Chronic Kidney Diseases
Conditions
Keywords
chronic kidney disease, clinical trial, primary care, kidney function
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
Interventions
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.
Sponsors
Duke-NUS Graduate Medical School
SingHealth Polyclinics
National University Polyclinics, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the eGFR | from randomization to final follow-up at 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| guideline-directed medical therapy (GDMT) goals | at 12, 24, and 36 months from the baseline | 1. Attained more than 2 guideline-directed medical therapy (GDMT) goals 2. Attained more than 3 GDMT goals 3. Attained more than 4 GDMT goals |
| Individual guideline-directed medical therapy (GDMT) goals | at 12, 24, and 36 months from the baseline | 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: 1. SBP/DBP\<140/90 mmHg 2. SBP/DBP\<130/80 mmHg 3. A1C\<7.0% 4. Taking statin medications 5. Taking RASS blockers medications 6. Taking SGLT2i medications 7. Not smoking |
| MoCA score | at 36 months from the baseline | continuous outcome |
| Mild cognitive impairment | at 36 months from the baseline | Proportion of mild cognitive impairment determined by local norms of MoCA (cutpoint:24/25) |
| Handgrip strength | at 36 months from the baseline | Measured by dynamometer |
Countries
Singapore
Outcome results
None listed