Farmasøyt-ledede digitale intervensjoner for å forbedre tuberkulosebehandling etterfølgende overholdelse av tuberkulose (CARE-TB)
Omfattende digital etterlevelse og fjernengasjement for å optimalisere behandling av behandling for tuberkulosepasienter (Care-TB-studie) i Selangor, Malaysia: en effektivitetsimplementeringsvitenskapsstudie
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Selangor
-
Sungai Buloh, Selangor, Malaysia, 47000
- Sungai Buloh Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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)
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Medication adherence (Binary outcome)
Tidsramme: 8 weeks following enrollment
|
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment. |
8 weeks following enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence rate (Continuous outcome)
Tidsramme: 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
Tidsramme: 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
Tidsramme: At 6 months of treatment
|
Proportion of microbiological TB clearance (e.g. AFB smear/ MTB PCR/ MTB culture) |
At 6 months of treatment
|
|
Adverse event reporting
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
|
Implementation Outcomes: Acceptability, Feasibility, Appropriateness (Quantitative measure)
Tidsramme: 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
|
|
Perceived acceptability, feasibility, and fit of the intervention (Qualitative measure)
Tidsramme: 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
|
|
Adoption rate
Tidsramme: 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
|
|
Patient fidelity to intervention
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Reena Rajasuriar, University of Malaya
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Latent infeksjon
- Infeksjoner
- Gram-positive bakterielle infeksjoner
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Actinomycetales infeksjoner
- Mycobacterium infeksjoner
- Tuberkulose
- Latent tuberkulose
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Community Health Services
- Sosioøkonomiske faktorer
- Befolkningskarakteristikker
- Atferdsdisipliner og aktiviteter
- Direktivrådgivning
- Psykiske helsetjenester
- Standard for omsorg
- Utdanningsstatus
- Motiverende intervjuing
- Rådgivning
Andre studie-ID-numre
- NMRR ID 23-03504-DLE (IIR)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data that underlie the results reported following deidentification.
IPD-delingstidsramme
Beginning 3 months following publication and no end date.
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
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