The access period starts 4 months after the results are published

To whom:
Researchers working in medical and academic centers

Conditions:
These data will be used only for research and treatment purposes

Where to obtain:
To receive the data, they can send a message to the following email address and submit their request:
fbeheshtaeen@yahoo.com

How to obtain:
After sending the request email, the applicant must present his documents to the researcher (educational and research purposes). After confirmation by the researcher, the data will be available to them within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Molazem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery college, Namazi Sq, Zand St, Shiraz Town</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>molazemzah@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Beheshtaeen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery college,  Namazi Sq., Zand St., Shiraz Town .</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>fbeheshtaeen@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be the primary caregiver of the patient
Over 18 years of age
Ability to read and write
Ability to understand and speak Persian and express feelings and experiences
Having no prior history of caring for patients undergoing coronary artery bypass graft surgery
Caring for the patient that is candidate for coronary artery bypass graft surgery
Having smart-phone equipped with a virtual social network and the ability to use it
Willing to participate in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Incurable and chronic disease in caregiver
Caring for other chronic physical and mental patients in family
A history of diagnosed mental illness or cognitive problems
Employment as a medical staff
Withdrawal from participation during the study
Death of the patient during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  The electronic content will be provided to the family caregivers from the 5th day after the discharge of the patients, gradually within a period of 1 week. This content includes training in the form of patient care manuals after coronary artery bypass surgery, common post-operative medications, stress management, time management, strategies to improve sleep, caregiver-patient communication skills, caregiver-family communication skills, The use of spirituality and a number of audio and video clips will reduce stress and improve sleep. Also, weekly follow-ups and psychological and educational counseling will be implemented for people if needed. This will continue from the 5th day after discharge to 6 weeks after discharge. Research questionnaires will be completed before and after the implementation of the intervention.</i_keyword>
      <i_keyword>Control group: Two calls will be made by the researcher to the caregivers during the period of time (5 days after discharge to 6 weeks after discharge) to remind them about treatment follow-ups and doctor's visits. Before and after that, research questionnaires will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care burden. Timepoint: Five day after discharge (before intervention) and six weeks after discharge (after intervention). Method of measurement: Novak Caregiver Burden Inventory.</prim_outcome>
      <prim_outcome>General health. Timepoint: Five day after discharge (before intervention) and six weeks after discharge (after intervention). Method of measurement: Goldberg General Health Questionnairre.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Carer quality of life. Timepoint: Five day after discharge (before intervention) and six weeks after discharge (after intervention). Method of measurement: Adult Carer Quality of Life 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-17</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street, Namazi Sq. Nursing and midwifery college Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
