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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Rathika Krishnasamy
- Telefoonnummer: +61 401 696 408
- E-mail: implement-ckd@uq.edu.au
Studie Contact Back-up
- Naam: Laura Hickey
- E-mail: implement-ckd@uq.edu.au
Studie Locaties
-
-
-
Suva, Fiji
- Ministry of Health, Fiji
-
Contact:
- Anis Ta'eed
- E-mail: implement-ckd@uq.edu.au
-
Contact:
- Yogeshni Chandra
-
-
-
-
-
Apia, Samoa
- Department of Health, Samoa
-
Contact:
- Ben Matalavea
- E-mail: lbmatalavea@nkfs.ws
-
Contact:
- Malama Tafuna'i
-
-
-
-
-
Bangkok, Thailand
- Chulalongkorn University
-
Contact:
- Talerngsak Kanjanabuch
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Participants will be recruited from Thailand, Fiji and Samoa.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: OTHER
- Tijdsperspectieven: PROSPECTIVE
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
A Reach of 50% of eligible patients initiated on SGLT2i therapy
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence to SGLT2i therapy
Tijdsspanne: 24 months
|
Patient reported uptake |
24 months
|
|
Effectiveness
Tijdsspanne: 24 months
|
Rates of CKD detection |
24 months
|
|
Adoption
Tijdsspanne: 24 months
|
% of participating centres that initiate implementation strategies. |
24 months
|
|
Implementation
Tijdsspanne: 24 months
|
Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
|
|
Maintenance
Tijdsspanne: 24 months
|
Score for the extent of normalisation of practice (Normalisation Measure Development tool) |
24 months
|
|
% initiation of other CKD management
Tijdsspanne: 24 months
|
24 months
|
|
|
Effectiveness
Tijdsspanne: 24 months
|
Rates of Kidney Failure |
24 months
|
|
Effectiveness
Tijdsspanne: 24 months
|
Rates of CV Death |
24 months
|
|
Effectiveness
Tijdsspanne: 24 months
|
Rates adverse drug reactions |
24 months
|
|
Effectiveness
Tijdsspanne: 24 months
|
Rates all-cause hospitalisations |
24 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rathika Krishnasamy, The University of Queensland
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Pathologische processen
- Mannelijke urogenitale ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Ziekte attributen
- Pathologische aandoeningen, tekenen en symptomen
- Hart-en vaatziekten
- Nier Ziekten
- Chronische ziekte
Andere studie-ID-nummers
- 25.01
- APP2054344/GACDHS10 (Ander subsidie-/financieringsnummer: NHMRC-GACD)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-toegangscriteria voor delen
2 to 5 years following publication of the main study results.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .