xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05999279</url>
    </required_header>
    <id_info>
      <org_study_id>12/23/D</org_study_id>
      <nct_id>NCT05999279</nct_id>
    </id_info>
    <brief_title>Patient Preferences With Pharmaceutical Care: In-person Versus Digital Health</brief_title>
    <official_title>A Cross-sectional Study Addressing Lebanese Patient Preferences With Pharmaceutical Care: Traditional Versus Digital Health?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lebanese University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lebanese University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Digital pharmaceutical care, also known as e-pharmaceutical care or telepharmacy, refers to&#xD;
        using digital technologies to provide remote pharmaceutical care services. It involves the&#xD;
        application of digital tools and platforms to deliver medication-related services, patient&#xD;
        counseling, medication management, and other pharmaceutical care activities. It allows&#xD;
        patients to access pharmaceutical services conveniently from their homes or any location with&#xD;
        an internet connection. This is particularly beneficial for individuals with limited&#xD;
        mobility, those living in rural or underserved areas, or patients with difficulty visiting a&#xD;
        physical pharmacy. However, it is essential to note that while digital pharmaceutical care&#xD;
        provides many benefits, it may only suit some patients or situations. Some individuals may&#xD;
        still prefer face-to-face interactions or may require hands-on assistance, especially for&#xD;
        complex medication management. Healthcare providers should assess the appropriateness of&#xD;
        digital solutions on a case-by-case basis and ensure patient privacy and data security when&#xD;
        implementing digital pharmaceutical care services.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Patient preference</measure>
      <time_frame>through study completion, an average of 2 months</time_frame>
      <description>A self-reported questionnaire was developed and piloted on the first 30 patients visiting the pharmacies. Minor modifications were performed taking into consideration two expert reviews. It is available in Arabic (native language) and English based on participants' preferences. It includes 3 parts: the first part comprises the baseline characteristics of the patients and their medical history/habits; the second part reports patients' preferences, benefits and disadvantages of each of the outcomes (in-person versus digital health); and the third part assess e-literacy among them using the e-HEALS 8-item scale previously validated on the Arab population.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">386</enrollment>
    <condition>Patient Preference</condition>
    <arm_group>
      <arm_group_label>Patient</arm_group_label>
      <description>Convenient sampling of patients who took at least one medication in the past month</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Survey</intervention_name>
      <description>Developed questionnaire to assess the literacy of patients + another survey to assess their preferences regarding traditional versus digital pharmaceutical care</description>
      <arm_group_label>Patient</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult individuals who visited two community pharmacies during the data collection period.&#xD;
          No criteria were based on sex, race, nationality, or ethnicity.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who took at least one medication in the past month&#xD;
  &#xD;
            -  Patient visiting two community pharmacies&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those refusing to participate&#xD;
  &#xD;
            -  Those with severe hearing or mental problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Georges Hatem, PhD</last_name>
      <phone>+351914091047</phone>
      <email>georges.r.hatem@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sanaa Awada, PhD</last_name>
      <phone>+9615463375</phone>
      <email>sanaa3a@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pharmacy Bouchi</name>
        <address>
          <city>Beirut</city>
          <state>Mount Lebanon</state>
          <zip>0000</zip>
          <country>Lebanon</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Georges Hatem, PhD</last_name>
        <phone>+9615463375</phone>
        <email>georges.r.hatem@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Tatiana Abou Zeid</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Pharmacy du Liban</name>
        <address>
          <city>Beirut</city>
          <zip>0000</zip>
          <country>Lebanon</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sanaa Awada, PhD</last_name>
        <phone>+9615463375</phone>
        <email>sanaa3a@hotmail.com</email>
      </contact>
      <investigator>
        <last_name>Sarah Khalil, PharmD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Lebanon</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Lebanese University</investigator_affiliation>
      <investigator_full_name>Georges Hatem</investigator_full_name>
      <investigator_title>Primary investigator</investigator_title>
    </responsible_party>
    <keyword>pharmaceutical care</keyword>
    <keyword>preference</keyword>
    <keyword>digital care</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05999279
  org study id: 12/23/D
  nct id: NCT05999279
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Digital pharmaceutical care, also known as e-pharmaceutical care or telepharmacy, refers to
        using digital technologies to provide remote pharmaceutical care services. It involves the
        application of digital tools and platforms to deliver medication-related services, patient
        counseling, medication management, and other pharmaceutical care activities. It allows
        patients to access pharmaceutical services conveniently from their homes or any location with
        an internet connection. This is particularly beneficial for individuals with limited
        mobility, those living in rural or underserved areas, or patients with difficulty visiting a
        physical pharmacy. However, it is essential to note that while digital pharmaceutical care
        provides many benefits, it may only suit some patients or situations. Some individuals may
        still prefer face-to-face interactions or may require hands-on assistance, especially for
        complex medication management. Healthcare providers should assess the appropriateness of
        digital solutions on a case-by-case basis and ensure patient privacy and data security when
        implementing digital pharmaceutical care services.
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: Patient preference
  time frame: through study completion, an average of 2 months
  description: A self-reported questionnaire was developed and piloted on the first 30 patients visiting the pharmacies. Minor modifications were performed taking into consideration two expert reviews. It is available in Arabic (native language) and English based on participants' preferences. It includes 3 parts: the first part comprises the baseline characteristics of the patients and their medical history/habits; the second part reports patients' preferences, benefits and disadvantages of each of the outcomes (in-person versus digital health); and the third part assess e-literacy among them using the e-HEALS 8-item scale previously validated on the Arab population.
  arm group label: Patient
  description: Convenient sampling of patients who took at least one medication in the past month
  intervention type: Behavioral
  intervention name: Survey
  description: Developed questionnaire to assess the literacy of patients + another survey to assess their preferences regarding traditional versus digital pharmaceutical care
  arm group label: Patient
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Georges Hatem, PhD
  phone: +351914091047
  email: georges.r.hatem@gmail.com
  last name: Sanaa Awada, PhD
  phone: +9615463375
  email: sanaa3a@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Lebanon
  responsible party type: Principal Investigator
  investigator affiliation: Lebanese University
  investigator full name: Georges Hatem
  investigator title: Primary investigator
  sharing ipd: No