Actively Recruiting
Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study
Led by Duke-NUS Graduate Medical School · Updated on 2022-08-12
896
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Chronic kidney disease (CKD) is a major public health threat associated with significant morbidity, high mortality, and reduced quality of life. However, empirical evidence is limited on strategies to enhance the effectiveness of care for CKD. The objective of the trial is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies in preserving kidney function among patients with CKD at primary care clinics in Singapore. Methods: A pragmatic, randomized controlled trial, in 4 socioeconomically diverse primary care clinics (polyclinics) in Singapore over 3 years. A total of 896 participants with CKD Stage 3 or worse aged ≥40 and \<80 years will be enrolled, with 224 from each polyclinic. Participants enrolled in each polyclinic will be randomly allocated to the intervention or usual care group in a 1:1 ratio. Intervention includes four components 1) training nurses as health coaches for motivational conversation and CKD specific lifestyle counseling on diet and exercise, using hybrid follow-up approach of in-person, telephone, and secure WhatsApp video meetings; 2)Training physicians in algorithm-based standardized management of CKD and hybrid care delivery;3) subsidy on sodium-glucose transport protein-2 inhibitors (SGLT-2i) for CKD; and 4) regular CKD case review meetings. Patients in the usual care arm will be treated by physicians and nurses who and are not trained in SKOPE treatment algorithms. Study outcomes: The primary outcome will be the eGFR total slope from randomization to final follow-up at 36 months. secondary effectiveness outcomes will be 1) Change in CVD risk score as measured by The Million Hearts Longitudinal ASCVD Risk Assessment score 2) Change in CKD quality of life measured by KDQOL-36TM
CONDITIONS
Official Title
Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with CKD Stage 3 or Stage 4 defined as persistent reduction in eGFR 4 60 ml/min/1.73m2 for at least 3 months based on two eGFR readings 3 months apart and last eGFR measured at least 3 months ago
- Receiving care at polyclinics in Singapore for at least one year at time of recruitment
- Age 40 years or older and under 80 years
- Singaporean or permanent resident
You will not qualify if you...
- On kidney replacement therapy
- Pregnancy or breastfeeding
- Known terminal illness
- Recent hospitalization in the last 3 months
- History of leg or foot ulcers, severe mental illness, or prior kidney transplant
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SingHealth Polyclinics
Singapore, Singapore
Actively Recruiting
Research Team
T
Tazeen H. Jafar, MBBS, MPH, FASN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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