<?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>IRCT20180513039646N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the family-centered educational program on medication management and quality of life in elderly patients with ischemic heart disease.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the family-centered educational program on medication management and quality of life in elderly patients with ischemic heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31547</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Initially, in both groups of patients with ischemic heart disease in research clinics with follow-up records, demographic and disease inventory, drug management tools and elite life quality of LEIPAD will be completed. In this study, the control group Only the clinic's usual education will be received and in the family-based training group, the training will be in the form of three sessions of training, 40-30 minutes, to the patient and the active member of the family. Clinical classroom sessions in groups of 3 to 6 (from each patient with an active member of the family at a meeting) will be agreed upon at the hour. It should be noted that at the end of this step, in order to comply with the ethics of the educational pamphlet, it will also be presented, Randomization description: Sampling is done in two steps, so that in the first step, random sampling is done using a random number table from the patient list to the sample size. In the second step, the samples are randomly allocated by blocking method in two groups of test and control (design of permutation blocks with two treatments). Given the letter "A" for the intervention group and the letter "B" for the control group, then all the permutation combinations that have six different combinations are written and for each permutation of one of the digits 1 to 6 (For example, a, b, b for digit 1, a, b, a, for digit 2, etc.). Then, from digits 1 through 6, a digit is selected randomly, and we continue to do this until the sample size reaches the quantification.</study_design>
      <phase>3</phase>
      <hc_freetext>Ischemic Heart Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the intervention group, family-centered education will be provided to the patient and active member of the family in the form of three sessions of 40-30 minutes. Clinical classroom sessions in groups of 3 to 6 (from each patient with an active member of the family at a meeting) will be agreed upon at the hour, so that the first session includes the referencing and expression of the voluntary nature of the research, and Clarifying the researcher's expectations at different stages of the study, as well as identifying the expectations and expectations of the patients and their active members of the family, determining and agreeing on the length of the appointment or telephone appointment (the phone will be used only for essential reminders and conversations) and the purpose And the second session also includes the definition of ischemic heart disease, its types and the explanation of pathophysiology Xi concise and understandable for the patient, symptoms, risk, clinical protests. The third session includes an explanation of the various therapeutic and pharmaceutical approaches, the types of drugs in these diseases and important points during their use, the care and helpful strategies to improve the lifestyle of the elderly, such as diet, activity and stress control The way of self-care and the importance of maintaining mental, social and sexual performance. It should be noted that at the end of this step, in order to comply with the ethics of the educational pamphlet, it will also be presented. Intervention 2: Control group: the control group will receive only the usual training of the clinic.</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:
-

When:
-

To whom:
-

Conditions:
-

Where to obtain:
-

How to obtain:
-

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Sadat Hejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Nursing and Midwifery Faculty, East Nusrat St, Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>zahra.s.hejazi@hotmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Tabari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Nursing and Midwifery Faculty, East Nusrat St,Tohid Square,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>ftabari@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Reading and writing literacy (for patient or family member)
Age between 60 and 75 years
The absence of diagnosed psychological illness
Ischemic Heart Disease Detected by Heart Disease
At least 6 months have passed since the diagnosis of the disease and has a sustained pain and hemodynamic status
A positive response to two or more questions is the "HbL Drug Dangers Questionnaire" that is used to assess the problems associated with drug use in the elderly.
Residence of an active member of the family at or near the patient's place of residence</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Entry into the acute phase of the disease
The company participated simultaneously in other similar specialized studies
Having even a session absent in the classroom for a patient or family member
Unwillingness (patient and active member of the family) to continue participating in the study or death of a sick person or an active member of the family
Do not answer phone at least for two times</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease, unspecified</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: in the intervention group, family-centered education will be provided to the patient and active member of the family in the form of three sessions of 40-30 minutes. Clinical classroom sessions in groups of 3 to 6 (from each patient with an active member of the family at a meeting) will be agreed upon at the hour, so that the first session includes the referencing and expression of the voluntary nature of the research, and Clarifying the researcher's expectations at different stages of the study, as well as identifying the expectations and expectations of the patients and their active members of the family, determining and agreeing on the length of the appointment or telephone appointment (the phone will be used only for essential reminders and conversations) and the purpose And the second session also includes the definition of ischemic heart disease, its types and the explanation of pathophysiology Xi concise and understandable for the patient, symptoms, risk, clinical protests. The third session includes an explanation of the various therapeutic and pharmaceutical approaches, the types of drugs in these diseases and important points during their use, the care and helpful strategies to improve the lifestyle of the elderly, such as diet, activity and stress control The way of self-care and the importance of maintaining mental, social and sexual performance. It should be noted that at the end of this step, in order to comply with the ethics of the educational pamphlet, it will also be presented.</i_keyword>
      <i_keyword>Control group: the control group will receive only the usual training of the clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life: It is the individual's thoughts of his or her living conditions, according to the culture and value system in which they live, and the relation of these receipts to their goals, expectations, expectations, standards and priorities. Pharmaceutical Management: Includes patient-focused care that optimizes safe, effective, and effective drug treatment, and is provided through collaboration with patients and their care team. Timepoint: These variables are measured at the beginning of the study and three months after the intervention. Method of measurement: The quality of life in this study is a score that a person earns based on the LEIPAD 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-10</approval_date>
        <contact_name>Committee on Ethics in the Research of Nursing Midwifery and Rehabilitation Faculty of Tehran Univer</contact_name>
        <contact_address>Towhid Square, Dr Mirkhani Street (Eastern Nusrat), Faculty of Nursing, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
