Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Other: Multicomponent intervention

• Registration Number: NCT05295368
• Lead Sponsor: Duke-NUS Graduate Medical School

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-25
• Study Start: 2022-07-21
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12
• Primary Completion: 2025-08
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 896

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multicomponent intervention	Multicomponent intervention	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.

Primary Outcome Measures

Name	Time	Method
the eGFR	from randomization to final follow-up at 36 months

Secondary Outcome Measures

Name	Time	Method
Mean change in CVD risk score	at 12, 24, and 36 months from the baseline	measured by The Million Hearts Longitudinal atherosclerotic cardiovascular disease(ASCVD) Risk Assessment score:not assessed via a scale. Results are given as a percent (%) on a scale of less than 1% to 99.99%. A higher score indicates a higher risk
Mean change in CKD quality of life	at 12, 24, and 36 months from the baseline	Assessed by The 5-level EuroQol-5D version (EQ-5D-5L):Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Trial Locations

Locations (1)

SingHealth Polyclinics; 🇸🇬 Singapore, Singapore