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"Conducting A Study On Video Observed Therapy In The Management Of Tuberculosis" (VOT)

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ClinicalTrials.gov Identifier: NCT05994144
Recruitment Status : Not yet recruiting
First Posted : August 16, 2023
Last Update Posted : August 16, 2023
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: VIDEO OBSERVED THERAPY Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: "Effectiveness of Video Observed Therapy in the Management of Tuberculosis"
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
No Intervention: CONTROL
The control group, traditional DOTS is the group who will be attending daily to their respective PR-1/PR-2 throughout intensive phase.
Active Comparator: INTERVENTION ARM (VOT)
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.
 Other: VIDEO OBSERVED THERAPY
Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment adherence in percentage from both arms [ Time Frame: 60 days ]
    Number of days medicine consumed/over 60 days intensive period


Secondary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 60 days ]
    Number of successful sero-conversion patients from sputum smear positive to sputum smear negative by the end of the intensive phase.

  2. Side effects incidents report [ Time Frame: 60 days ]
    Number of reported side effects detected from both arms.

  3. Patients suffering with side effects [ Time Frame: 60 days ]
    Number of patients having side effects detected from both arms.

  4. Degree of patient's satisfaction [ Time Frame: Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied" ]
    The degree of satisfaction of the participants from both arms.

  5. Time save [ Time Frame: 120 days ]
    Overall time spent by patients from both arms.

  6. Cost saving [ Time Frame: 60 days ]
    Overall money spent by patients from both arms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i. All PTB smear-positive patients. ii. Patients aged 18 years and above. iii. Possess a digital phone or other equivalent gadget equipped with a WhatsApp application.

iv. Able to accurately identify each TB medication.

Exclusion Criteria:

i. Recurrent PTB infection. ii. Patients who are extremely ill, have no proper social support, no caretakers, and are hospitalized.

iii. Patients in prison during the time of diagnosis or treatment.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994144


Contacts
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Contact: KARTIK KALIYANA SUNDARAM, MPH 0060124975343 kartik25@hotmail.com

Locations
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Malaysia
Hospital Sultanah Nur Zahira
Kuala Terengganu, Terengganu, Malaysia
Sponsors and Collaborators
University of Malaya
More Information
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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT05994144    
Other Study ID Numbers: AISH7
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: August 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Malaya:
Tuberculosis
Digital health
video observed therapy
treatment adherence
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections