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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Rathika Krishnasamy
- 电话号码：+61 401 696 408
- 邮箱：implement-ckd@uq.edu.au
研究联系人备份
- 姓名：Laura Hickey
- 邮箱：implement-ckd@uq.edu.au
学习地点
-
-
-
Suva、斐济
- Ministry of Health, Fiji
-
接触：
- Anis Ta'eed
- 邮箱：implement-ckd@uq.edu.au
-
接触：
- Yogeshni Chandra
-
-
-
-
-
Bangkok、泰国
- Chulalongkorn University
-
接触：
- Talerngsak Kanjanabuch
-
-
-
-
-
Apia、萨摩亚
- Department of Health, Samoa
-
接触：
- Ben Matalavea
- 邮箱：lbmatalavea@nkfs.ws
-
接触：
- Malama Tafuna'i
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Participants will be recruited from Thailand, Fiji and Samoa.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
A Reach of 50% of eligible patients initiated on SGLT2i therapy
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adherence to SGLT2i therapy
大体时间：24 months
|
Patient reported uptake |
24 months
|
|
Effectiveness
大体时间：24 months
|
Rates of CKD detection |
24 months
|
|
Adoption
大体时间：24 months
|
% of participating centres that initiate implementation strategies. |
24 months
|
|
Implementation
大体时间：24 months
|
Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
|
|
Maintenance
大体时间：24 months
|
Score for the extent of normalisation of practice (Normalisation Measure Development tool) |
24 months
|
|
% initiation of other CKD management
大体时间：24 months
|
24 months
|
|
|
Effectiveness
大体时间：24 months
|
Rates of Kidney Failure |
24 months
|
|
Effectiveness
大体时间：24 months
|
Rates of CV Death |
24 months
|
|
Effectiveness
大体时间：24 months
|
Rates adverse drug reactions |
24 months
|
|
Effectiveness
大体时间：24 months
|
Rates all-cause hospitalisations |
24 months
|
合作者和调查者
调查人员
- 首席研究员：Rathika Krishnasamy、The University of Queensland
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 25.01
- APP2054344/GACDHS10 (其他赠款/资助编号：NHMRC-GACD)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享访问标准
2 to 5 years following publication of the main study results.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.