<?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>IRCT20180911041002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-22</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  patient education and follow up with short massage on patient's therapeutic adherence with heart disease.</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effect of  patient education and follow up with short massage  on adherence to therapeutic regimen of the patients with acute coronary syndrome after discharge of coronary care units.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>111</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33805</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: We have three groups in this study. Group A = training with booklet, Group B = training with booklet and follow-up with SMS, and Group C = Control group.
In this study, we have 111 samples, each of which contains 37 patients. For block randomization, the simplest and smallest production block will be 3 blocks (3 = the number of groups under investigation). Therefore, we have 6 states including 1. ABC, 2. CAB, 3. CAB, 4. BCA, 5. BAC, 6. ABC. To execute, we will use a regular hexagon (6 sided dice) that each side of dice is attributed to one of the 1 to 6 above states. So, by each throwing a dice, one of these situations arises. By 37 throwing the dice, we have  37 triple block that randomly created.  Example:
ABC, BAC, BAC, CBA, ABS, CAB, ........ = 37 Triple Block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Coronary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group will be educated about adherence the drug orders, the type of medications used by the patient, the importance of adherence of medication orders, unwanted side effects of drugs, considering doses of medication, taking on time, emergency medicines, diet and permitted exercise. The second group: In addition to teaching the above, short message will be sent about the times and drug using, attention to dosage, diet, and mobility are at the acceptable level. These training take place in two sessions and each session about 45 minutes. Intervention 2: Second intervention group: training, booklet, Follow-up reminder short messages Patients are trained in the ward on the patient's bedside for a half to an hour before discharge by the researcher. The booklet has been prepared by a researcher and confirmed by a cardiologist and dietitian. Within two months after the discharge, 3 times a week, a reminder message will be sent to the patient. Two months after discharge the adherence questionnaire, researcher at the Patient's Home or Heart Clinic will complete the face-to-face interview. Intervention 3: Control group will receive only routine training before discharge of the ward. Two months after discharge of the patients, they will complete the adherence questionnaire in their home or in clinical heart disease department through face-to-face interview by researcher.</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:
Results of the study will be published as an article. The ethical principle will be respected during preparation of the article for publishing.

When:
Accessibility of the data can be started 6 months after publishing the results of the study as an article.

To whom:
Only for researchers working in academic and scientific institutions.

Conditions:
The results could be used for scientific purposes with citing to the article published.

Where to obtain:
4918936316 TEL_01732451660 Fax_4421657, Golestan University of Medical Sciences, Sari Road, Gorgan, IRAN

How to obtain:
Scholar valid documents and the title of study must be sent and the study must be about adherence of therapeutic regime in patient with acute coronary syndrome.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholam Reza Mahmoodi-shan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Sari Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 17324551660</telephone>
        <email>mahmoodigh@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zoleikha Ghoreishi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Sari Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4918936316</zip>
        <telephone>+98 17324551660</telephone>
        <email>ghoreishi.z@goums.ac.ir</email>
        <affiliation>Gorgan 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>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 25 to 75 years old
Acute coronary syndrome diagnosis approved by a cardiologist physician
Ability to speak and understanding Persian language by patient or relatives
Ability to using mobile by patient or relatives
Having active mobile and ability to send SMS by patient or relatives
Achieving adherence score less than 50%</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having other advanced disease, such as cancer, diabetes
Not having diagnosed mental disorder
Unwillingness to participate in research by patient or relatives
Lack of access to the patient after discharge</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute ischaemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group will be educated about adherence the drug orders, the type of medications used by the patient, the importance of adherence of medication orders, unwanted side effects of drugs, considering doses of medication, taking on time, emergency medicines, diet and permitted exercise. The second group: In addition to teaching the above, short message will be sent about the times and drug using, attention to dosage, diet, and mobility are at the acceptable level. These training take place in two sessions and each session about 45 minutes.</i_keyword>
      <i_keyword>Second intervention group: training, booklet, Follow-up reminder short messages Patients are trained in the ward on the patient's bedside for a half to an hour before discharge by the researcher. The booklet has been prepared by a researcher and confirmed by a cardiologist and dietitian. Within two months after the discharge, 3 times a week, a reminder message will be sent to the patient. Two months after discharge the adherence questionnaire, researcher at the Patient's Home or Heart Clinic will complete the face-to-face interview.</i_keyword>
      <i_keyword>Control group will receive only routine training before discharge of the ward. Two months after discharge of the patients, they will complete the adherence questionnaire in their home or in clinical heart disease department through face-to-face interview by researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to the treatment regimen. Timepoint: At the beginning of the study and 2 months after the patient's discharge. Method of measurement: Adherence to treatment questionnaire-self report.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-03</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Golestan University of Medical Sciences, Shast-Kola Road, Saari Road, Gorgan Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
