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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Rathika Krishnasamy
- 전화번호: +61 401 696 408
- 이메일: implement-ckd@uq.edu.au
연구 연락처 백업
- 이름: Laura Hickey
- 이메일: implement-ckd@uq.edu.au
연구 장소
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Apia, 사모아
- Department of Health, Samoa
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연락하다:
- Ben Matalavea
- 이메일: lbmatalavea@nkfs.ws
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연락하다:
- Malama Tafuna'i
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Bangkok, 태국
- Chulalongkorn University
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연락하다:
- Talerngsak Kanjanabuch
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Suva, 피지
- Ministry of Health, Fiji
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연락하다:
- Anis Ta'eed
- 이메일: implement-ckd@uq.edu.au
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연락하다:
- Yogeshni Chandra
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants will be recruited from Thailand, Fiji and Samoa.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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A Reach of 50% of eligible patients initiated on SGLT2i therapy
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adherence to SGLT2i therapy
기간: 24 months
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Patient reported uptake |
24 months
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Effectiveness
기간: 24 months
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Rates of CKD detection |
24 months
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Adoption
기간: 24 months
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% of participating centres that initiate implementation strategies. |
24 months
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Implementation
기간: 24 months
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Acceptability and feasibility of implementation strategies. Fidelity to protocol |
24 months
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Maintenance
기간: 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
기간: 24 months
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24 months
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Effectiveness
기간: 24 months
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Rates of Kidney Failure |
24 months
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Effectiveness
기간: 24 months
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Rates of CV Death |
24 months
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Effectiveness
기간: 24 months
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Rates adverse drug reactions |
24 months
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Effectiveness
기간: 24 months
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Rates all-cause hospitalisations |
24 months
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Rathika Krishnasamy, The University of Queensland
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 25.01
- APP2054344/GACDHS10 (기타 보조금/기금 번호: NHMRC-GACD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 액세스 기준
2 to 5 years following publication of the main study results.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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