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

Abstract Background Chronic kidney disease (CKD) poses a global health challenge with high morbidity and mortality rates. Early detection and prompt intervention are critical in preventing progression to end-stage kidney disease (ESKD) and cardiovascular complications. Effective CKD management requi...

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Main Authors: Tazeen Hasan Jafar, Ngiap Chuan Tan, Mihir Gandhi, Sungwon Yoon, Eric Finkelstein, Peter Moey Kirm Seng, Ruiheng Ong, Anandan Gerard Thiagarajah, Bing Long Lee, Ka Chi To, Aminath Shiwaza Moosa
Format: Article
Language:English
Published: BMC 2024-10-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-024-08564-1
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author Tazeen Hasan Jafar
Ngiap Chuan Tan
Mihir Gandhi
Sungwon Yoon
Eric Finkelstein
Peter Moey Kirm Seng
Ruiheng Ong
Anandan Gerard Thiagarajah
Bing Long Lee
Ka Chi To
Aminath Shiwaza Moosa
author_facet Tazeen Hasan Jafar
Ngiap Chuan Tan
Mihir Gandhi
Sungwon Yoon
Eric Finkelstein
Peter Moey Kirm Seng
Ruiheng Ong
Anandan Gerard Thiagarajah
Bing Long Lee
Ka Chi To
Aminath Shiwaza Moosa
author_sort Tazeen Hasan Jafar
collection DOAJ
description Abstract Background Chronic kidney disease (CKD) poses a global health challenge with high morbidity and mortality rates. Early detection and prompt intervention are critical in preventing progression to end-stage kidney disease (ESKD) and cardiovascular complications. Effective CKD management requires comprehensive care packages that integrate both pharmacological and non-pharmacological interventions within collaborative, team-based models, aiming to enhance patient outcomes and overall quality of life. The goal of the Strategies for Kidney Outcomes Prevention and Evaluation (SKOPE) study is to establish effective multicomponent intervention (MCI) strategies for evaluating and preventing kidney outcomes in patients with moderate to advanced CKD within primary care settings in Singapore. Methods This study is a 3-year randomized controlled trial among 896 participants aged between 40 and 80 years with moderate or advanced CKD in five government-subsidized polyclinics in Singapore. The components of the MCI are (1) nurses/service coordinators trained as health coaches for motivational conversation and CKD-specific lifestyle counseling on diet and exercise, using a hybrid follow-up approach of in-person, telephone, and secure video meetings; (2) training physicians in algorithm-based standardized management of CKD; (3) subsidy on SGLT2i medications for CKD; and (4) regular CKD case review meetings. The primary outcome is the estimated glomerular filtration rate (eGFR) total slope from randomization to final follow-up at 36 months. Discussion If shown to be effective, cost-effective, and acceptable, SKOPE should be considered for scaling country-wide and in similar regional healthcare systems. Trial registration ClinicalTrials.gov NCT05295368. Registered on March 25, 2022.
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spelling doaj-art-d7657f697d854a28b1d3594e862bf3c62025-01-05T12:45:13ZengBMCTrials1745-62152024-10-0125111710.1186/s13063-024-08564-1Evaluating 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 trialTazeen Hasan Jafar0Ngiap Chuan Tan1Mihir Gandhi2Sungwon Yoon3Eric Finkelstein4Peter Moey Kirm Seng5Ruiheng Ong6Anandan Gerard Thiagarajah7Bing Long Lee8Ka Chi To9Aminath Shiwaza Moosa10Program in Health Services & Systems Research, Duke–NUS Medical SchoolSingHealth PolyclinicsCentre for Quantitative Medicine, Duke-NUS Medical SchoolProgram in Health Services & Systems Research, Duke–NUS Medical SchoolProgram in Health Services & Systems Research, Duke–NUS Medical SchoolSingHealth PolyclinicsSingHealth PolyclinicsNational University PolyclinicsNational University PolyclinicsNational University PolyclinicsSingHealth PolyclinicsAbstract Background Chronic kidney disease (CKD) poses a global health challenge with high morbidity and mortality rates. Early detection and prompt intervention are critical in preventing progression to end-stage kidney disease (ESKD) and cardiovascular complications. Effective CKD management requires comprehensive care packages that integrate both pharmacological and non-pharmacological interventions within collaborative, team-based models, aiming to enhance patient outcomes and overall quality of life. The goal of the Strategies for Kidney Outcomes Prevention and Evaluation (SKOPE) study is to establish effective multicomponent intervention (MCI) strategies for evaluating and preventing kidney outcomes in patients with moderate to advanced CKD within primary care settings in Singapore. Methods This study is a 3-year randomized controlled trial among 896 participants aged between 40 and 80 years with moderate or advanced CKD in five government-subsidized polyclinics in Singapore. The components of the MCI are (1) nurses/service coordinators trained as health coaches for motivational conversation and CKD-specific lifestyle counseling on diet and exercise, using a hybrid follow-up approach of in-person, telephone, and secure video meetings; (2) training physicians in algorithm-based standardized management of CKD; (3) subsidy on SGLT2i medications for CKD; and (4) regular CKD case review meetings. The primary outcome is the estimated glomerular filtration rate (eGFR) total slope from randomization to final follow-up at 36 months. Discussion If shown to be effective, cost-effective, and acceptable, SKOPE should be considered for scaling country-wide and in similar regional healthcare systems. Trial registration ClinicalTrials.gov NCT05295368. Registered on March 25, 2022.https://doi.org/10.1186/s13063-024-08564-1Chronic kidney diseaseEstimated glomerular filtration rateQuality of lifeCardiovascularMulticomponent interventionMotivational counseling
spellingShingle Tazeen Hasan Jafar
Ngiap Chuan Tan
Mihir Gandhi
Sungwon Yoon
Eric Finkelstein
Peter Moey Kirm Seng
Ruiheng Ong
Anandan Gerard Thiagarajah
Bing Long Lee
Ka Chi To
Aminath Shiwaza Moosa
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
Chronic kidney disease
Estimated glomerular filtration rate
Quality of life
Cardiovascular
Multicomponent intervention
Motivational counseling
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Chronic kidney disease
Estimated glomerular filtration rate
Quality of life
Cardiovascular
Multicomponent intervention
Motivational counseling
url https://doi.org/10.1186/s13063-024-08564-1
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