Clinical trial NCT05295368: Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study
Official title: Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
clinical trial
primary care
kidney function
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 896
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: the eGFR
timeFrame: from randomization to final follow-up at 36 months
Secondary outcomes:
measure: Mean change in CVD risk score
timeFrame: at 12, 24, and 36 months from the baseline
measure: Mean change in CKD quality of life
timeFrame: at 12, 24, and 36 months from the baseline
measure: Mean change in CKD quality of life
timeFrame: at 12, 24, and 36 months from the baseline
Other outcomes:
measure: Incident eGFR <30 ml/min/1.73m2
timeFrame: from randomization to final follow-up at 36 months
measure: Incident eGFR <45 ml/min/1.73m2;
timeFrame: from randomization to final follow-up at 36 months
measure: Incident eGFR <15 ml/min/1.73m2;
timeFrame: from randomization to final follow-up at 36 months
measure: Incident ACR >300 mg/g;
timeFrame: from randomization to final follow-up at 36 months
measure: Incident dialysis
timeFrame: from randomization to final follow-up at 36 months
measure: Rate of MACE (composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in kidney failure risk equation ( KFRE) score
timeFrame: from randomization to final follow-up at 36 months
measure: Proportion of subjects who experienced albuminuria defined as ACR >30 mg/g
timeFrame: from randomization to final follow-up at 36 months
measure: Rate of All-cause mortality
timeFrame: from randomization to final follow-up at 36 months
measure: Rate of CVD deaths
timeFrame: from randomization to final follow-up at 36 months
measure: Rate of hospital admission due to CHD, heart failure, or stroke
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in Dietary score
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in level of physical activity
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in BMI
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in adherence to antihypertensive
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in adherence to glucose-lowering medication
timeFrame: from randomization to final follow-up at 36 months
measure: 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)
timeFrame: from randomization to final follow-up at 36 months
measure: Mean change in Framingham risk score
timeFrame: from randomization to final follow-up at 36 months
measure: Proportion of subjects with at least 40% decline in baseline eGFR or kidney replacement therapy ( KRT) with mortality
timeFrame: from randomization to final follow-up at 36 months
measure: b) Proportion of subjects with at least 40% decline in baseline eGFR or KRT without mortality
timeFrame: from randomization to final follow-up at 36 months
measure: c) Proportion of subjects with at least 50% decline in baseline eGFR or KRT with mortality
timeFrame: from randomization to final follow-up at 36 months
measure: d) Proportion of subjects with at least 50% decline in baseline eGFR or KRT without mortality
timeFrame: from randomization to final follow-up at 36 months
Locations:
city: Singapore
country: Singapore
facility: SingHealth Polyclinics
Study officials:
References: