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/NCT05994144</url>
    </required_header>
    <id_info>
      <org_study_id>AISH7</org_study_id>
      <nct_id>NCT05994144</nct_id>
    </id_info>
    <brief_title>&quot;Conducting A Study On Video Observed Therapy In The Management Of Tuberculosis&quot;</brief_title>
    <acronym>VOT</acronym>
    <official_title>&quot;Effectiveness of Video Observed Therapy in the Management of Tuberculosis&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Malaya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Malaya</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 aim of this study is to measure the effectiveness usage of VOT in the treatment of TB in&#xD;
        terms of treatment adherence. The study will be a randomized controlled trial and will&#xD;
        involve 240 TB patients. The study is aimed to commence by December 2023. The study period&#xD;
        will be for 4 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is an urgent need to produce an integrated e-health system in tackling the issue of&#xD;
        remote monitoring for patient adherence. For example, in TB infection which requires close&#xD;
        monitoring for better treatment outcomes. The usage of digital health products replacing the&#xD;
        traditional DOTS will be a cost-effective method and will also bode convenient for patients&#xD;
        and staff.&#xD;
  &#xD;
        Video Observed Therapy (VOT) usage as the alternative digital health method replacing&#xD;
        traditional DOTS will be more effective in tackling adherence issues. This method has already&#xD;
        been tried in many countries like the United States of America (USA), the United Kingdom&#xD;
        (UK), Italy, and Moldova, and has proven to be more effective than traditional DOTS.&#xD;
  &#xD;
        For instance, a study by Story et al. reveals that a total of 70% of patients on VOT&#xD;
        successfully completed ≥80% of a 2-month observation compared with only 31% of those on&#xD;
        traditional DOTS (95% CI 3.10 to 9.68). A proposed intervention of adapting VOT in TB&#xD;
        treatment is a practical move, as it can improve treatment compliance and also has the added&#xD;
        benefit of being cost-effective.&#xD;
  &#xD;
        1.4 Research Question What is the effectiveness of Video Observed Therapy (VOT) in the&#xD;
        management of tuberculosis (TB) compared to the traditional Directly Observed Treatment Short&#xD;
        Course Strategy (DOTS)?&#xD;
  &#xD;
        1.5 Study Objectives&#xD;
  &#xD;
        1.5.1 General Objective The general objective of this study is to compare the effectiveness&#xD;
        of VOT with traditional DOTS in the management of TB.&#xD;
  &#xD;
        1.5.2 Specific Objectives I. To develop VOT intervention in the management of TB. II. To&#xD;
        compare the effectiveness of VOT as compared to traditional DOTS. III. To measure patient&#xD;
        satisfaction using VOT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>For all participants who are randomised into VOT arm or traditional DOTS arm. Control group : Patients allocated into the traditional DOTS arm will follow the usual protocol as all other patients assigned to DOTS under Ministry of Health Malaysia Intervention group : Patient will be observed on their daily TB medication consumption via teleconference by using WhatsApp video call.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment adherence in percentage from both arms</measure>
      <time_frame>60 days</time_frame>
      <description>Number of days medicine consumed/over 60 days intensive period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Seroconversion rate</measure>
      <time_frame>60 days</time_frame>
      <description>Number of successful sero-conversion patients from sputum smear positive to sputum smear negative by the end of the intensive phase.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side effects incidents report</measure>
      <time_frame>60 days</time_frame>
      <description>Number of reported side effects detected from both arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients suffering with side effects</measure>
      <time_frame>60 days</time_frame>
      <description>Number of patients having side effects detected from both arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Degree of patient's satisfaction</measure>
      <time_frame>Questionnaire using Likert scale. &quot;Score 1:least satisfied,Score 5: most satisfied&quot;</time_frame>
      <description>The degree of satisfaction of the participants from both arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time save</measure>
      <time_frame>120 days</time_frame>
      <description>Overall time spent by patients from both arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost saving</measure>
      <time_frame>60 days</time_frame>
      <description>Overall money spent by patients from both arms.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Tuberculosis</condition>
    <arm_group>
      <arm_group_label>CONTROL</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group, traditional DOTS is the group who will be attending daily to their respective PR-1/PR-2 throughout intensive phase.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>INTERVENTION ARM (VOT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intervention group, video observed therapy (VOT) is the group who will be teleconferencing daily with their respective PR-1/PR-2 TB team via WhatsApp throughout the intensive phase.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>VIDEO OBSERVED THERAPY</intervention_name>
      <description>Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.</description>
      <arm_group_label>INTERVENTION ARM (VOT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          i. All PTB smear-positive patients. ii. Patients aged 18 years and above. iii. Possess a&#xD;
          digital phone or other equivalent gadget equipped with a WhatsApp application.&#xD;
  &#xD;
          iv. Able to accurately identify each TB medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          i. Recurrent PTB infection. ii. Patients who are extremely ill, have no proper social&#xD;
          support, no caretakers, and are hospitalized.&#xD;
  &#xD;
          iii. Patients in prison during the time of diagnosis or treatment.&#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>KARTIK KALIYANA SUNDARAM, MPH</last_name>
      <phone>0060124975343</phone>
      <email>kartik25@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Sultanah Nur Zahira</name>
        <address>
          <city>Kuala Terengganu</city>
          <state>Terengganu</state>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tuberculosis</keyword>
    <keyword>Digital health</keyword>
    <keyword>video observed therapy</keyword>
    <keyword>treatment adherence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tuberculosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS</ipd_description>
    </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/NCT05994144
  org study id: AISH7
  nct id: NCT05994144
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to measure the effectiveness usage of VOT in the treatment of TB in
        terms of treatment adherence. The study will be a randomized controlled trial and will
        involve 240 TB patients. The study is aimed to commence by December 2023. The study period
        will be for 4 months.
  There is an urgent need to produce an integrated e-health system in tackling the issue of
        remote monitoring for patient adherence. For example, in TB infection which requires close
        monitoring for better treatment outcomes. The usage of digital health products replacing the
        traditional DOTS will be a cost-effective method and will also bode convenient for patients
        and staff.
  
        Video Observed Therapy (VOT) usage as the alternative digital health method replacing
        traditional DOTS will be more effective in tackling adherence issues. This method has already
        been tried in many countries like the United States of America (USA), the United Kingdom
        (UK), Italy, and Moldova, and has proven to be more effective than traditional DOTS.
  
        For instance, a study by Story et al. reveals that a total of 70% of patients on VOT
        successfully completed ≥80% of a 2-month observation compared with only 31% of those on
        traditional DOTS (95% CI 3.10 to 9.68). A proposed intervention of adapting VOT in TB
        treatment is a practical move, as it can improve treatment compliance and also has the added
        benefit of being cost-effective.
  
        1.4 Research Question What is the effectiveness of Video Observed Therapy (VOT) in the
        management of tuberculosis (TB) compared to the traditional Directly Observed Treatment Short
        Course Strategy (DOTS)?
  
        1.5 Study Objectives
  
        1.5.1 General Objective The general objective of this study is to compare the effectiveness
        of VOT with traditional DOTS in the management of TB.
  
        1.5.2 Specific Objectives I. To develop VOT intervention in the management of TB. II. To
        compare the effectiveness of VOT as compared to traditional DOTS. III. To measure patient
        satisfaction using VOT.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: For all participants who are randomised into VOT arm or traditional DOTS arm. Control group : Patients allocated into the traditional DOTS arm will follow the usual protocol as all other patients assigned to DOTS under Ministry of Health Malaysia Intervention group : Patient will be observed on their daily TB medication consumption via teleconference by using WhatsApp video call.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Treatment adherence in percentage from both arms
  time frame: 60 days
  description: Number of days medicine consumed/over 60 days intensive period
  measure: Seroconversion rate
  time frame: 60 days
  description: Number of successful sero-conversion patients from sputum smear positive to sputum smear negative by the end of the intensive phase.
  measure: Side effects incidents report
  time frame: 60 days
  description: Number of reported side effects detected from both arms.
  measure: Patients suffering with side effects
  time frame: 60 days
  description: Number of patients having side effects detected from both arms.
  measure: Degree of patient's satisfaction
  time frame: Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied"
  description: The degree of satisfaction of the participants from both arms.
  measure: Time save
  time frame: 120 days
  description: Overall time spent by patients from both arms.
  measure: Cost saving
  time frame: 60 days
  description: Overall money spent by patients from both arms.
  arm group label: CONTROL
  arm group type: No Intervention
  description: The control group, traditional DOTS is the group who will be attending daily to their respective PR-1/PR-2 throughout intensive phase.
  arm group label: INTERVENTION ARM (VOT)
  arm group type: Active Comparator
  description: The intervention group, video observed therapy (VOT) is the group who will be teleconferencing daily with their respective PR-1/PR-2 TB team via WhatsApp throughout the intensive phase.
  intervention type: Other
  intervention name: VIDEO OBSERVED THERAPY
  description: Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.
  arm group label: INTERVENTION ARM (VOT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: KARTIK KALIYANA SUNDARAM, MPH
  phone: 0060124975343
  email: kartik25@hotmail.com
  facility: 
  country: Malaysia
  responsible party type: Sponsor
  mesh term: Tuberculosis
  sharing ipd: No
  ipd description: IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS