Tuberculosis (TB)
Conditions
Keywords
tuberculosis, active tuberculosis, monitoring, video observed therapy, education, pharmacist, digital, implementation science, cost, motivational
Brief summary
The gold standard for tuberculosis (TB) treatment support requires directly observed therapy (DOT), which means a trained health worker observes the patient swallow each dose of medication every day for 2 months. Despite the practice of DOT in Malaysia, 1 in 20 patients are loss-to-follow-up and non-adherent to treatment. Sub-optimal adherence due to poor treatment acceptability and social desirability promotes TB treatment failure, disease relapse, on-going transmission, drug resistance, and death. Telemedicine offers a flexible and less invasive option to support TB treatment adherence. Despite 97% internet and smartphone penetration rates, the practical implementation of digital adherence strategies to support and monitor TB treatment remains untested in Malaysia. The investigators propose to design, implement, and measure the effectiveness of a comprehensive, pharmacist-led digital solution for TB treatment support called CARE-TB which combines a package of asynchronous video-observed therapy, digital reminders, telecounselling and e-learning. In this multi-method effectiveness-implementation (Type 2) study using the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, the investigators aim 1) To identify patient and provider-level facilitators and barriers to CARE-TB adoption via qualitative evaluation and to design a stakeholder-informed implementation strategy, (2) To assess effectiveness of CARE-TB strategy by evaluating (i) implementation outcomes, (ii) patient health outcomes, and (iii) service outcomes, and (3) To evaluate the cost-effectiveness of CARE-TB compared to standard of care from a societal perspective. This study will leverage digital platforms to expand the reach of TB adherence support, enhance adherence to TB treatment and improve treatment completion rates, while utilising existing personnel and resources in among the busiest TB treatment centres in the country.
Interventions
BEHAVIORALCARE-TB digital adherence package
CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
BEHAVIORALStandard Care
Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Microbiologically confirmed pulmonary TB (smear- or culture-positive PTB) 2. 18 years old or older 3. Able to give consent and physically able to participate in the study 4. Own a video-recording device with internet connectivity 5. Within the first 3 weeks of intensive phase TB treatment
Exclusion criteria
1. Complicated TB disease including TB meningitis, TB bone/joint, and disseminated TB with planned treatment duration of 9 to 12 months. 2. Confirmed or suspected drug-resistant (DR)-TB 3. Documented cognitive, motor, or visual disability that will hinder video device use and lack assistance of a caretaker 4. Receiving injectable anti-TB drugs 5. Incarceration or other involuntary detention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence (Binary outcome) | 8 weeks following enrollment | Completed ≥ 80% scheduled observations during the 8 weeks following enrolment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rate (Continuous outcome) | 8 weeks following enrolment | Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed) |
| Proportion of TB treatment completion, death, loss to follow up, and hospitalization | From enrolment till 6 months or treatment completion/ termination | Proportion of patients completing TB treatment, died, are lost to follow-up or hospitalized during TB treatment |
| TB cure rate | At 6 months of treatment | Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture) |
| Adverse event reporting | From enrolment till 6 months of treatment | Number of adverse events or adverse drug reactions reported during TB treatment |
| EQ-5D-5L Health-related Quality of Life (HRQoL) | At baseline, 2 months and 6 months of treatment | HRQoL will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Unit of Measure: EQ-5D index score (range: -0.281 to 1.000 based on country-specific value set) Interpretation: Higher scores indicate better health-related quality of life. |
| SF-12 Health-related Quality of Life (HRQoL) | At baseline and 2 months of treatment | The 12-Item Short Form Survey (SF-12) will be used to assess participants' health-related quality of life. Two summary scores will be generated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scoring scale is from 0 to 100, the higher the score the better the health related quality of life. |
| Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure) | At 2 months and 6 months of treatment | Implementation outcomes will be assessed using the combined Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM) questionnaire. Unit of Measure: Total and individual mean scores on 5-point Likert scale (1 = completely disagree, 5 = completely agree) Scoring: Each subscale consists of 4 items; subscale scores range from 4 to 20 Interpretation: Higher scores indicate greater perceived acceptability, feasibility, or appropriateness of the intervention |
| Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure) | After 6 months of implementation phase | Semi-structured qualitative interviews and focus group discussions will explore participants' perceptions of the intervention's acceptability, feasibility, and fit. Unit of Measure: Thematic findings from qualitative analysis Interpretation: Interview data will be thematically coded and analyzed to identify key barriers, facilitators, and contextual factors. |
| Adoption rate | Through study completion, an average of 1 year | Rate of uptake (number of participants who agree to use the CARE TB strategy divided by total number offered) |
| Patient fidelity to intervention | 8 weeks following enrolment | Rate of drop-out (count of individuals who fulfill any of the following: withdraw from the study, switch arms, appointment no-show) |
| Healthcare providers (HCP) fidelity to intervention | 8 weeks following enrolment | Rate of reengagement attempt (count of reminders sent to reestablish VOT over total number of missed VOT appointments) |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORReena Rajasuriar
University of Malaya
Outcome results
None listed