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Chronic Kidney DiseasesSKOPENCT05295368

Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

A study testing Multicomponent intervention in people with Chronic Kidney Diseases, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 79 years
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Multicomponent intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
724 participants
Where
1 siteSingapore
Study dates
21 Jul 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • SingHealth Polyclinics

    Singapore

Other trials in Singapore

About this 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.

Read more

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

Being tested
Multicomponent intervention
Keywords
chronic kidney disease, clinical trial, primary care, kidney function
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent interventionOther

    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.

Study groups in NCT05295368
Study groupRoleWhat they receive
multicomponent interventionExperimental1) 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.
Receives: Other: Multicomponent intervention
Usual careNo interventiontreated by physicians and nurses who are not trained in SKOPE treatment algorithms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the eGFR

    Measured: from randomization to final follow-up at 36 months

Secondary outcomes (7)

  1. 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

    Measured: at 12, 24, and 36 months from the baseline

  2. 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).

    Measured: at 12, 24, and 36 months from the baseline

  3. guideline-directed medical therapy (GDMT) goals

    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

    Measured: at 12, 24, and 36 months from the baseline

  4. 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:

    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

    Measured: at 12, 24, and 36 months from the baseline

  5. MoCA score

    continuous outcome

    Measured: at 36 months from the baseline

  6. Mild cognitive impairment

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

    Measured: at 36 months from the baseline

  7. Handgrip strength

    Measured by dynamometer

    Measured: at 36 months from the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start21 Jul 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
724 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295368
Sponsor's protocol ID
CSASI20nov-0001
Acronym
SKOPE
Status last verified
May 2026
First submitted
15 Mar 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39472975

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent intervention in people with Chronic Kidney Diseases, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the eGFR (time frame: from randomization to final follow-up at 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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