<?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>IRCT20210303050562N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of telephone counseling on patients with coronary angioplasty</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of telephone counseling based on Orem model on adherence to treatment and resilience of patients with coronary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55950</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Initially, 80 patients with coronary angioplasty will be selected from among eligible individuals. Then, patients are divided into experimental and control groups based on a random quadruple block prepared using block generation software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, in addition to educational pamphlets and routine hospital care, telephone counseling will be provided for 2 months after discharge. Each patient will receive a mobile and home number, as well as the mobile number of a family member, and the patient will be given the researcher's mobile number. They will be provided with a schedule of telephone calls, which includes 3 calls per week for 2 months. The average call time will be 30 minutes. The call time range is from 8 am to 9 pm Also, if you have a problem or have a question, contact the researcher within the same time frame. The patient will be referred to a physician to follow up on patients' questions and problems if needed In the first telephone call, the client's needs are assessed using the Orem Needs Assessment Questionnaire, which includes three basic categories (general self-care needs, care needs for growth and development, self-care needs when deviating from health). To take. Then, based on the needs assessment, patients are evaluated and determined from three aspects in the field of nursing diagnosis, including: 1. Self-care treatment needs (which patient needs are met and which needs are not met, and what factors cause the needs to be met) ، 2. Self-care agent (patient's potential self-care abilities) 3. Decreased self-care (where the patient is weak and unable to take care of himself).In the next stage, the care plan will be designed and developed based on the goals in the form of educational-supportive nursing system, which includes: a- meeting the patient's needs in self-care b- making the patient responsible for self-care c- increasing the patient's independence in His care and adaptation to the changes that have been made and ... is. In fact, the role of the nurse in the education-support system of Orem is more of a counseling mode. For example, a heart patient with high blood cholesterol, a nurse with training on a healthy diet, including: (reducing the consumption of saturated fats (animal fats) and replacing them with unsaturated fats (vegetable oils), consuming omega-3 oils, reducing consumption Salt, weight loss, more consumption of fruits and vegetables, etc.) helps the patient to achieve self-care by increasing awareness of their diet. Also, the heart patient who has undergone angioplasty and his self-confidence has decreased due to limitations, the nurse helps the patient to trust in his / her abilities against the disease by focusing on the patient's abilities, strengthening positive behaviors and improving the patient's behavioral and mental performance in order to adapt to the disease. Feel good despite the limitations. At this stage, the planned nursing measures will be implemented in the form of supportive counseling, and finally the evaluation will be done based on the goals of reducing needs and increasing abilities through telephone calls and repetition and practice. The content of telephone calls generally includes the following: 1. Introduce yourself and ask questions about the patient's general health status 2. Giving health advice and education related to nutrition and medicine 3. Patient adherence to diet, medication, activity and exercise 4. Enhancing patient health behaviors and agreed behavioral goals. Strengthen disease acceptance and patient adaptation to conditions 6. End the call using incentive sentences and determine the time of the next call. Intervention 2: Control group: do not receive telephone counseling over the phone, and educational pamphlets and standard hospital care include: (education about diet, activity, medications, and presentation of educational pamphlets about illness and medication) as well as how to see a doctor at the time of discharge will be provided.</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 At the end of the study, if necessary, the coded data will be published along with the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khatereh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Namazi Square, Zand st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>khaterehrostami61@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khatereh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Namazi Square, Zand st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>khaterehrostami61@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>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No known severe mental illness
Ability to communicate and no hearing or speech problems
Mobile or landline access and knowledge of its use
Literacy for reading and writing
Age 18 to 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Incomplete completion of questionnaires
Failure to implement the intervention program completely
Participate in a similar care program in the last 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the experimental group, in addition to educational pamphlets and routine hospital care, telephone counseling will be provided for 2 months after discharge. Each patient will receive a mobile and home number, as well as the mobile number of a family member, and the patient will be given the researcher's mobile number. They will be provided with a schedule of telephone calls, which includes 3 calls per week for 2 months. The average call time will be 30 minutes. The call time range is from 8 am to 9 pm Also, if you have a problem or have a question, contact the researcher within the same time frame. The patient will be referred to a physician to follow up on patients' questions and problems if needed In the first telephone call, the client's needs are assessed using the Orem Needs Assessment Questionnaire, which includes three basic categories (general self-care needs, care needs for growth and development, self-care needs when deviating from health). To take. Then, based on the needs assessment, patients are evaluated and determined from three aspects in the field of nursing diagnosis, including: 1. Self-care treatment needs (which patient needs are met and which needs are not met, and what factors cause the needs to be met) ، 2. Self-care agent (patient's potential self-care abilities) 3. Decreased self-care (where the patient is weak and unable to take care of himself).In the next stage, the care plan will be designed and developed based on the goals in the form of educational-supportive nursing system, which includes: a- meeting the patient's needs in self-care b- making the patient responsible for self-care c- increasing the patient's independence in His care and adaptation to the changes that have been made and ... is. In fact, the role of the nurse in the education-support system of Orem is more of a counseling mode. For example, a heart patient with high blood cholesterol, a nurse with training on a healthy diet, including: (reducing the consumption of saturated fats (animal fats) and replacing them with unsaturated fats (vegetable oils), consuming omega-3 oils, reducing consumption Salt, weight loss, more consumption of fruits and vegetables, etc.) helps the patient to achieve self-care by increasing awareness of their diet. Also, the heart patient who has undergone angioplasty and his self-confidence has decreased due to limitations, the nurse helps the patient to trust in his / her abilities against the disease by focusing on the patient's abilities, strengthening positive behaviors and improving the patient's behavioral and mental performance in order to adapt to the disease. Feel good despite the limitations. At this stage, the planned nursing measures will be implemented in the form of supportive counseling, and finally the evaluation will be done based on the goals of reducing needs and increasing abilities through telephone calls and repetition and practice. The content of telephone calls generally includes the following: 1. Introduce yourself and ask questions about the patient's general health status 2. Giving health advice and education related to nutrition and medicine 3. Patient adherence to diet, medication, activity and exercise 4. Enhancing patient health behaviors and agreed behavioral goals. Strengthen disease acceptance and patient adaptation to conditions 6. End the call using incentive sentences and determine the time of the next call.</i_keyword>
      <i_keyword>Control group: do not receive telephone counseling over the phone, and educational pamphlets and standard hospital care include: (education about diet, activity, medications, and presentation of educational pamphlets about illness and medication) as well as how to see a doctor at the time of discharge will be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Questionnaire of adherence to treatment of chronic patients Madanloo 1392.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Resilience questionnaire for Ebadi heart and respiratory patients 2016.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-27</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, 7th floor, shiraz university of medical science, zand st. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
