Actively Recruiting

Phase Not Applicable
Age: 40Years - 79Years
All Genders
NCT05295368

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

Age: 40Years - 79Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

SingHealth Polyclinics

Singapore, Singapore

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here