Evaluating strategies to preserve kidney function in patients with chronic kidney disease
Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study
This study is testing a new approach that includes health coaching and lifestyle changes to see if it can help people with chronic kidney disease keep their kidneys working better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 896 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | Duke-NUS Graduate Medical School Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05295368 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the effectiveness and cost-effectiveness of a multicomponent primary care intervention designed to preserve kidney function in patients with chronic kidney disease (CKD) at primary care clinics in Singapore. It will involve a pragmatic, randomized controlled design across four diverse polyclinics, enrolling 896 participants aged 40 to 80 with CKD Stage 3 or worse. Participants will be randomly assigned to either the intervention group, which includes health coaching and lifestyle modifications, or the usual care group. The study will span three years, focusing on improving patient outcomes in CKD management.
Who should consider this trial
Good fit: Ideal candidates are Singaporean or permanent resident patients aged 40 to 80 with CKD Stage 3 or 4 who have been receiving care at the polyclinics for at least one year.
Not a fit: Patients on kidney replacement therapy, those with terminal illnesses, or individuals unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney health and quality of life for patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promise in using multicomponent interventions for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
4.3 Inclusion Criteria * Patients with CKD Stage 3 or Stage 4 defined as persistent reduction in Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula eGFR ≥15 and \< 60 ml/min/1.73m2 for at least 3 months based on two eGFR readings at least 3 months apart and the last eGFR should be measured at least 3 months ago. * Receiving care at the polyclinics in Singapore for at least one year at the time of recruitment * Age \>=40 and \<80 years * Singaporean or permanent resident 4.4 Exclusion Criteria * On kidney replacement therapy * Pregnancy or breastfeeding * Known terminal illness * Recent hospitalization during last 3 months * History of leg or foot ulcers, severe mental illness, prior kidney transplant * Inability to provide informed consent
Where this trial is running
Singapore
- SingHealth Polyclinics — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Tazeen H. Jafar, MBBS, MPH, FASN
- Email: tazeen.jafar@duke-nus.edu.sg
- Phone: +65 66012582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.