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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rathika Krishnasamy
- Numéro de téléphone: +61 401 696 408
- E-mail: implement-ckd@uq.edu.au
Sauvegarde des contacts de l'étude
- Nom: Laura Hickey
- E-mail: implement-ckd@uq.edu.au
Lieux d'étude
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Suva, Fidji
- Ministry of Health, Fiji
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Contact:
- Anis Ta'eed
- E-mail: implement-ckd@uq.edu.au
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Contact:
- Yogeshni Chandra
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Apia, Samoa
- Department of Health, Samoa
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Contact:
- Ben Matalavea
- E-mail: lbmatalavea@nkfs.ws
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Contact:
- Malama Tafuna'i
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Bangkok, Thaïlande
- Chulalongkorn University
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Contact:
- Talerngsak Kanjanabuch
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Participants will be recruited from Thailand, Fiji and Samoa.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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A Reach of 50% of eligible patients initiated on SGLT2i therapy
Délai: 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence to SGLT2i therapy
Délai: 24 months
|
Patient reported uptake |
24 months
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Effectiveness
Délai: 24 months
|
Rates of CKD detection |
24 months
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Adoption
Délai: 24 months
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% of participating centres that initiate implementation strategies. |
24 months
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Implementation
Délai: 24 months
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Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
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Maintenance
Délai: 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
Délai: 24 months
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24 months
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Effectiveness
Délai: 24 months
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Rates of Kidney Failure |
24 months
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Effectiveness
Délai: 24 months
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Rates of CV Death |
24 months
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Effectiveness
Délai: 24 months
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Rates adverse drug reactions |
24 months
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Effectiveness
Délai: 24 months
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Rates all-cause hospitalisations |
24 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rathika Krishnasamy, The University of Queensland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Attributs de la maladie
- Conditions pathologiques, signes et symptômes
- Maladies cardiovasculaires
- Maladies rénales
- Maladie chronique
Autres numéros d'identification d'étude
- 25.01
- APP2054344/GACDHS10 (Autre subvention/numéro de financement: NHMRC-GACD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Critères d'accès au partage IPD
2 to 5 years following publication of the main study results.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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