A randomized controlled trial is set to evaluate the effectiveness of a structured multicomponent intervention (MCI) named SKOPE in managing kidney outcomes among patients with chronic kidney disease (CKD) in Singapore. The study aims to determine if the SKOPE interventions can be adopted into clinical practice for patients with CKD.
The intervention consists of four key components:
Training for Healthcare Providers
Nurses and service coordinators will be trained as health coaches, utilizing a hybrid follow-up approach involving in-person, telephone, and secure video sessions. This training will cover motivational conversation, nutritional assessment, lifestyle counseling, and self-care for the prevention of CKD and cardiovascular disease (CVD). Physicians will also receive training in algorithm-based standardized management of CKD, based on Kidney Disease Improving Global Outcomes (KDIGO) guidelines, and hybrid care delivery.
Standardized Treatment Protocol
A standardized treatment protocol based on KDIGO guidelines will be implemented, including risk stratification for end-stage kidney disease (ESKD) using the Southeast Asia Kidney Failure Risk Equation (SEA KFRE). The target blood pressure will be <130/80 mm Hg, with consideration for lower targets in patients with higher albumin-to-creatinine ratio (ACR). The protocol includes recommendations for renin–angiotensin–aldosterone system (RAAS) blockers, diuretics, and statins. SGLT2 inhibitors will be recommended for patients with eGFR ≥30 ml/min/1.73 m2 and either diabetes or ACR ≥30 mg/mmol.
Regular Case Review Meetings
Regular CKD case review meetings will be held among trained nurses/service coordinators (health coaches), dieticians, and trained physicians to review patient progress and CKD care plans.
SGLT2i Subsidies
Patients in the intervention arm who take SGLT2i (e.g., dapagliflozin or empagliflozin) as prescribed will receive a $30 voucher annually.
Trial Design and Outcomes
The trial will compare the SKOPE intervention against usual care, where physicians and nurses not trained in SKOPE treatment algorithms will treat patients. The primary outcome will be the eGFR total slope from randomization to final follow-up at 36 months. Secondary outcomes include mean change in CVD risk score, quality of life, and the proportion of patients receiving guideline-recommended therapies such as SGLT2i, RAAS blockers, and statins.
Sample Size and Recruitment
The study plans to recruit 896 participants from polyclinics in Singapore. The sample size is calculated to detect a conservative effect size of at least 0.21 for the intervention on eGFR slopes, with 80% power at a two-sided 5% significance level.
