<?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>IRCT20171223038022N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-20</date_registration>
      <primary_sponsor>Research Deputy Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-administration of medication program on  level of self-efficacy and medication  adherence</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-administration of medication program on level of self-efficacy and medication   adherence of patients with ischemic heart disease admitted in cardiac unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30270</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The research units according to the sequences  that generated by SPSS software before the start of the study were randomly divided into intervention and control groups. In order to prevent the dissemination of information between the two groups, patients in the same room in two groups will not be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic Heart Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, in the first 24 hours, the nurse will be responsible for providing medications and training of medication administration.This training will include the name of the medication, the dosage, the method and timing of the medication, the cause of medication use and possible side effects for the patient.Brochures for each medication will be provided to patients in order to further training.Immediately after completing this stage, the patient's ability to start the second phase is assessed by the checklist number one and, if it is eligible, will enter the second stage of the program.At this stage (second step), the next 24 hours of the patient's medicine will be placed inside a special box that will be available to the patient and can be locked, and the numbered key is provided to nurses at a special place at the nursing station.Then, according to the trained patient in the first stage, the patient will ask his nurse at the appropriate time. After nurse presence, he will remove the relevant medications from the box and will use it with direct supervision of the nurse and after confirmation of the correctness of the medication taken.If needed, blood pressure, pulse, and other vital signs will be controlled by the nurse before taking the medicine, and the patient will be given appropriate training in this regard.Furthermore, the nurse will provide a checklist for patient that named "used medication checklist" to complete the list after taking the medication.This checklist is designed to ensure that the correct medication is taken at the right time. This checklist is also provided to prevent the medication from being missed or reused because of doubt about the use of the medication and will be seen by the nurse in each shift.If the patient delays the authorization for medication use for 1 hour medication consumption will be reminded and This issue is considered as the first indication of lack of readiness  and if it happen in next time, patient will comeback to first step and will use his medication with nurse help.This process is repeated up to 2 times and if the patient is unable to take medication by himself, he will be excluded from the study.At the end of the 24th hour (second stage), the amount of the ability, competence and adequacy of medication use is assessed by the checklist number 3.If used correctly and on time, these medication at the end of the 24 hour second (according to checklist 3),  the patient's next 48 hours  medication is placed in the patient's personal box and a copy of the key is given to him and the patient will be  responsible for keeping the key to himself and taking Medications and the nurse will be responsible for indirect control by counting the pills.This count will take place at certain hours (6:30 am, 12:30 and 6:30 PM).At this stage, the patient will be required to complete a checklist of consumed medications to prevent any of mentioned problems and the checklist will be controlled by the nurse.Possible errors will be recorded and reported at this stage. Intervention 2: Control group: In the control group, the medications are given to the patients by the nurse, and patients will receive routine drug training during admission and at the time of discharge.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Haji Ali Beigloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus University,End of Shahid Bahonar Blvd ,Vakil Abad 2 ,Vakil Abad</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948988</zip>
        <telephone>+98 936 186 6829</telephone>
        <email>rezahajialibeigloo@yahoo.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Haji Ali Beigloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus University,End of Shahid Bahonar Blvd ,Vakil Abad 2 ,Vakil Abad</address>
        <city>MASHHAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948988</zip>
        <telephone>+98 936 186 6829</telephone>
        <email>rezahajialibeigloo@yahoo.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be alert
Diagnosis of ischemic heart disease is confirmed by clinical signs, ECG and enzyme tests by a cardiologist.
No cognitive or psychological problem according to medical records.
Do not have audible(Complete hearing despite the use of aids) and visual(Ability to read newspaper at a distance of 30 cm with glasses )problems.
Age under the 60 and over 18.
Have at least primary education level.
There is a tendency to take medications by the patient himself.
Predict long-term (at least 6 months) consumption of two or more tablets at the time of discharge.
Having a phone number to make calls after the discharge</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discharge to a nursing home or a rehab center, or wherever that  cause  patient deprivation of self-administration of medication.
Unwillingness to follow-up with telephone after discharge.</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, in the first 24 hours, the nurse will be responsible for providing medications and training of medication administration.This training will include the name of the medication, the dosage, the method and timing of the medication, the cause of medication use and possible side effects for the patient.Brochures for each medication will be provided to patients in order to further training.Immediately after completing this stage, the patient's ability to start the second phase is assessed by the checklist number one and, if it is eligible, will enter the second stage of the program.At this stage (second step), the next 24 hours of the patient's medicine will be placed inside a special box that will be available to the patient and can be locked, and the numbered key is provided to nurses at a special place at the nursing station.Then, according to the trained patient in the first stage, the patient will ask his nurse at the appropriate time. After nurse presence, he will remove the relevant medications from the box and will use it with direct supervision of the nurse and after confirmation of the correctness of the medication taken.If needed, blood pressure, pulse, and other vital signs will be controlled by the nurse before taking the medicine, and the patient will be given appropriate training in this regard.Furthermore, the nurse will provide a checklist for patient that named "used medication checklist" to complete the list after taking the medication.This checklist is designed to ensure that the correct medication is taken at the right time. This checklist is also provided to prevent the medication from being missed or reused because of doubt about the use of the medication and will be seen by the nurse in each shift.If the patient delays the authorization for medication use for 1 hour medication consumption will be reminded and This issue is considered as the first indication of lack of readiness  and if it happen in next time, patient will comeback to first step and will use his medication with nurse help.This process is repeated up to 2 times and if the patient is unable to take medication by himself, he will be excluded from the study.At the end of the 24th hour (second stage), the amount of the ability, competence and adequacy of medication use is assessed by the checklist number 3.If used correctly and on time, these medication at the end of the 24 hour second (according to checklist 3),  the patient's next 48 hours  medication is placed in the patient's personal box and a copy of the key is given to him and the patient will be  responsible for keeping the key to himself and taking Medications and the nurse will be responsible for indirect control by counting the pills.This count will take place at certain hours (6:30 am, 12:30 and 6:30 PM).At this stage, the patient will be required to complete a checklist of consumed medications to prevent any of mentioned problems and the checklist will be controlled by the nurse.Possible errors will be recorded and reported at this stage.</i_keyword>
      <i_keyword>Control group: In the control group, the medications are given to the patients by the nurse, and patients will receive routine drug training during admission and at the time of discharge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-Efficacy For Appropriate Medication Use. Timepoint: At the beginning of the study (before the intervention) and 96 hours after the intervention. Method of measurement: Self-Efficacy For Appropriate Medication Use scale.</prim_outcome>
      <prim_outcome>Level of medication adherence. Timepoint: 1 and 2 weeks after discharge. Method of measurement: Morisky medication adherence scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation level of knowledge. Timepoint: 24 after admission and upon discharge. Method of measurement: Instrument to evaluate the level of knowledge.</sec_outcome>
      <sec_outcome>Assessment of patients' satisfaction with type of medication use. Timepoint: At the time of discharge. Method of measurement: Patients' Satisfaction of type of medication Use scale.</sec_outcome>
      <sec_outcome>Nurses' Satisfaction with self-administration of medication program. Timepoint: At the end of the first, second and third months of study. Method of measurement: The Nurses 'Satisfaction from the implementation of self-administration of drug management program in the hospital instrument.</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>Research Deputy Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-10</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
