<?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>IRCT20190917044802N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-17</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The effect of discharge plan training based on Orem self-care model on hope and adherence to treatment in patients undergoing coronary angioplasty</public_title>
      <acronym></acronym>
      <scientific_title>The effect of discharge plan training based on Orem self-care model on hope and adherence to treatment in patients undergoing coronary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64499</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The allocation of the sample in the intervention and control group is randomly simple, as in a 90-card envelope with the letters A written on 45 cards and the letters B on the other 45 cards. Patients who meet the inclusion criteria are asked to pick up a card, if they pick up card A they will be in the intervention group and if they pick up card B they will be in the control group and this process will continue until the sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The training program based on Orem's self-care model will be designed and implemented in 6 sessions. One-hour classes will be held in the form of group discussions and lectures with educational pamphlets. It is worth mentioning that all phone calls to follow up on the condition of the patients will be made by the researcher and phone follow-up will be done for 3 months. In each session, in addition to teaching, the patient's medications will also be checked and the status of the patients' compliance with the treatment will be checked and the patients They will be encouraged to cooperate more. Also, the factors that prevent adherence and adherence to the treatment of patients are identified and measures are taken to eliminate them. In the first session, the structure of the sessions and the goals of the educational program will be introduced, and hope will be defined based on Schneider's theory, and necessary explanations will be given about the complications and prognosis of the disease to improve lifestyle. Its impact on health is discussed. In addition, in these two sessions, we try to establish the necessary therapeutic relationship with each of the clients, and the processes and dynamics of the group are taken into consideration. The use of proper nutrition is recommended to improve the lifestyle. In the third session, each client is asked to tell his life story in his own language to the group, and these stories are explained based on the three main components of Schneider's theory: the goal, the agent, and the passages. and will be formatted. In this meeting, we try to identify and pay attention to the issues of hope in the life of each member, and in order to improve the lifestyle of the patients, we inform them about the drugs, how to take them, and the possible side effects of the drugs. In the fourth session, the members are asked to provide a list of current events and important aspects of their lives and to determine the importance of each of them. And we encourage patients to exercise, physical activity and appropriate physical activities to improve their lifestyle. In the fifth session, the characteristics of appropriate goals are presented, then people are encouraged to set goals in each of the areas of life, and patients In order to improve the lifestyle, we introduce risk factors such as obesity, smoking, inactivity, stress, anxiety and tension and any other factors that are harmful for patients. In the sixth and last session, people are asked to achieve the set goals. Find suitable solutions. In order to improve the patients' lifestyle, they are explained to visit their doctor every 1 to 3 months for re-examination and paraclinical procedures. Intervention 2: Control group: The control group will not receive training intervention, but will be provided with a training package.</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:
After completing the study and publishing the results, by requesting the use of the study process and the use of questionnaires, as well as the content of the training program, the author in charge of the documentation will be shared.

When:
It has no time limit

To whom:
For researchers working in academic and scientific institutions

Conditions:
After completing the study and publishing the results, by requesting the use of the study process and the use of questionnaires, as well as the content of the training program, the author in charge of the documentation will be shared.

Where to obtain:
Request to the responsible author via email

How to obtain:
Send a request to use the documents to the responsible author via email and send the documents requested by the responsible author to the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Bizhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Square. Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 21 5335 0994</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Bizhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Square. Fasa University of Medical Sciences</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 21 5335 0994</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be literate
No mental problem
Minimum age 40 years and maximum age 55 years
Willingness to participate in the study voluntarily</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>being illiterate
Having heart, kidney, lung and liver failure
Suffering from acute and chronic psychological disorder and intellectual disability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>121</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The training program based on Orem's self-care model will be designed and implemented in 6 sessions. One-hour classes will be held in the form of group discussions and lectures with educational pamphlets. It is worth mentioning that all phone calls to follow up on the condition of the patients will be made by the researcher and phone follow-up will be done for 3 months. In each session, in addition to teaching, the patient's medications will also be checked and the status of the patients' compliance with the treatment will be checked and the patients They will be encouraged to cooperate more. Also, the factors that prevent adherence and adherence to the treatment of patients are identified and measures are taken to eliminate them. In the first session, the structure of the sessions and the goals of the educational program will be introduced, and hope will be defined based on Schneider's theory, and necessary explanations will be given about the complications and prognosis of the disease to improve lifestyle. Its impact on health is discussed. In addition, in these two sessions, we try to establish the necessary therapeutic relationship with each of the clients, and the processes and dynamics of the group are taken into consideration. The use of proper nutrition is recommended to improve the lifestyle. In the third session, each client is asked to tell his life story in his own language to the group, and these stories are explained based on the three main components of Schneider's theory: the goal, the agent, and the passages. and will be formatted. In this meeting, we try to identify and pay attention to the issues of hope in the life of each member, and in order to improve the lifestyle of the patients, we inform them about the drugs, how to take them, and the possible side effects of the drugs. In the fourth session, the members are asked to provide a list of current events and important aspects of their lives and to determine the importance of each of them. And we encourage patients to exercise, physical activity and appropriate physical activities to improve their lifestyle. In the fifth session, the characteristics of appropriate goals are presented, then people are encouraged to set goals in each of the areas of life, and patients In order to improve the lifestyle, we introduce risk factors such as obesity, smoking, inactivity, stress, anxiety and tension and any other factors that are harmful for patients. In the sixth and last session, people are asked to achieve the set goals. Find suitable solutions. In order to improve the patients' lifestyle, they are explained to visit their doctor every 1 to 3 months for re-examination and paraclinical procedures.</i_keyword>
      <i_keyword>Control group: The control group will not receive training intervention, but will be provided with a training package</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hope. Timepoint: Before, immediately and three months after the educational intervention. Method of measurement: Snyder Hope Questionnaire.</prim_outcome>
      <prim_outcome>Life Style. Timepoint: Before, immediately and three months after the educational intervention. Method of measurement: Walker Health Promoting Lifestyle Questionnaire.</prim_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: Before, immediately and three months after the educational intervention. Method of measurement: Treatment Adherence 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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-26</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Square. Fasa University of Medical Sciences Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
