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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Rathika Krishnasamy
- Telefonnummer: +61 401 696 408
- E-mail: implement-ckd@uq.edu.au
Undersøgelse Kontakt Backup
- Navn: Laura Hickey
- E-mail: implement-ckd@uq.edu.au
Studiesteder
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Suva, Fiji
- Ministry of Health, Fiji
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Kontakt:
- Anis Ta'eed
- E-mail: implement-ckd@uq.edu.au
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Kontakt:
- Yogeshni Chandra
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Apia, Samoa
- Department of Health, Samoa
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Kontakt:
- Ben Matalavea
- E-mail: lbmatalavea@nkfs.ws
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Kontakt:
- Malama Tafuna'i
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Bangkok, Thailand
- Chulalongkorn University
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Kontakt:
- Talerngsak Kanjanabuch
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Participants will be recruited from Thailand, Fiji and Samoa.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
A Reach of 50% of eligible patients initiated on SGLT2i therapy
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to SGLT2i therapy
Tidsramme: 24 months
|
Patient reported uptake |
24 months
|
|
Effectiveness
Tidsramme: 24 months
|
Rates of CKD detection |
24 months
|
|
Adoption
Tidsramme: 24 months
|
% of participating centres that initiate implementation strategies. |
24 months
|
|
Implementation
Tidsramme: 24 months
|
Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
|
|
Maintenance
Tidsramme: 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
Tidsramme: 24 months
|
24 months
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Effectiveness
Tidsramme: 24 months
|
Rates of Kidney Failure |
24 months
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Effectiveness
Tidsramme: 24 months
|
Rates of CV Death |
24 months
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|
Effectiveness
Tidsramme: 24 months
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Rates adverse drug reactions |
24 months
|
|
Effectiveness
Tidsramme: 24 months
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Rates all-cause hospitalisations |
24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Rathika Krishnasamy, The University of Queensland
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25.01
- APP2054344/GACDHS10 (Andet bevillings-/finansieringsnummer: NHMRC-GACD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingsadgangskriterier
2 to 5 years following publication of the main study results.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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