<?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>IRCT20160503027736N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-04</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study of using drug reminder cards with telephone follow-up on drug adherence of the elderly with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of using drug reminder cards with telephone follow-up on drug adherence of the elderly with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64329</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, include gender and scores of Morisky medication adherence scale-8. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables. The following table is used as a randomization tool: 

Variables Category  : Intervention group (pill card)  * Intervention group 
(phone call)*Control group

morrisky medication adherence scale-8(MMAS-8)
score
A score of 0 to 6 is adherence
Score 8 to 6
Moderate  adherence
A score 8 high adherence

sex:    female      male.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Drug adherence in the elderly with high blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Medication reminder card، Weekly drug reminder cards are designed by the researcher and given to the patient according to the review of the available texts and booklets and based on the drugs used by the patient. Considering that the intervention lasts for 3 months, 12 cards are designed for each person over time and according to the changes in the drugs used. The information on these cards includes the name of the drug, a clear color picture of the pill, the number of pills per dose, the reason for using it with a color picture (for example, the picture of a sphygmomanometer for antihypertensive medicine), the time/time of using the medicine using the picture or The pictograph will be the time of day and night (morning, noon, night, bedtime). Two copies of each reminder card are given to the patient and it is recommended to place each one in the most visible places. (For example, on the refrigerator door, inside the bedroom or on the prayer mat...). Intervention 2: Intervention group: Telephone call group.The researcher keeps track of how the drugs are taken through phone calls. In this way, the nurse calls all the people at the pre-arranged time and reminds them of the name of the medicine, the dose of the medicine, the time of taking the medicine and the considerations when taking the medicine. The duration of the conversation is considered to be 5 to 10 minutes on average for each person, which varies based on the needs and educational questions of the patients. The phone call time will be set between 8:00 am and 8:00 pm with the agreement of the patients. The call schedule is provided to the patient in writing. The number of phone calls to follow up adherence to medication will be 2 times a week in the first month and once a week during the second and third months. If the first call is missed, the second call will be made on the same day. If the second call is also missed, the last call will be made the next day. Telephone follow-up is done for 3 months based on studies (33, 34). Telephone conversations will be recorded in the set form. Intervention 3: Control group: In the control group, routine blood pressure treatment activities and care will be performed according to the routine of comprehensive health service centers.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Mazhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Nurse St., Gomohri-e-Islami Blvd</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>f.mazhari@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahin Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Complex, Alley No. 5, Muftah Blvd</address>
        <city>Rafsanjan</city>
        <country1>Central African Republic</country1>
        <zip>7718796755</zip>
        <telephone>+98 913 290 7256</telephone>
        <email>sh.heidari@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Seniors 60 to 75 years old
suffering from high blood pressure according to the doctor's opinion
taking antihypertensive drugs
being able to read and write
not suffering from Alzheimer's and other types of dementia
physical ability (movement-vision-hearing) to take medicines independently
Not using other types of drug reminders</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>being admitted to the hospital
Change of mental state and alertness of a person due to a disease such as CVA
Unwillingness to continue participating in the study
Failure  to answer the phone more than twice
Failure to attend the health center once a month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Medication reminder card، Weekly drug reminder cards are designed by the researcher and given to the patient according to the review of the available texts and booklets and based on the drugs used by the patient. Considering that the intervention lasts for 3 months, 12 cards are designed for each person over time and according to the changes in the drugs used. The information on these cards includes the name of the drug, a clear color picture of the pill, the number of pills per dose, the reason for using it with a color picture (for example, the picture of a sphygmomanometer for antihypertensive medicine), the time/time of using the medicine using the picture or The pictograph will be the time of day and night (morning, noon, night, bedtime). Two copies of each reminder card are given to the patient and it is recommended to place each one in the most visible places. (For example, on the refrigerator door, inside the bedroom or on the prayer mat...)</i_keyword>
      <i_keyword>Intervention group: Telephone call group.The researcher keeps track of how the drugs are taken through phone calls. In this way, the nurse calls all the people at the pre-arranged time and reminds them of the name of the medicine, the dose of the medicine, the time of taking the medicine and the considerations when taking the medicine. The duration of the conversation is considered to be 5 to 10 minutes on average for each person, which varies based on the needs and educational questions of the patients. The phone call time will be set between 8:00 am and 8:00 pm with the agreement of the patients. The call schedule is provided to the patient in writing. The number of phone calls to follow up adherence to medication will be 2 times a week in the first month and once a week during the second and third months. If the first call is missed, the second call will be made on the same day. If the second call is also missed, the last call will be made the next day. Telephone follow-up is done for 3 months based on studies (33, 34). Telephone conversations will be recorded in the set form.</i_keyword>
      <i_keyword>Control group: In the control group, routine blood pressure treatment activities and care will be performed according to the routine of comprehensive health service centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Drug adherence in the elderly with high blood pressure. Timepoint: At the beginning of sample collection, one, two, three months after the start of the intervention. Method of measurement: Morisky medication adherence questionnaire, demographic information questionnaire, pill counting form.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-22</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Nurse Street, College of Nursing and Midwifery Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
