結核治療の遵守を改善するための薬剤師主導のデジタル介入 (CARE-TB)
マレーシアのセランゴールでの結核患者の治療遵守（CARE-TB研究）の治療遵守を最適化するための包括的なデジタル順守とリモートエンゲージメント：有効性と実装科学研究
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Selangor
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Sungai Buloh、Selangor、マレーシア、47000
- Sungai Buloh Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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)
他の名前：
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実験的：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Medication adherence (Binary outcome)
時間枠：8 weeks following enrollment
|
Completed ≥ 80% scheduled observations during the 8 weeks following enrolment. |
8 weeks following enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence rate (Continuous outcome)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Reena Rajasuriar、University of Malaya
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NMRR ID 23-03504-DLE (IIR)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data that underlie the results reported following deidentification.
IPD 共有時間枠
Beginning 3 months following publication and no end date.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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