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

NCT05994144 | Unknown DMC

• 1 other identifier: AISH7
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Digital health; video observed therapy; treatment adherence

Outcome Measures

Primary Outcomes (1)

• Treatment adherence in percentage from both arms

  Number of days medicine consumed/over 60 days intensive period

  60 days

Secondary Outcomes (6)

• Seroconversion rate

  60 days

• Side effects incidents report

  60 days

• Patients suffering with side effects

  60 days

• Degree of patient's satisfaction

  Questionnaire using Likert scale. "Score 1:least satisfied,Score 5: most satisfied"

• Time save

  120 days

Study Arms (2)

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

VIDEO OBSERVED THERAPY OTHER

Video-observed therapy is the usage of teleconferencing to observe anti-TB medication ingestion.

INTERVENTION ARM (VOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Hospital Sultanah Nur Zahira

Kuala Terengganu, Terengganu, Malaysia

Location

MeSH Terms

Conditions

Tuberculosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Health Behavior; Behavior

Central Study Contacts

KARTIK KALIYANA SUNDARAM, MPH

CONTACT

0060124975343; kartik25@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 16, 2023
• Study Start: December 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)