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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Rathika Krishnasamy
- Telefonnummer: +61 401 696 408
- E-post: implement-ckd@uq.edu.au
Studer Kontakt Backup
- Navn: Laura Hickey
- E-post: implement-ckd@uq.edu.au
Studiesteder
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Suva, Fiji
- Ministry of Health, Fiji
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Ta kontakt med:
- Anis Ta'eed
- E-post: implement-ckd@uq.edu.au
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Ta kontakt med:
- Yogeshni Chandra
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Apia, Samoa
- Department of Health, Samoa
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Ta kontakt med:
- Ben Matalavea
- E-post: lbmatalavea@nkfs.ws
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Ta kontakt med:
- Malama Tafuna'i
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Bangkok, Thailand
- Chulalongkorn University
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Ta kontakt med:
- Talerngsak Kanjanabuch
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to SGLT2i therapy
Tidsramme: 24 months
|
Patient reported uptake |
24 months
|
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Effectiveness
Tidsramme: 24 months
|
Rates of CKD detection |
24 months
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|
Adoption
Tidsramme: 24 months
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% of participating centres that initiate implementation strategies. |
24 months
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Implementation
Tidsramme: 24 months
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Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
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Maintenance
Tidsramme: 24 months
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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
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24 months
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Effectiveness
Tidsramme: 24 months
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Rates of Kidney Failure |
24 months
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Effectiveness
Tidsramme: 24 months
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Rates of CV Death |
24 months
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Effectiveness
Tidsramme: 24 months
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Rates adverse drug reactions |
24 months
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Effectiveness
Tidsramme: 24 months
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Rates all-cause hospitalisations |
24 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rathika Krishnasamy, The University of Queensland
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Sykdomsattributter
- Patologiske tilstander, tegn og symptomer
- Kardiovaskulære sykdommer
- Nyresykdommer
- Kronisk sykdom
Andre studie-ID-numre
- 25.01
- APP2054344/GACDHS10 (Annet stipend/finansieringsnummer: NHMRC-GACD)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
2 to 5 years following publication of the main study results.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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