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| Name | Class |
|---|---|
| SingHealth Polyclinics | OTHER |
| National University Polyclinics, Singapore | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multicomponent intervention | Experimental | 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. |
|
| Usual care | No Intervention | treated by physicians and nurses who are not trained in SKOPE treatment algorithms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the eGFR | from randomization to final follow-up at 36 months |
| 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 |
| 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 | |
4.3 Inclusion Criteria
4.4 Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SingHealth Polyclinics | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39472975 | Derived | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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 |
| 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:
| 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 |
| 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 |
| Incident dialysis or MACE | 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 |
| 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 |
| 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 |
| 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |