Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study (SKOPE)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Multicomponent intervention

• Study Type: Interventional
• Enrollment (Estimated): 724
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • SingHealth Polyclinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Multicomponent intervention; 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.
No Intervention: Usual care; treated by physicians and nurses who are not trained in SKOPE treatment algorithms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the eGFR	from randomization to final follow-up at 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in CVD risk score	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	at 12, 24, and 36 months from the baseline
Mean change in CKD quality of life	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).	at 12, 24, and 36 months from the baseline
guideline-directed medical therapy (GDMT) goals	Attained more than 2 guideline-directed medical therapy (GDMT) goals; Attained more than 3 GDMT goals; Attained more than 4 GDMT goals	at 12, 24, and 36 months from the baseline
Individual guideline-directed medical therapy (GDMT) goals	Proportion of participants in each arm who experienced each of the following categories of events on or before month 12, 24, and 36 follow up: SBP/DBP<140/90 mmHg; SBP/DBP<130/80 mmHg; A1C<7.0%; Taking statin medications; Taking RASS blockers medications; Taking SGLT2i medications; Not smoking	at 12, 24, and 36 months from the baseline
MoCA score	continuous outcome	at 36 months from the baseline
Mild cognitive impairment	Proportion of mild cognitive impairment determined by local norms of MoCA (cutpoint:24/25)	at 36 months from the baseline
Handgrip strength	Measured by dynamometer	at 36 months from the baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incident ACR >300 mg/g;		from randomization to final follow-up at 36 months
Rate of MACE (composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure		from randomization to final follow-up at 36 months
Mean change in kidney failure risk equation ( KFRE) score	The score is based on an equation not on 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	from randomization to final follow-up at 36 months
Proportion of subjects who experienced albuminuria defined as ACR >30 mg/g	defined as ACR >30 mg/g	from randomization to final follow-up at 36 months
Rate of All-cause mortality		from randomization to final follow-up at 36 months
Rate of CVD deaths		from randomization to final follow-up at 36 months
Rate of hospital admission due to CHD, heart failure, or stroke		from randomization to final follow-up at 36 months
Mean change in Dietary score	Not based on a scale, higher score indicates better outcome	from randomization to final follow-up at 36 months
Mean change in level of physical activity	International Physical Activity Questionnaire (PHAQ): there is no range, higher scores denote higher levels of physical activities	from randomization to final follow-up at 36 months
Mean change in BMI		from randomization to final follow-up at 36 months
Mean change in adherence to antihypertensive		from randomization to final follow-up at 36 months
Mean change in adherence to glucose-lowering medication		from randomization to final follow-up at 36 months
Mean change from baseline in therapeutic intensity score of antihypertensive medication (all and class specific) therapeutic intensity score (summary measure that accounts for the number of medications and the relative doses a patient received)	summary measure that accounts for the number of medications and the relative doses a patient received. Higher scores indicate higher dose.	from randomization to final follow-up at 36 months
b) Proportion of subjects with at least 40% decline in baseline eGFR or KRT without mortality		from randomization to final follow-up at 36 months
Incident dialysis or MACE		from randomization to final follow-up at 36 months
Mean change from baseline in CVD risk based on Predicting Risk of Cardiovascular Disease EVENTs (PRVENT) equation	based on an equation, Results are given as a percent (%) on a scale of less than 1% to 99.99%. A higher score indicates a higher risk	from randomization to final follow-up at 36 months
at least 40% decline from baseline eGFR or underwent KRT or experienced mortality		from randomization to final follow-up at 36 months
at least 50% decline from baseline eGFR or underwent KRT or experienced mortality		from randomization to final follow-up at 36 months
at least 50% decline from baseline eGFR or underwent KRT		from randomization to final follow-up at 36 months
underwent KRT with mortality		from randomization to final follow-up at 36 months
underwent KRT with or without mortality		from randomization to final follow-up at 36 months
Proportion of subjects who experienced LDL-C <100 mg/dL		month 12, 24, and 36 follow ups.

Collaborators and Investigators

• Sponsor: Duke-NUS Graduate Medical School
• Collaborators: National University Polyclinics, Singapore; SingHealth Polyclinics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: primary care; chronic kidney disease; clinical trial; kidney function
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: CSASI20nov-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No