<?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>IRCT20201006048953N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of home based nurse- led cardiac rehabilitation on patients with myocardial infarction</public_title>
      <acronym>HBCR</acronym>
      <scientific_title>The effect of home based nurse- led cardiac rehabilitation on adherence to therapeutic regiments in patients with myocardial infarction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51604</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Given the four classes (women under 50, women equal to or older than 50, men under 50 and men equal to or older than 50) each class will use a quadruple random block (in each The following four states may occur: (I = Intervention &amp; C = control) 1- (IICC) 2- (ICIC), 3- (ICCI), 4- (CICI), 5- (CCII), 6- (CIIC) The order in which each of the above blocks is placed will be determined by the software, then the cards will be sorted according to the specified order and the entry row (according to the order of entry) and the type of assigned group will be covered. Each person's entry into the study of the assigned group will be determined by removing the cover from each intervention or control group card.
It should be noted that on the cover of each card, a row of cards is written (meaning that this is the second person in the desired category to enter the study) and before opening the cover, another researcher checks the entry row of the person in the floor with the check tables. And then the cover of the card will be opened and the type of individual group (intervention group or control group) will be specified, Blinding description: All participants thought they were involved in the intervention, even though some did not. The researcher sends a written consent and an online questionnaire to all participants and it is explained to them that they participate in the research. After random allocation and selection of the test group, the necessary coordination is done with the test group Placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Myocardial Infraction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cardiac rehabilitation of a guiding nurse at home in 4 sessions with lifestyle modification topics in the field of stress management, healthy nutrition and exercise that is done by the researcher and patients are followed for 3 months and patients' weight and blood  pressure control is done and educational pamphlet in It is at the disposal of the patients. Patients in 4 sessions of one and a half hours at home and through virtual educational topics on heart function, blood pressure and heart attack, the effects of exercise and walking on weight control and better heart function, healthy and unhealthy stress management, DASH diet (including vegetables , Sausages, sprouts, whole grain breads and white meat protein) and instructional videos. Patients walk 30 minutes a day and do health meditation, are followed up electronically within two months of training, and patients' questions are answered during this time. Weight and blood pressure are controlled. At the beginning and end of this course, patients take an online questionnaire of demographic information and adherence to Madanlu treatment. Intervention 2: Control group: They receive only the usual care (Includes medication, doctor visits and tests) after discharge from the  hospital and at the end, an educational pamphlet is provided to the patients.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Parsaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 5، Number 30، Zeinab Alley، Mohry Alley، Valiasr Street، Tehran    t</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1966765664</zip>
        <telephone>+98 21 2201 6435</telephone>
        <email>zohrehparsaeian@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Parsaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 30, 5th Floor, Zeinat Alley, Mohri Alley, Valiasr St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1966765664</zip>
        <telephone>+98 21 2201 6435</telephone>
        <email>zohrehparsaeian@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The definitive diagnosis of myocardial infarction is based on the opinion of a cardiologist for 6-12 months.
Literacy
Speaking Persian
Lack of communication and cognitive problems
No other underlying diseases (except diseases that lead to myocardial infarction),
Resides in Tehran
Age between 40-65 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to respond to a home visit more than once
Acute disease with the need for hospitalization and surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cardiac rehabilitation of a guiding nurse at home in 4 sessions with lifestyle modification topics in the field of stress management, healthy nutrition and exercise that is done by the researcher and patients are followed for 3 months and patients' weight and blood  pressure control is done and educational pamphlet in It is at the disposal of the patients. Patients in 4 sessions of one and a half hours at home and through virtual educational topics on heart function, blood pressure and heart attack, the effects of exercise and walking on weight control and better heart function, healthy and unhealthy stress management, DASH diet (including vegetables , Sausages, sprouts, whole grain breads and white meat protein) and instructional videos. Patients walk 30 minutes a day and do health meditation, are followed up electronically within two months of training, and patients' questions are answered during this time. Weight and blood pressure are controlled. At the beginning and end of this course, patients take an online questionnaire of demographic information and adherence to Madanlu treatment.</i_keyword>
      <i_keyword>Control group: They receive only the usual care (Includes medication, doctor visits and tests) after discharge from the  hospital and at the end, an educational pamphlet is provided to the patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to therapeutic regiments. Timepoint: Beginning of research and after 3 months from the start of research. Method of measurement: Madanlu 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-24</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Floor 5، Number 30، Zeinab Alley، Mohry Alley، Valiasr Street، Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
