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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Rathika Krishnasamy
- Número de telefone: +61 401 696 408
- E-mail: implement-ckd@uq.edu.au
Estude backup de contato
- Nome: Laura Hickey
- E-mail: implement-ckd@uq.edu.au
Locais de estudo
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Suva, Fiji
- Ministry of Health, Fiji
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Contato:
- Anis Ta'eed
- E-mail: implement-ckd@uq.edu.au
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Contato:
- Yogeshni Chandra
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Apia, Samoa
- Department of Health, Samoa
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Contato:
- Ben Matalavea
- E-mail: lbmatalavea@nkfs.ws
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Contato:
- Malama Tafuna'i
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Bangkok, Tailândia
- Chulalongkorn University
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Contato:
- Talerngsak Kanjanabuch
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Participants will be recruited from Thailand, Fiji and Samoa.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
A Reach of 50% of eligible patients initiated on SGLT2i therapy
Prazo: 24 months
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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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence to SGLT2i therapy
Prazo: 24 months
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Patient reported uptake |
24 months
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Effectiveness
Prazo: 24 months
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Rates of CKD detection |
24 months
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Adoption
Prazo: 24 months
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% of participating centres that initiate implementation strategies. |
24 months
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|
Implementation
Prazo: 24 months
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Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
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|
Maintenance
Prazo: 24 months
|
Score for the extent of normalisation of practice (Normalisation Measure Development tool) |
24 months
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% initiation of other CKD management
Prazo: 24 months
|
24 months
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Effectiveness
Prazo: 24 months
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Rates of Kidney Failure |
24 months
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Effectiveness
Prazo: 24 months
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Rates of CV Death |
24 months
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|
Effectiveness
Prazo: 24 months
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Rates adverse drug reactions |
24 months
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Effectiveness
Prazo: 24 months
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Rates all-cause hospitalisations |
24 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rathika Krishnasamy, The University of Queensland
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25.01
- APP2054344/GACDHS10 (Número de outro subsídio/financiamento: NHMRC-GACD)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Critérios de acesso de compartilhamento IPD
2 to 5 years following publication of the main study results.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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