Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

Chronic Kidney Diseases Clinical Trial

— SKOPE  

Official title:

Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295368
• Other study ID #: CSASI20nov-0001
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: June 2026

Study information

• Verified date: August 2022
• Source: Duke-NUS Graduate Medical School
• Contact: Tazeen H. Jafar, MBBS, MPH, FASN
• Phone: +65 66012582
• Email: tazeen.jafar[@]duke-nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 896
• Est. completion date: June 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Singapore	SingHealth Polyclinics	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incident eGFR <30 ml/min/1.73m2		from randomization to final follow-up at 36 months
Other	Incident eGFR <45 ml/min/1.73m2;		from randomization to final follow-up at 36 months
Other	Incident eGFR <15 ml/min/1.73m2;		from randomization to final follow-up at 36 months
Other	Incident ACR >300 mg/g;		from randomization to final follow-up at 36 months
Other	Incident dialysis		from randomization to final follow-up at 36 months
Other	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
Other	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
Other	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
Other	Rate of All-cause mortality		from randomization to final follow-up at 36 months
Other	Rate of CVD deaths		from randomization to final follow-up at 36 months
Other	Rate of hospital admission due to CHD, heart failure, or stroke		from randomization to final follow-up at 36 months
Other	Mean change in Dietary score	Not based on a scale, higher score indicates better outcome	from randomization to final follow-up at 36 months
Other	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
Other	Mean change in BMI		from randomization to final follow-up at 36 months
Other	Mean change in adherence to antihypertensive		from randomization to final follow-up at 36 months
Other	Mean change in adherence to glucose-lowering medication		from randomization to final follow-up at 36 months
Other	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
Other	Mean change in Framingham risk score	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
Other	Proportion of subjects with at least 40% decline in baseline eGFR or kidney replacement therapy ( KRT) with mortality		from randomization to final follow-up at 36 months
Other	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
Other	c) Proportion of subjects with at least 50% decline in baseline eGFR or KRT with mortality		from randomization to final follow-up at 36 months
Other	d) Proportion of subjects with at least 50% decline in baseline eGFR or KRT without mortality		from randomization to final follow-up at 36 months
Primary	the eGFR		from randomization to final follow-up at 36 months
Secondary	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
Secondary	Mean change in CKD quality of life	Assessed by Kidney Disease Quality of Life 36-item short form survey(KDQOL-36TM), score ranges from 0 to 100, higher scores dente better quality of life	at 12, 24, and 36 months from the baseline
Secondary	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