NCT06372743Recruiting
Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity
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)
Source: ClinicalTrials.gov · Last updated 18 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 30 Oct 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 31 May 2025
- Lead sponsor
- Alexandra Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06372743
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Nov 2023 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- End stage kidney disease
- Dementia and/or cognitive impairment
Other
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wei Zhen Hong Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.