<?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>IRCT2015110917059N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Urmia University of Medical Sciences</primary_sponsor>
      <public_title>SMS and reminder cards for improving medication adherence</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between the effectiveness of short message service and reminder cards regarding medication adherence in patients with hypertension: A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>143</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15793</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Using colored bags.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the reminder cards group, cards in four different colors with the content of the medication regimen (30 cards), diet (30 cards), physical activities (30 cards) and blood pressure monitoring (30 cards) will be designed. Patients will be educated about how to properly use the card (every day of every educational content 1 card). So that the end of the first month 120 card will be read by patients , and in the second and third month reading cards will be repeated two more times. The patients will be expected to inform the researchers if they failed to check their blood pressure or have to visit the clinical center again in the duration of the intervention. Also, all the patients will be asked to visit the clinical center on alternate weeks (6 times in total during the 3-month intervention) and have their blood pressure checked for free. Intervention 2: Intervention group 2: The patients in the text messaging group will be sent 6 messages a week. Educational content of text messaging is same to educational content of reminder cards and contains medication regimen, diet, physical activities and blood pressure monitoring. Send messages will continue for 3 months. The patients will be expected to inform the researchers if they failed to check their blood pressure or have to visit the clinical center again in the duration of the intervention. Also, all the patients will be asked to visit the clinical center on alternate weeks (6 times in total during the 3-month intervention) and have their blood pressure checked for free.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masumeh Hemmati Maslakpak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Postal Code: 571478334, Orjhans Street, Resalat Blvd, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3365 9031</telephone>
        <email>hemmatma@yahoo.com</email>
        <affiliation>Urmia Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Major inclusion and exclusion criteria: Uncontrolled hypertension confirmed by doctor; being on medication for hypertension; living in the city of Urmia; having access to a mobile phone in patient or a member of his family; being able to use the text messaging function in patient or a member of his family (reading and composing a text message); not being on medication for prostate in the male patients; and willingness to participate in the study will be entry requirements. The exclusion criteria will be: being hospitalized in the duration of the study, unwillingness to participate further; moving to another city; and loss of contact with the patient through his/her mobile phone.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10, I15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension, Secondary hypertension</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 1: In the reminder cards group, cards in four different colors with the content of the medication regimen (30 cards), diet (30 cards), physical activities (30 cards) and blood pressure monitoring (30 cards) will be designed. Patients will be educated about how to properly use the card (every day of every educational content 1 card). So that the end of the first month 120 card will be read by patients , and in the second and third month reading cards will be repeated two more times. The patients will be expected to inform the researchers if they failed to check their blood pressure or have to visit the clinical center again in the duration of the intervention. Also, all the patients will be asked to visit the clinical center on alternate weeks (6 times in total during the 3-month intervention) and have their blood pressure checked for free.</i_keyword>
      <i_keyword>Intervention group 2: The patients in the text messaging group will be sent 6 messages a week. Educational content of text messaging is same to educational content of reminder cards and contains medication regimen, diet, physical activities and blood pressure monitoring. Send messages will continue for 3 months. The patients will be expected to inform the researchers if they failed to check their blood pressure or have to visit the clinical center again in the duration of the intervention. Also, all the patients will be asked to visit the clinical center on alternate weeks (6 times in total during the 3-month intervention) and have their blood pressure checked for free.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: Two times. Method of measurement: Hill-Bone medication adherence scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypertension. Timepoint: Two times. Method of measurement: Mercury sphygmomanometer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>no</sec_id>
        <issuing_authority>no</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-23</approval_date>
        <contact_name>Urmia Medical University</contact_name>
        <contact_address>Urmia, Seru Road. Pardis Nazlu Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
