Virtual Care for Acute Kidney Injury

(UPTAKE-VC Trial)

Recruiting at 1 trial location

Overseen By Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Non-Alberta residents, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 45 days

354 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for caring for individuals who have experienced acute kidney injury (AKI) and are at high risk of hospital readmission. Participants will either receive virtual care at home, which includes digital health tools and support from healthcare professionals, or continue with their usual care after discharge. The trial aims to determine if virtual care (also known as telemedicine or remote monitoring) can reduce hospital time, prevent readmissions, and improve long-term health outcomes. Individuals hospitalized for more than 48 hours with AKI and at high risk of readmission might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative care methods that could enhance recovery and reduce hospital visits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this method is safe for patients with acute kidney injury?

Research shows that virtual care, including the digital health tools used in this trial, is generally easy for people to use. Studies have found that remote patient monitoring can enhance care for those recovering from acute kidney injury (AKI), aiming to smooth the transition from hospital to home.

Although specific numbers on side effects are unavailable, digital health tools have supported recovery and shortened hospital stays. No strong evidence indicates major safety concerns, and these tools have effectively managed AKI. These methods aim to make recovery safer and more efficient without adding extra risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual care for acute kidney injury because it offers a more personalized and convenient approach to managing health after a hospital stay. Unlike the usual care where patients go home without additional support, virtual care uses technology to create a seamless transition from hospital to home by connecting patients with healthcare providers remotely. This method not only aims to reduce readmission rates by providing continuous monitoring and support but also empowers patients to manage their health more effectively from the comfort of their home.

What evidence suggests that this virtual care method is effective for acute kidney injury?

This trial will compare Virtual Care with Usual Care for patients with acute kidney injury (AKI). Research has shown that virtual care, provided to participants in the Virtual Care arm, can enhance recovery for AKI patients. Studies have found that remote monitoring can improve the quality and speed of care for those who have experienced AKI. Programs enabling patients to receive hospital-level care at home through remote monitoring can shorten hospital stays and reduce readmission rates. Digital health tools can also predict and manage risks related to AKI, potentially preventing kidney failure and other complications. Video-based telemedicine is increasingly common in kidney care, facilitating easier access for patients. This suggests that digital health solutions might effectively improve long-term outcomes for AKI patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Matthew James, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for hospitalized adults with Acute Kidney Injury (AKI) who are at high risk of being readmitted to the hospital or dying. The study aims to help these individuals by using virtual care strategies.

Inclusion Criteria

My LACE score is 12 or higher.

AKI identified in hospital using Kidney Disease Improving Global Outcomes (KDIGO) criteria

Meets all inclusion criteria of Virtual Home Hospital programs of Calgary and Edmonton zones

Exclusion Criteria

Hospitalization > 30 days

Non-Alberta residents

Resides outside the catchment areas for the Calgary and Edmonton Virtual Home Hospital programs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vanguard Phase

Initial implementation to establish feasibility and acceptability of the intervention

Varies

Treatment

Participants receive virtual care through Virtual Home Hospital programs, including digital remote patient monitoring and regular virtual assessments

Up to 45 days

Regular virtual assessments via telephone or videoconferencing

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of kidney function and complications of AKI

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Care

Trial Overview The UPTAKE trial is testing a virtual home hospital system with remote monitoring against usual care for AKI patients. It's a randomized controlled trial, meaning people are put into groups by chance, and it will last three years.

How Is the Trial Designed?

Group I: Virtual Care Experimental Treatment 1 Intervention

Participants will receive virtual care through Virtual Home Hospital programs in Alberta for their hospital to home transition of care.

Group II: Usual Care Active Control 1 Intervention

Participants will be discharged as per usual care practices from hospital to their home.

Virtual Care is already approved in Canada for the following indications:

Approved in Canada as Virtual Care for:

• Acute Kidney Injury (AKI)
• Reducing hospital readmission rates
• Improving long-term outcomes

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

A survey of 372 patients with chronic kidney disease revealed that 68% found telephone consultations comfortable and 73% considered them safer during the COVID-19 pandemic, highlighting a positive reception to this virtual care method.

Despite the advantages, participants noted drawbacks such as the inability to conduct physical examinations and reduced rapport with their nephrologists, indicating that while telephone consultations are effective, in-person visits may still be necessary for certain situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quantitative and Qualitative Study on Patient and Physician Perceptions of Nephrology Telephone Consultation During COVID-19. Heyck Lee, S., Ramondino, S., Gallo, K., et al.[2022]

Remote patient management (RPM) for automated peritoneal dialysis (APD) significantly improves clinical outcomes by enabling timely interventions and reducing the need for in-person hospital visits, as confirmed by a 2-year study of prevalent patients.

The use of a cloud-based software for RPM-APD has led to a notable decrease in patient drop-out rates, hospital visits, and healthcare costs, demonstrating a strong cost-benefit advantage over traditional hospital visit regimes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Management in Peritoneal Dialysis Improves Clinical Outcomes. Milan Manani, S., Crepaldi, C., Giuliani, A., et al.[2021]

Participation in the Cricket Health program significantly improved CKD knowledge among patients, with scores increasing from an average of 52% to 94% correct answers on a knowledge-based survey.

Patients in the program were more likely to start dialysis in an outpatient setting (80% of those who started dialysis) compared to controls (22%), suggesting the program may facilitate better planning for dialysis initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Multidisciplinary Care Program for Management of Advanced Chronic Kidney Disease: Matched Cohort Study. Kaiser, P., Pipitone, O., Franklin, A., et al.[2020]

In a usability study with 12 participants who had chronic kidney disease (CKD) or were family members, 22% of tasks resulted in critical errors, indicating challenges in navigating the Safe Kidney Care website effectively.

Despite some difficulties, participants expressed general satisfaction with the website's content, highlighting the need for web-based educational materials to accommodate varying levels of computer literacy among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of a CKD educational website targeted to patients and their family members. Diamantidis, CJ., Zuckerman, M., Fink, W., et al.[2021]

In a study involving 905 adults discharged after non-elective surgery, virtual care with remote automated monitoring (RAM) did not significantly increase the number of days alive at home compared to standard care, with an average of 29.7 days versus 29.5 days.

However, the virtual care group had a lower rate of acute hospital care (22.0% vs. 27.3%) and reported less pain at 7, 15, and 30 days post-discharge, indicating potential benefits in managing recovery and reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. McGillion, MH., Parlow, J., Borges, FK., et al.[2021]

The virtual CKD clinic (VC) effectively monitored patients with chronic kidney disease (CKD) without any patients requiring emergency dialysis, indicating strong surveillance and management of the condition.

Survival rates for patients monitored through the VC were comparable to those of CKD patients who were discharged to primary care, suggesting that the VC is a viable alternative for managing CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual clinic to improve long-term outcomes in chronic kidney disease. Harnett, P., Jones, M., Almond, M., et al.[2020]

A new telemedicine program for chronic kidney disease (CKD) patients was developed during the COVID-19 pandemic, resulting in 97.4% of participants finding it helpful for managing their health and psychological needs.

The program enabled rapid triage for 17% of patients, leading to timely referrals for worsening medical or psychological conditions, demonstrating its efficacy in providing essential care during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging "Office-Based Care" With the "Virtual Practice Care Model": Evolving Care for Chronic Kidney Disease Patients in the COVID-19 Pandemic-And Beyond. Zhao, B., Zhang, L., Ji, P., et al.[2020]

A remote patient monitoring scheme using digital pens has been successfully implemented since 2006 to monitor patients with chronic kidney disease in their homes, enhancing patient care and convenience.

The program has evolved to include therapeutic patient education, indicating a comprehensive approach to managing chronic kidney disease and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of telemedicine in dialysis and new professional practices]. Grangier, JP.[2017]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

In a study of 64 patients using live interactive telenephrology, 31.2% had their treatment plans changed compared to what their referring health provider suggested, indicating effective diagnosis and management of kidney diseases.

Patients reported significant improvements in their quality of life, with SF8 scores increasing from 33.1 to 45.0 after 2 months, alongside high satisfaction rates due to reduced waiting times and costs associated with teleconsultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telenephrology application in rural and remote areas of Jordan: benefits and impact on quality of life. AlAzab, R., Khader, Y.[2016]

In a study involving 2413 hospitalized patients with acute kidney injury, the implementation of an automated electronic alert system did not lead to improved clinical outcomes, such as changes in creatinine levels, dialysis rates, or mortality, compared to usual care.

The results showed no significant differences in the severity of kidney injury or patient outcomes at 7 days, indicating that the alert system may not be effective in enhancing the management of acute kidney injury in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Wilson, FP., Shashaty, M., Testani, J., et al.[2023]

Telemedicine enabled effective management of a severely ill patient with sepsis and multi-organ failure, allowing for direct review and collaborative support without the need for risky long-distance transfer.

This approach maintained high healthcare standards and kept the patient close to their home and family, highlighting the potential of telemedicine in critical care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The tyranny of distance: telemedicine for the critically ill in rural Australia. Boots, RJ., Singh, SJ., Lipman, J.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11738026/

Acute Kidney Injury Survivor Remote Patient Monitoring Remote patient monitoring (RPM) could improve the quality and efficiency of acute kidney injury (AKI) survivor care.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06537453/uptake-virtual-care-virtual-home-hospital-with-remote-monitoring-to-reduce-acute-care-hospitalization

Virtual Home Hospital With Remote Monitoring to Reduce ... ... hospital stay, readmission rates, and improve long-term outcomes after Acute Kidney Injury (AKI). Number of Participants: Three Hundred and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05806645

Using Personalized Risk and Digital Tools to Guide ... Acute kidney injury (AKI) is common in hospitalized patients and associated with poor long-term outcomes including kidney failure, cardiovascular (CV) events, ...

4. nature.com nature.com/articles/s41581-023-00744-7

Digital health and acute kidney injury: consensus report of ... The use of digital health for risk prediction, prevention, identification and management of AKI and its consequences was discussed.

5. journals.lww.com journals.lww.com/cjasn/fulltext/2021/12000/video_based_telemedicine_for_kidney_disease_care_.10.aspx

Video-Based Telemedicine for Kidney Disease Care Video-based telemedicine is being used for kidney care and has evolved to be less reliant on specialized telemedicine equipment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10422882/

Development and Implementation of an Acute Kidney ... Remote patient monitoring can offer a unique opportunity to bridge the care transition from hospital to home and increase access to quality care ...