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NCT Number: NCT05295368

Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

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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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SingHealth Polyclinics

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. the eGFR

    Time frame: from randomization to final follow-up at 36 months

Secondary outcomes

  1. Mean change in CVD risk score

    Time frame: 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

  2. Mean change in CKD quality of life

    Time frame: 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).

  3. guideline-directed medical therapy (GDMT) goals

    Time frame: at 12, 24, and 36 months from the baseline

    • Attained more than 2 guideline-directed medical therapy (GDMT) goals
    • Attained more than 3 GDMT goals
    • Attained more than 4 GDMT goals

  4. Individual guideline-directed medical therapy (GDMT) goals

    Time frame: 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:

    • SBP/DBP<140/90 mmHg
    • SBP/DBP<130/80 mmHg
    • A1C<7.0%
    • Taking statin medications
    • Taking RASS blockers medications
    • Taking SGLT2i medications
    • Not smoking

  5. MoCA score

    Time frame: at 36 months from the baseline

    continuous outcome

  6. Mild cognitive impairment

    Time frame: at 36 months from the baseline

    Proportion of mild cognitive impairment determined by local norms of MoCA (cutpoint:24/25)

  7. Handgrip strength

    Time frame: at 36 months from the baseline

    Measured by dynamometer

Other outcomes

  1. Incident eGFR <30 ml/min/1.73m2

    Time frame: from randomization to final follow-up at 36 months

  2. Incident eGFR <45 ml/min/1.73m2;

    Time frame: from randomization to final follow-up at 36 months

  3. Incident eGFR <15 ml/min/1.73m2;

    Time frame: from randomization to final follow-up at 36 months

  4. Incident ACR >300 mg/g;

    Time frame: from randomization to final follow-up at 36 months

  5. Incident dialysis or MACE

    Time frame: from randomization to final follow-up at 36 months

  6. Rate of MACE (composite of total death, myocardial infarction, coronary revascularization, stroke, and hospitalization because of heart failure

    Time frame: from randomization to final follow-up at 36 months

  7. Mean change in kidney failure risk equation ( KFRE) score

    Time frame: from randomization to final follow-up at 36 months

    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

  8. Proportion of subjects who experienced albuminuria defined as ACR >30 mg/g

    Time frame: from randomization to final follow-up at 36 months

    defined as ACR >30 mg/g

  9. Rate of All-cause mortality

    Time frame: from randomization to final follow-up at 36 months

  10. Rate of CVD deaths

    Time frame: from randomization to final follow-up at 36 months

  11. Rate of hospital admission due to CHD, heart failure, or stroke

    Time frame: from randomization to final follow-up at 36 months

  12. Mean change in Dietary score

    Time frame: from randomization to final follow-up at 36 months

    Not based on a scale, higher score indicates better outcome

  13. Mean change in level of physical activity

    Time frame: from randomization to final follow-up at 36 months

    International Physical Activity Questionnaire (PHAQ): there is no range, higher scores denote higher levels of physical activities

  14. Mean change in BMI

    Time frame: from randomization to final follow-up at 36 months

  15. Mean change in adherence to antihypertensive

    Time frame: from randomization to final follow-up at 36 months

  16. Mean change in adherence to glucose-lowering medication

    Time frame: from randomization to final follow-up at 36 months

  17. 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)

    Time frame: from randomization to final follow-up at 36 months

    summary measure that accounts for the number of medications and the relative doses a patient received. Higher scores indicate higher dose.

  18. Mean change from baseline in CVD risk based on Predicting Risk of Cardiovascular Disease EVENTs (PRVENT) equation

    Time frame: from randomization to final follow-up at 36 months

    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

  19. at least 40% decline from baseline eGFR or underwent KRT or experienced mortality

    Time frame: from randomization to final follow-up at 36 months

  20. b) Proportion of subjects with at least 40% decline in baseline eGFR or KRT without mortality

    Time frame: from randomization to final follow-up at 36 months

  21. at least 50% decline from baseline eGFR or underwent KRT or experienced mortality

    Time frame: from randomization to final follow-up at 36 months

  22. at least 50% decline from baseline eGFR or underwent KRT

    Time frame: from randomization to final follow-up at 36 months

  23. underwent KRT with mortality

    Time frame: from randomization to final follow-up at 36 months

  24. underwent KRT with or without mortality

    Time frame: from randomization to final follow-up at 36 months

  25. Proportion of subjects who experienced LDL-C <100 mg/dL

    Time frame: month 12, 24, and 36 follow ups.

Sponsors and collaborators

Lead sponsor

Duke-NUS Graduate Medical School

Other

Collaborators

  • National University Polyclinics, Singapore
  • SingHealth Polyclinics

Registry information

Acronym: SKOPE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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