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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Other: VIDEO OBSERVED THERAPY

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: KARTIK KALIYANA SUNDARAM, MPH; Phone Number: 0060124975343; Email: kartik25@hotmail.com

Study Locations

• Malaysia
  • Terengganu
    • Kuala Terengganu, Terengganu, Malaysia
      • Hospital Sultanah Nur Zahira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment adherence in percentage from both arms	Number of days medicine consumed/over 60 days intensive period	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Side effects incidents report	Number of reported side effects detected from both arms.	60 days
Patients suffering with side effects	Number of patients having side effects detected from both arms.	60 days
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"
Time save	Overall time spent by patients from both arms.	120 days
Cost saving	Overall money spent by patients from both arms.	60 days

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Tuberculosis; treatment adherence; Digital health; video observed therapy
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: AISH7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No