About this trial
Chronic kidney disease (CKD) is a prevalent chronic disease and is often intertwined with the management of cardiovascular disease and the optimization of metabolic risk factors. In light of steeply rising rates of end-stage kidney disease (ESKD) and increased healthcare resource utilization by CKD patients, the investigators propose that the role of nurses could be expanded to support the care of CKD patients in the community.
A total of 220 patients will be randomized (1:1) to the intervention or control groups (usual care). The intervention entails enrolment into a nurse-led, physician-supported programme (INTEGREAT-CKD), comprising outpatient consultations and community-based ambulatory monitoring and counselling primarily driven by CKD-trained advanced practice nurses (APNs) and healthcare professionals conducted over 6 months. Patient-reported outcomes like health-related quality of life (HRQOL), as measured by EQ-5D and KDQOL, CKD self-management score and CKD health literacy will be assessed at baseline and after 6 months. The primary outcome is CKD self-management. Other secondary outcomes to be assessed and tracked including achievement of clinical targets relevant to slowing down CKD progression, attainment of CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines 2020.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 21 years and above AND diagnosed with
CKD Stages 3B and above (defined as estimated GFR less than or equal to 44 mL/min/1.73m2 with evidence of kidney damage) AND diagnosed with
one or more of the following sub-optimally managed parameters pertaining to blood pressure control OR, glycemic control OR fluid status management.
Disqualifiers
Pregnancy
End stage kidney disease
Enrolment in any structured outpatient-based or community-based CKD program for at least six months prior to or during the period of enrolment in the study.
Dementia and/or cognitive impairment
Trial design
Parallel
Treatments tested in this trial
INTEGREAT-CKD Intervention
Other interventionThe participant is reviewed once in 12 weeks by a CKD-trained APN, during a 30-minute timeslot, an extended duration compared to the timeslot of 10 to 15 minutes that routinely is designated for a recurrent review of a CKD patient in any restructured hospital in Singapore. The review consists of a 15-minute medical review centred on a discussion of the biochemical reports and clinical data relevant to CKD management, and educating on CKD knowledge and lifestyle modification. Patients self-report the monitored parameters to a community-based nurse through a telehealth AI-based platform. The APN oversees monitoring the community-based parameters and titration of appropriate medications. The APNs have received a Master's in Nursing, with training that is primarily centred on generalist-led care, with additional clinical training in CKD management. They are supported with protocols to detect anomalies in blood pressure trends, glycemia ranges, and abnormalities in fluid status.
Treatment groups
Trial outcomes
Primary outcomes
Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire
Patients will be scored based on their questionnaire responses and the primary outcome is the improvement in the CKD-SM score. Baseline scoring is done during enrolment.
Secondary outcomes
Secondary outcome
(a) An achievement of clinical targets relevant to slowing down CKD progression: a. Individualised blood pressure target achieved depending on clinical profile: i. CKD, non-diabetic with proteinuria: \< 140/80mmHg ii. CKD, diabetic with proteinuria: \< 130/80 b. Target glycemia control: HbA1c lower than 8% c. Achievement and maintenance of euvolemia (individualized target weight that reflects euvolemia) (b) CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines a. Achievement of target biochemical indices related to optimization of CKD care: i. Mineral bone disease (CKD-MBD) 1. Serum phosphate and serum calcium within normal ranges 2. Serum parathyroid hormone to be maintained at approximately 2-9 times the upper normal limit for the assay{, #282} ii. Anemia 1\. Serum haemoglobin 10.5-11.5 g/dL (c) An improvement in the 30-day readmission (d) A reduction in the incidence of emergency department visits
Sponsors and contacts
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Alexandra Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator