A Dual-centre, Two-arm, Open-label Randomized Controlled Trial Comparing an Integrated Collaborative Nurse-led Physician-supported Multimorbid Chronic Kidney Disease Care Model Versus Physician-led Care (INTEGREAT-CKD)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
Wei Zhen Hong
RECRUITING
Singapore
Contact Information
Primary
Wei Zhen Hong, MBBS, MRCP, MMed
wei_zhen_hong@nuhs.edu.sg
97330789
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 220
Treatments
No_intervention: Control group
Control arm: Patients will be assigned to a consultation model of CKD care which consists of clinic reviews by a nephrologist, which is as per current standard of care. The frequency of reviews, which is at the discretion of the nephrologist, is typically scheduled at 4 to 6 monthly intervals. Each consultation lasts an average of 10 to 15 minutes.
Experimental: INTEGREAT-CKD Intervention
Intervention arm: Patients will be assigned to a consultation model of CKD care which consists of 30-minute clinic reviews led by an advanced practice nurse (APN), with both on-site and remote support from a nephrologist, at 3 monthly intervals. Patients will be required to monitor certain clinical parameters (one of or a combination of blood pressure, glucose trend or weight trend) between clinic reviews, tapping on a telehealth platform for transmission of data to an assigned community-based nurse, who will provide oversight of these readings, with regular escalation to the APN/nephrologist. The on-site remote support, in the form of telehealth monitoring, will be concurrent between clinic consults, with frequency of monitoring individualized as per patient's needs.
Related Therapeutic Areas
Sponsors
Leads: Alexandra Hospital
Collaborators: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov