Interventions numériques dirigées par des pharmaciens pour améliorer l'adhésion au traitement de la tuberculose (CARE-TB)
Adhésion numérique complète et engagement à distance pour optimiser l'adhésion au traitement aux patients atteints de tuberculose (étude de soins-TB) à Selangor, Malaisie: une étude de science de la mise en œuvre d'efficacité
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Selangor
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Sungai Buloh, Selangor, Malaisie, 47000
- Sungai Buloh Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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)
Autres noms:
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Medication adherence (Binary outcome)
Délai: 8 weeks following enrollment
|
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment. |
8 weeks following enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence rate (Continuous outcome)
Délai: 8 weeks following enrolment
|
Proportion of doses observed over 8 weeks (Dose observed divided by total observable doses prescribed) |
8 weeks following enrolment
|
|
Proportion of TB treatment completion, death, loss to follow up, and hospitalization
Délai: 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
|
|
TB cure rate
Délai: 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
Délai: From enrolment till 6 months of treatment
|
Number of adverse events or adverse drug reactions reported during TB treatment |
From enrolment till 6 months of treatment
|
|
EQ-5D-5L Health-related Quality of Life (HRQoL)
Délai: 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. |
At baseline, 2 months and 6 months of treatment
|
|
SF-12 Health-related Quality of Life (HRQoL)
Délai: 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. |
At baseline and 2 months of treatment
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Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure)
Délai: 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 |
At 2 months and 6 months of treatment
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Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure)
Délai: 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. |
After 6 months of implementation phase
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Adoption rate
Délai: 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) |
Through study completion, an average of 1 year
|
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Patient fidelity to intervention
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Reena Rajasuriar, University of Malaya
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infection latente
- Infections
- Infections bactériennes à Gram positif
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections à Actinomycétales
- Infections à mycobactéries
- Tuberculose
- Tuberculose latente
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Services de santé
- Conseils de soins de santé
- Services de santé communautaire
- Facteurs socioéconomiques
- Caractéristiques de la population
- Disciplines et activités comportementales
- Conseil directif
- Services de santé mentale
- Standard de soins
- Statut éducatif
- Entretien motivationnel
- Conseil
Autres numéros d'identification d'étude
- NMRR ID 23-03504-DLE (IIR)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data that underlie the results reported following deidentification.
Délai de partage IPD
Beginning 3 months following publication and no end date.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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