<?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>IRCT20220814055689N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the impact of  planned behavior theory oriented intervention on drug adherence</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the impact of  planned behavior theory oriented intervention on drug adherence in patients undergoing coronary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using Excel software, 22 blocks of four are formed and in each block, the cells are randomly assigned between control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary Angioplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At the patient's first visit to the clinic, after registering their information in the demographic questionnaire, the level and proportion of medication adherence are measured through the utilization of the Moriski questionnaire and the Global evaluation of medication adherence tool.Then, if desired medication adherence is not achieved, with the cooperation of the patient, barriers to medication use in terms of time and place of medication use and method of use are identified, and a practical plan to cope with these barriers is developed based on each patient's problems.                                                                A written copy of this plan along with an educational brochure is given to the patient. The importance of proper medication use is also orally taught and a educational  brochure is given to patients who have desirable medication adherence. Then, during a 30-days period, this program is executed by phone or in-person reminders to the patient and after 60 days, the level and proportion of medication adherence are measured again. Additionally, during this stage, the rate of re-hospitalization of patients, within a two-month period of program implementation is measured. It should be noted that this intervention focuses on adherence to antiplatelet, statin and aspirin medications. Intervention 2: Control group: In this group, the rate and ratio of drug compliance is measured in the first visit and then common trainings after angioplasty are provided. Again, 60 days later, the rate and ratio of drug compliance will be measured. After the final evaluation, educational pamphlets will be given to the patients of the control group.</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:
The demographic profile file of the participants, dependent and independent variables, data classification system, codes used in the analysis, clinical study report, informed consent form, statistical analysis map will be shared through the faculty website and email after the study is done.

When:
There is no limitation.

To whom:
Researchers

Conditions:
For future research and meta-analysis

Where to obtain:
Researcher's email

How to obtain:
The request should be sent to email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DR.Elham Navab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery, Nosrat Ave,Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>elhamnavab2@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR Elham Navab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery, Nosrat Ave.,Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>elhamnavab2@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of coronary angioplasty
Positive behavioral intention to take medicine
Absence of underlying chronic non-cardiac disease that affects the quality of life.
Physical and cognitive ability and independence of medication use.
Age requirement:18 to 75 years
Literacy for reading and writing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of mental health
Diseases or surgeries that require not taking anti-platelet drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of coronary angioplasty implant and graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At the patient's first visit to the clinic, after registering their information in the demographic questionnaire, the level and proportion of medication adherence are measured through the utilization of the Moriski questionnaire and the Global evaluation of medication adherence tool.Then, if desired medication adherence is not achieved, with the cooperation of the patient, barriers to medication use in terms of time and place of medication use and method of use are identified, and a practical plan to cope with these barriers is developed based on each patient's problems.                                                                A written copy of this plan along with an educational brochure is given to the patient. The importance of proper medication use is also orally taught and a educational  brochure is given to patients who have desirable medication adherence. Then, during a 30-days period, this program is executed by phone or in-person reminders to the patient and after 60 days, the level and proportion of medication adherence are measured again. Additionally, during this stage, the rate of re-hospitalization of patients, within a two-month period of program implementation is measured. It should be noted that this intervention focuses on adherence to antiplatelet, statin and aspirin medications.</i_keyword>
      <i_keyword>Control group: In this group, the rate and ratio of drug compliance is measured in the first visit and then common trainings after angioplasty are provided. Again, 60 days later, the rate and ratio of drug compliance will be measured. After the final evaluation, educational pamphlets will be given to the patients of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of drug adherence after coronary angioplasty. Timepoint: Prior to intervention, 30 days after intervention, and 60 days after intervention. Method of measurement: The determination of medication adherence level using the Morisky Medication Adherence Scale,.</prim_outcome>
      <prim_outcome>The ratio of drug adherence after coronary angioplasty. Timepoint: Prior to intervention, 30 days after intervention, and 60 days after intervention. Method of measurement: measuring the ratio of medication adherence using the Brazilian Global Evaluation of Medication Adherence (GEMA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of readmission of patients. Timepoint: 60 days after intervention. Method of measurement: Patient information questionnaire.</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>2022-10-24</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - TUMS</contact_name>
        <contact_address>Room 604, 6th Floor, Tehran University of Medical Sciences Central Building, Qods Intersection, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
