Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity

NCT06372743 | Recruiting DMC

• 1 other identifier: Alex Hospital
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks from participants' date of enrollment

Secondary Outcomes (1)

• Secondary outcome

  24 weeks from participants' date of enrollment

Study Arms (2)

Control group

NO INTERVENTION

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.

INTEGREAT-CKD Intervention

EXPERIMENTAL

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.

Other: INTEGREAT-CKD Intervention

Interventions

INTEGREAT-CKD Intervention OTHER

The 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.

INTEGREAT-CKD Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Hospital: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

Wei Zhen Hong

Singapore, 119228, Singapore

RECRUITING

Related Publications (2)

• Stanifer JW, Von Isenburg M, Chertow GM, Anand S. Chronic kidney disease care models in low- and middle-income countries: a systematic review. BMJ Glob Health. 2018 Apr 1;3(2):e000728. doi: 10.1136/bmjgh-2018-000728. eCollection 2018.

  PMID: 29629191 RESULT

• Davis KM, Eckert MC, Hutchinson A, Harmon J, Sharplin G, Shakib S, Caughey GE. Effectiveness of nurse-led services for people with chronic disease in achieving an outcome of continuity of care at the primary-secondary healthcare interface: A quantitative systematic review. Int J Nurs Stud. 2021 Sep;121:103986. doi: 10.1016/j.ijnurstu.2021.103986. Epub 2021 May 27.

  PMID: 34242979 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Zhen Hong, MBBS, MRCP, MMed

CONTACT

97330789; wei_zhen_hong@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a dual-centre two-arm, open-label randomized controlled trial (RCT). Patients are randomized with a one-to-one allocation into two parallel groups.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: April 18, 2024
• Study Start: November 1, 2023
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)