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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Rathika Krishnasamy
- Telefonnummer: +61 401 696 408
- E-post: implement-ckd@uq.edu.au
Studera Kontakt Backup
- Namn: Laura Hickey
- E-post: implement-ckd@uq.edu.au
Studieorter
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-
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Suva, Fiji
- Ministry of Health, Fiji
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Kontakt:
- Anis Ta'eed
- E-post: implement-ckd@uq.edu.au
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Kontakt:
- Yogeshni Chandra
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-
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-
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Apia, Samoa
- Department of Health, Samoa
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Kontakt:
- Ben Matalavea
- E-post: 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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Participants will be recruited from Thailand, Fiji and Samoa.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
A Reach of 50% of eligible patients initiated on SGLT2i therapy
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adherence to SGLT2i therapy
Tidsram: 24 months
|
Patient reported uptake |
24 months
|
|
Effectiveness
Tidsram: 24 months
|
Rates of CKD detection |
24 months
|
|
Adoption
Tidsram: 24 months
|
% of participating centres that initiate implementation strategies. |
24 months
|
|
Implementation
Tidsram: 24 months
|
Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
|
|
Maintenance
Tidsram: 24 months
|
Score for the extent of normalisation of practice (Normalisation Measure Development tool) |
24 months
|
|
% initiation of other CKD management
Tidsram: 24 months
|
24 months
|
|
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Effectiveness
Tidsram: 24 months
|
Rates of Kidney Failure |
24 months
|
|
Effectiveness
Tidsram: 24 months
|
Rates of CV Death |
24 months
|
|
Effectiveness
Tidsram: 24 months
|
Rates adverse drug reactions |
24 months
|
|
Effectiveness
Tidsram: 24 months
|
Rates all-cause hospitalisations |
24 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Rathika Krishnasamy, The University of Queensland
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25.01
- APP2054344/GACDHS10 (Annat bidrag/finansieringsnummer: NHMRC-GACD)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Kriterier för IPD Sharing Access
2 to 5 years following publication of the main study results.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
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