Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

NCT05295368 | Recruiting DMC

• 1 other identifier: CSASI20nov-0001
• Study Type: interventional
• Target: 896
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Kidney Diseases

Keywords

chronic kidney disease; clinical trial; primary care; kidney function

Outcome Measures

Primary Outcomes (1)

• the eGFR

  from randomization to final follow-up at 36 months

Secondary Outcomes (3)

• Mean change in CVD risk score

  at 12, 24, and 36 months from the baseline

• Mean change in CKD quality of life

  at 12, 24, and 36 months from the baseline

• Mean change in CKD quality of life

  at 12, 24, and 36 months from the baseline

Other Outcomes (22)

• Incident eGFR <30 ml/min/1.73m2

  from randomization to final follow-up at 36 months

• Incident eGFR <45 ml/min/1.73m2;

  from randomization to final follow-up at 36 months

• Incident eGFR <15 ml/min/1.73m2;

  from randomization to final follow-up at 36 months

Study Arms (2)

multicomponent intervention

EXPERIMENTAL

1\) 1. Training Nurses/service coordinators as Health Coaches and Hybrid Follow-up Approach of in-person, Telephone and Secure Video Sessions; 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.

Other: Multicomponent intervention

Usual care

NO INTERVENTION

treated by physicians and nurses who are not trained in SKOPE treatment algorithms.

Interventions

Multicomponent intervention OTHER

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 video sessions; 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.

multicomponent intervention

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead

Study Sites (1)

SingHealth Polyclinics

Singapore, Singapore

RECRUITING

Related Publications (1)

• Jafar TH, Tan NC, Gandhi M, Yoon S, Finkelstein E, Seng PMK, Ong R, Thiagarajah AG, Lee BL, To KC, Moosa AS. Evaluating a multicomponent intervention for managing kidney outcomes among patients with moderate or advanced chronic kidney disease (CKD): protocol for the Strategies for Kidney Outcomes Prevention and Evaluation (SKOPE) randomized controlled trial. Trials. 2024 Oct 30;25(1):730. doi: 10.1186/s13063-024-08564-1.

  PMID: 39472975 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tazeen H. Jafar, MBBS, MPH, FASN

CONTACT

+65 66012582; tazeen.jafar@duke-nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 25, 2022
• Study Start: July 21, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)