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

Not Applicable

Not yet recruiting

• Conditions: Tuberculosis
• Interventions: Other: VIDEO OBSERVED THERAPY

• Registration Number: NCT05994144
• Lead Sponsor: University of Malaya

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.

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 Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16
• Study Start: 2023-12-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION ARM (VOT)	VIDEO OBSERVED THERAPY	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.

Primary Outcome Measures

Name	Time	Method
Treatment adherence in percentage from both arms	60 days	Number of days medicine consumed/over 60 days intensive period

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate	60 days	Number of successful sero-conversion patients from sputum smear positive to sputum smear negative by the end of the intensive phase.
Side effects incidents report	60 days	Number of reported side effects detected from both arms.
Patients suffering with side effects	60 days	Number of patients having side effects detected from both arms.
Degree of patient's satisfaction	Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied"	The degree of satisfaction of the participants from both arms.
Time save	120 days	Overall time spent by patients from both arms.
Cost saving	60 days	Overall money spent by patients from both arms.

Trial Locations

Locations (1)

Hospital Sultanah Nur Zahira; 🇲🇾 Kuala Terengganu, Terengganu, Malaysia