Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease (IMPLEMENT-CKD)
Chronic kidney disease (CKD) affects millions, especially in low- and middle-income countries, where many die early due to lack of treatment. One group of medicines, called SGLT2 inhibitors (SGLT2i), have been shown to slow down kidney damage and reduce the risk of heart-related deaths. The IMPLEMENT-CKD project will work with communities in Thailand, Fiji and Samoa to make it easier for people with CKD or type 2 diabetes to get these life-saving medicines as part of their regular care.
調査の概要
詳細な説明
Chronic kidney disease (CKD) affects over 850 million people globally, with 80% living in low- and middle-income countries (LMICs) where access to effective treatment is limited. Sodium-glucose co-transporter 2 inhibitors (SGLT2i), now listed on the WHO Essential Medicines List, have demonstrated significant benefits in slowing CKD progression and reducing cardiovascular mortality. The IMPLEMENT-CKD project is a co-designed, multi-phased, multi-country health systems strengthening initiative aimed at improving equitable access to and sustained use of SGLT2i in Thailand, and the Pacific Islands. The intervention is contextually tailored, prioritising stakeholder engagement, cultural adaptation, and scalable care models. A mixed-method, adaptive implementation study will be conducted in phases. The pre-implementation phase uses community-based participatory action research and knowledge co-creation to develop culturally relevant strategies. During implementation, clinical staff are trained to initiate SGLT2i therapy in eligible adults with CKD (eGFR >20 mL/min/1.73m²) or type 2 diabetes. Real-world delivery is supported by monthly prescribing audits and mobile surveys. Strategies are refined biannually using Plan-Do-Study-Act (PDSA) cycles. The scale-up phase engages stakeholders to advocate for national inclusion of SGLT2i through policy briefs and collaboration with professional bodies. The primary implementation outcome is 50% reach-defined as the proportion of eligible patients initiated on SGLT2i. Additional outcomes include adoption, fidelity, acceptability, and normalisation of practice. Health systems outcomes include changes in protocols, workforce capacity, medicine availability, and policy engagement. Clinical outcomes such as kidney failure and cardiovascular death will be monitored using routine data. The project aims to enhance CKD management, reduce disparities, and inform scalable, evidence-based policy for chronic disease care in LMICs.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Rathika Krishnasamy
- 電話番号：+61 401 696 408
- メール：implement-ckd@uq.edu.au
研究連絡先のバックアップ
- 名前：Laura Hickey
- メール：implement-ckd@uq.edu.au
研究場所
-
-
-
Apia、サモア
- Department of Health, Samoa
-
コンタクト：
- Ben Matalavea
- メール：lbmatalavea@nkfs.ws
-
コンタクト：
- Malama Tafuna'i
-
-
-
-
-
Bangkok、タイ
- Chulalongkorn University
-
コンタクト：
- Talerngsak Kanjanabuch
-
-
-
-
-
Suva、フィジー
- Ministry of Health, Fiji
-
コンタクト：
- Anis Ta'eed
- メール：implement-ckd@uq.edu.au
-
コンタクト：
- Yogeshni Chandra
-
-
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
サンプリング方法
調査対象母集団
Participants will be recruited from Thailand, Fiji and Samoa.
説明
Inclusion Criteria:
People ≥ 18 years of age with one or more of the following:
- chronic kidney disease (CKD) with eGFR > 20 mL/min/1.73m²;
- type 2 diabetes mellitus (T2DM).
Exclusion Criteria:
- Nil
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
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
A Reach of 50% of eligible patients initiated on SGLT2i therapy
時間枠：24 months
|
Proportion of eligible patients initiated on SGLT2i therapy, calculated as number of patients who were prescribed SGLT2i therapy during the intervention period/ number of patients meeting predefined eligibility criteria. |
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to SGLT2i therapy
時間枠：24 months
|
Patient reported uptake |
24 months
|
|
Effectiveness
時間枠：24 months
|
Rates of CKD detection |
24 months
|
|
Adoption
時間枠：24 months
|
% of participating centres that initiate implementation strategies. |
24 months
|
|
Implementation
時間枠：24 months
|
Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
|
|
Maintenance
時間枠：24 months
|
Score for the extent of normalisation of practice (Normalisation Measure Development tool) |
24 months
|
|
% initiation of other CKD management
時間枠：24 months
|
24 months
|
|
|
Effectiveness
時間枠：24 months
|
Rates of Kidney Failure |
24 months
|
|
Effectiveness
時間枠：24 months
|
Rates of CV Death |
24 months
|
|
Effectiveness
時間枠：24 months
|
Rates adverse drug reactions |
24 months
|
|
Effectiveness
時間枠：24 months
|
Rates all-cause hospitalisations |
24 months
|
協力者と研究者
捜査官
- 主任研究者：Rathika Krishnasamy、The University of Queensland
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- 25.01
- APP2054344/GACDHS10 (その他の助成金/資金番号：NHMRC-GACD)
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
Data sets will be made available by the Sponsor to researchers within the IMPLEMENT-CKD study for analysis of sub-studies after the primary manuscript has been accepted for publication.
For researchers outside the IMPLEMENT-CKD study, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing and research team expertise. Appropriate data will be made available to approved proposals. This process will be in effect for a period of 2 to 5 years following publication of the main study results. After 5 years, the data will be available in the Sponsor's data warehouse but without investigator support other than deposited metadata.
IPD 共有アクセス基準
2 to 5 years following publication of the main study results.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。