<?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>IRCT20210704051777N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-15</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of drug application in polypharmacy  elderly</public_title>
      <acronym></acronym>
      <scientific_title>Examination of the effect of using smartphone application on drug self-efficacy and drug adherence in elderly polypharmacy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the permutation block method, they were divided into control and intervention groups. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks was randomly selected. If the first block, AB, was selected, the first person was assigned to group A and the second person to group B. And this process continued until all the samples were assigned. The characteristic of this method was that the two study groups had equal numbers. All steps were performed using Random Allocation software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Poly pharmacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:they receive a drug application ;the content of this application has been prepared and edited by a geriatric master's degree student and under the supervision of professors of Mashhad University of Medical Sciences. The elderly can use this application to access all their common drugs and increase their information about drugs. All drug descriptions in this application are simple and fluent and can be understood by all ages .This application has visual and textual content about how the drugs function in the elderly body, ways to take medicine, pharmaceutical forms and safe dosage of the drug in the elderly.This application has educational videos about insulin injection, how to use inhalation spray and eye drops, ear and nose.The researcher gives complete training to the elderly to use the application.Then installs the application on the elderly phone and encourages the elderly to use the application with continuous follow-up. This process will continue for 8 weeks.During this period, the elderly can raise their possible problems or any medical questions through the communication link in the application with the researcher, to which the researcher will respond and take appropriate action.At the end of the study, the questionnaire of drug self-efficacy and medication adherence  will be filled out again by the elderly. Intervention 2: Control group:They will receive routine medication training by health center staff.</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:
Part of the information about the main outcome

When:
6 months after the results are published

To whom:
Nurses

Conditions:
In research on the elderly

Where to obtain:
Shokoufehshafiee, shafiees971@mums.ir

How to obtain:
Review in terms of type of research

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najme Valizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3859 1512</telephone>
        <email>valizadehn@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najme Valizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3859 1512</telephone>
        <email>valizadehn@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly people who take more than three drugs a day.
Elderly who have the ability to use smartphones</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Elderly people who get a drug self-efficacy score of ٢٩ or higher at the beginning of the study.
Elderly people who get a high drug adherence score of zero at the beginning of the study.
Elderly who have cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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:they receive a drug application ;the content of this application has been prepared and edited by a geriatric master's degree student and under the supervision of professors of Mashhad University of Medical Sciences. The elderly can use this application to access all their common drugs and increase their information about drugs. All drug descriptions in this application are simple and fluent and can be understood by all ages .This application has visual and textual content about how the drugs function in the elderly body, ways to take medicine, pharmaceutical forms and safe dosage of the drug in the elderly.This application has educational videos about insulin injection, how to use inhalation spray and eye drops, ear and nose.The researcher gives complete training to the elderly to use the application.Then installs the application on the elderly phone and encourages the elderly to use the application with continuous follow-up. This process will continue for 8 weeks.During this period, the elderly can raise their possible problems or any medical questions through the communication link in the application with the researcher, to which the researcher will respond and take appropriate action.At the end of the study, the questionnaire of drug self-efficacy and medication adherence  will be filled out again by the elderly.</i_keyword>
      <i_keyword>Control group:They will receive routine medication training by health center staff</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increase in morriski drug adherence score. Timepoint: 8 weeks after installing the drug application. Method of measurement: Drug Adherence Questionnaire  Moriski.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug self-efficacy. Timepoint: 8 weeks after installing the drug application. Method of measurement: Seams Drug Self-Efficacy 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-02</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
