<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/NCT04412239</url>
  </required_header>
  <id_info>
    <org_study_id>NO, F6-2017/NTP-ADMIN</org_study_id>
    <nct_id>NCT04412239</nct_id>
  </id_info>
  <brief_title>To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic</brief_title>
  <acronym>Coronavirus19</acronym>
  <official_title>To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Science Center of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pakistan Institute of Medical Sciences Islamabad Pakistan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>District Headquarter Hospital Bannu Pakistan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Health Science Center of Xi'an Jiaotong 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>
      The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB&#xD;
      treatment. For the follow-up of selected patients, telephone consultations may be efficient&#xD;
      and cost-effective. The aim of the study is to assess the efficiency and the satisfaction&#xD;
      with telephone consultation for the pharmacist and the TB patient. The study was conducted in&#xD;
      tertiary care hospital TB control centres patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tuberculosis (TB) is the world's biggest killer among infectious diseases, claiming more than&#xD;
      4000 lives each day. The unprecedented coronavirus pandemic seriously impacts people with&#xD;
      pre-existing health conditions. People who have TB are usually more vulnerable to other&#xD;
      infections, including the novel coronavirus, due to pre-existing lung damage. They are at a&#xD;
      higher risk of developing complications from COVID-19. Certain populations are at greater&#xD;
      risk of TB, because of where they live, where they work or because of other socio-economic&#xD;
      factors which result in them experiencing barriers to accessing health services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Anticipated">December 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficiency of the telephone consultation,</measure>
    <time_frame>2 Months</time_frame>
    <description>To improve patient centered care/patient prescription refill</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>2 Month</time_frame>
    <description>Patient satisfaction Patient satisfaction resulting from pharmacist-led pharmaceutical care will be assessed Patient satisfaction feedback (PSF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence Rate</measure>
    <time_frame>2 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>TB - Tuberculosis</condition>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>Telephone Consultation in TB Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient-centred advice on Telephone Consultation in TB Patients:</intervention_name>
    <description>The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.</description>
    <arm_group_label>Telephone Consultation in TB Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        New, smear-positive drug-susceptible TB who have been on treatment for less than two weeks&#xD;
        Access to a mobile phone (self-reported)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who do not have regular access to a mobile phone Patients who have previously&#xD;
        received TB treatment Patients who have another member in their household who is already a&#xD;
        part of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Farman Ul Khan, Master</last_name>
    <phone>003319443131</phone>
    <email>farmankhan@bs.qau.edu.pk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yu Fang, Phd</last_name>
    <email>yufang@xjtu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dhq Bannu Kpk</name>
      <address>
        <city>Bannu</city>
        <state>KPK</state>
        <zip>2800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Farman Ull ah Khan</last_name>
      <phone>+92331-3319443131</phone>
      <email>farmankhan@bs.qau.pk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>District Bannu TB Control Center</name>
      <address>
        <city>Bannu</city>
        <state>KPK</state>
        <zip>2800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asif Ul Khan, Master</last_name>
      <phone>0092334087008</phone>
      <email>asifkhanustb@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Farman Ul Khan, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yu Fang, Phd</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Health Science Center of Xi'an Jiaotong University</investigator_affiliation>
    <investigator_full_name>Farman Ullah Khan</investigator_full_name>
    <investigator_title>Department of Pharmacy Administration and Clinical Pharmacy School of Pharmacy, Health Science Centre Xi'an Jiao tong University.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04412239
org study id: NO, F6-2017/NTP-ADMIN
nct id: NCT04412239
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB
      treatment. For the follow-up of selected patients, telephone consultations may be efficient
      and cost-effective. The aim of the study is to assess the efficiency and the satisfaction
      with telephone consultation for the pharmacist and the TB patient. The study was conducted in
      tertiary care hospital TB control centres patients.
Tuberculosis (TB) is the world's biggest killer among infectious diseases, claiming more than
      4000 lives each day. The unprecedented coronavirus pandemic seriously impacts people with
      pre-existing health conditions. People who have TB are usually more vulnerable to other
      infections, including the novel coronavirus, due to pre-existing lung damage. They are at a
      higher risk of developing complications from COVID-19. Certain populations are at greater
      risk of TB, because of where they live, where they work or because of other socio-economic
      factors which result in them experiencing barriers to accessing health services.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Efficiency of the telephone consultation,
time frame: 2 Months
description: To improve patient centered care/patient prescription refill
measure: Patient satisfaction
time frame: 2 Month
description: Patient satisfaction Patient satisfaction resulting from pharmacist-led pharmaceutical care will be assessed Patient satisfaction feedback (PSF)
measure: Adherence Rate
time frame: 2 Months
arm group label: Telephone Consultation in TB Patients
arm group type: Experimental
description: The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective.
intervention type: Behavioral
intervention name: Patient-centred advice on Telephone Consultation in TB Patients:
description: The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.
arm group label: Telephone Consultation in TB Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farman Ul Khan, Master
phone: 003319443131
email: farmankhan@bs.qau.edu.pk
last name: Yu Fang, Phd
email: yufang@xjtu.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Health Science Center of Xi'an Jiaotong University
investigator full name: Farman Ullah Khan
investigator title: Department of Pharmacy Administration and Clinical Pharmacy School of Pharmacy, Health Science Centre Xi'an Jiao tong University.
mesh term: Tuberculosis
mesh term: COVID-19