Intervenciones digitales dirigidas por farmacéuticos para mejorar la adherencia al tratamiento de tuberculosis (CARE-TB)
La adherencia digital integral y la participación remota para optimizar la adherencia al tratamiento para pacientes con tuberculosis (estudio de cuidados TB) en Selangor, Malasia: un estudio de ciencia de implementación de efectividad
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Selangor
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Sungai Buloh, Selangor, Malasia, 47000
- Sungai Buloh Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Microbiologically confirmed TB
- 18 years old or older
- Able to give consent and physically able to participate in the study
- Own a video-recording device with internet connectivity
- Within the first 3 weeks of intensive phase TB treatment
Exclusion Criteria:
- Complicated TB disease including TB meningitis, TB bone/joint, and disseminated TB with planned treatment duration of 9 to 12 months.
- Confirmed or suspected drug-resistant (DR)-TB
- Documented cognitive, motor, or visual disability that will hinder video device use and lack assistance of a caretaker
- Receiving injectable anti-TB drugs
- Incarceration or other involuntary detention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard care arm
Directly observed therapy (healthcare or caretaker-based) |
Directly observed therapy at any government healthcare facility (by nurses) or at home (by caretaker)
Otros nombres:
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Experimental: CARE-TB arm
CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients. |
CARE-TB package includes pharmacist-led asynchronous video observed therapy, digital medication reminders, telecounselling and e-learning for patients.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Medication adherence (Binary outcome)
Periodo de tiempo: 8 weeks following enrollment
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Completed ≥ 80% scheduled observations during the 8 weeks following enrolment. |
8 weeks following enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adherence rate (Continuous outcome)
Periodo de tiempo: 8 weeks following enrolment
|
Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed) |
8 weeks following enrolment
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Proportion of TB treatment completion, death, loss to follow up, and hospitalization
Periodo de tiempo: 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 |
From enrolment till 6 months or treatment completion/ termination
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TB cure rate
Periodo de tiempo: At 6 months of treatment
|
Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture) |
At 6 months of treatment
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Adverse event reporting
Periodo de tiempo: From enrolment till 6 months of treatment
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Number of adverse events or adverse drug reactions reported during TB treatment |
From enrolment till 6 months of treatment
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EQ-5D-5L Health-related Quality of Life (HRQoL)
Periodo de tiempo: At baseline, 2 months and 6 months of treatment
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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. |
At baseline, 2 months and 6 months of treatment
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SF-12 Health-related Quality of Life (HRQoL)
Periodo de tiempo: At baseline and 2 months of treatment
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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. |
At baseline and 2 months of treatment
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Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure)
Periodo de tiempo: At 2 months and 6 months of treatment
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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 |
At 2 months and 6 months of treatment
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Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure)
Periodo de tiempo: After 6 months of implementation phase
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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. |
After 6 months of implementation phase
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Adoption rate
Periodo de tiempo: Through study completion, an average of 1 year
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Rate of uptake (number of participants who agree to use the CARE TB strategy divided by total number offered) |
Through study completion, an average of 1 year
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Patient fidelity to intervention
Periodo de tiempo: 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) |
8 weeks following enrolment
|
|
Healthcare providers (HCP) fidelity to intervention
Periodo de tiempo: 8 weeks following enrolment
|
Rate of reengagement attempt (count of reminders sent to reestablish VOT over total number of missed VOT appointments) |
8 weeks following enrolment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Reena Rajasuriar, University of Malaya
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infección latente
- Infecciones
- Infecciones por bacterias grampositivas
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por Actinomycetales
- Infecciones por micobacterias
- Tuberculosis
- Tuberculosis latente
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud comunitarios
- Factores socioeconómicos
- Características de la población
- Disciplinas y actividades de comportamiento
- Asesoramiento directivo
- Servicios de salud mental
- Estándar de cuidado
- Estado educativo
- Entrevistas motivacionales
- Asesoramiento
Otros números de identificación del estudio
- NMRR ID 23-03504-DLE (IIR)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data that underlie the results reported following deidentification.
Marco de tiempo para compartir IPD
Beginning 3 months following publication and no end date.
Criterios de acceso compartido de IPD
Investigators whose proposed used of data has been approved by independent review. Proposals should be submitted to kohhuimoon@moh.gov.my. To gain access, a data sharing agreement must be signed.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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