VOT: "Conducting A Study On Video Observed Therapy In The Management Of Tuberculosis"
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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
Arms and Interventions
| 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. |
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| 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
Primary Outcome Measures
- Treatment adherence in percentage from both arms [60 days]
Number of days medicine consumed/over 60 days intensive period
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Able to accurately identify each TB medication.
Exclusion Criteria:
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Recurrent PTB infection. ii. Patients who are extremely ill, have no proper social support, no caretakers, and are hospitalized.
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Patients in prison during the time of diagnosis or treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Sultanah Nur Zahira | Kuala Terengganu | Terengganu | Malaysia |
Sponsors and Collaborators
- University of Malaya
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AISH7