Actively Recruiting
Comprehensive Digital Adherence and Remote Engagement to Optimise Treatment Adherence for Tuberculosis Patients (CARE-TB Study) in Selangor, Malaysia: An Effectiveness-Implementation Science Study
Led by University of Malaya · Updated on 2025-07-16
160
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a digital approach to support tuberculosis (TB) treatment adherence in Malaysia, focusing on patients with confirmed pulmonary TB. The study compares a new pharmacist-led digital package called CARE-TB against the standard directly observed therapy (DOT), which involves watching patients take their medication daily. This research aims to address challenges in treatment adherence that contribute to treatment failure, relapse, and drug resistance. It uses an implementation science framework to assess multiple outcomes including patient and provider experiences and cost-effectiveness. Participants are randomly assigned to either the standard care group, where therapy is observed in person by healthcare workers or caretakers, or to the CARE-TB group. The CARE-TB package includes asynchronous video-observed therapy, digital medication reminders, telecounselling, and educational e-learning, all designed to enhance flexibility and support. The study runs over an intensive treatment phase of 8 weeks with ongoing monitoring, and continues follow-up until treatment completion or termination, approximately 6 months. During the study, participants will be monitored for medication adherence, treatment completion, hospitalization, and TB cure rates. Quality of life will be assessed at baseline, 2 months, and 6 months using standardized tools. Researchers will also evaluate how well patients and healthcare providers follow the intervention, and gather information on the acceptability and feasibility of the digital approach. Safety and adverse events will be tracked throughout the treatment period, with the total study duration extending up to one year for implementation outcomes and adoption rate assessments.
CONDITIONS
Brief Title
Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Microbiologically confirmed pulmonary tuberculosis (smear- or culture-positive)
- 18 years old or older
- Able to give consent and physically able to participate
- Own a video-recording device with internet connectivity
- Within the first 3 weeks of intensive phase TB treatment
You will not qualify if you...
- Complicated tuberculosis including meningitis, bone/joint, or disseminated TB requiring 9 to 12 months of treatment
- Confirmed or suspected drug-resistant tuberculosis
- Cognitive, motor, or visual disability hindering video device use without caretaker assistance
- Receiving injectable anti-TB drugs
- Incarceration or other involuntary detention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 6 months or until treatment completion/termination
Participants receive either the CARE-TB digital adherence package or standard directly observed therapy to support tuberculosis treatment adherence.
Regular visits as per treatment and monitoring schedule
Duration - Up to 6 months following enrollment
Participants are monitored for treatment completion, health outcomes, and quality of life after the treatment phase.
Visits at baseline, 2 months, and 6 months for quality of life assessments and implementation outcomes
Trial Site Locations
Total: 1 location
1
Sungai Buloh Hospital
Sungai Buloh, Selangor, Malaysia, 47000
Actively Recruiting
Research Team
H
Hui Moon Koh
R
Reena Rajasuriar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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