"Conducting A Study On Video Observed Therapy In The Mana... | NCT05994144

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

NCT05994144

Sponsor

University of Malaya

Status

Unknown status

Last Update Posted

Aug 16, 2023Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Tuberculosis

Interventions

VIDEO OBSERVED THERAPY

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Mar 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Jul 19, 2023

First Submission Date that Met QC Criteria

Aug 15, 2023

First Posted Date

Aug 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2023

Last Update Posted Date

Aug 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CONTROL	No Intervention	The control group, traditional DOTS is the group who will be attending daily to their respective PR-1/PR-2 throughout intensive phase.
INTERVENTION ARM (VOT)	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VIDEO OBSERVED THERAPY	Other	Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.	INTERVENTION ARM (VOT)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
KARTIK KALIYANA SUNDARAM, MPH	Contact	0060124975343		kartik25@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sultanah Nur Zahira		Kuala Terengganu	Terengganu		Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD WILL NOT BE SHARED FOR UNSPECIFIED REASONS

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D000074822	Treatment Adherence and Compliance

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

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.