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

Tuberculosis Clinical Trial

— VOT  

Official title:

"Effectiveness of Video Observed Therapy in the Management of Tuberculosis"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994144
• Other study ID #: AISH7
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University of Malaya
• Contact: KARTIK KALIYANA SUNDARAM, MPH
• Phone: 0060124975343
• Email: kartik25[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• VIDEO OBSERVED THERAPY
Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.

Locations

Country	Name	City	State
Malaysia	Hospital Sultanah Nur Zahira	Kuala Terengganu	Terengganu

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment adherence in percentage from both arms	Number of days medicine consumed/over 60 days intensive period	60 days
Secondary	Seroconversion rate	Number of successful sero-conversion patients from sputum smear positive to sputum smear negative by the end of the intensive phase.	60 days
Secondary	Side effects incidents report	Number of reported side effects detected from both arms.	60 days
Secondary	Patients suffering with side effects	Number of patients having side effects detected from both arms.	60 days
Secondary	Degree of patient's satisfaction	The degree of satisfaction of the participants from both arms.	Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied"
Secondary	Time save	Overall time spent by patients from both arms.	120 days
Secondary	Cost saving	Overall money spent by patients from both arms.	60 days