Screening for Chronic Kidney Disease

Overseen By David Collister, MD, PhD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Kidney failure, Chronic kidney disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

3356 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Virtual Kidney Check and Follow-up for chronic kidney disease?

Research shows that virtual clinics and remote monitoring systems for chronic kidney disease (CKD) can effectively track patient health and prevent emergency situations, like the need for urgent dialysis. These systems help manage CKD by providing regular check-ups without face-to-face visits, which can improve patient outcomes and quality of life. ^{1 2 3 4 5}

Is the Virtual Kidney Check and Follow-up treatment safe for humans?

The Virtual Kidney Check and Follow-up treatment, which involves telemedicine and digital applications, has been used to monitor and improve safety in chronic kidney disease (CKD) patients. While CKD patients are at high risk for adverse safety events, these digital tools aim to reduce such risks by allowing remote communication of safety-related findings to healthcare providers. ^{6 7 8 9 10}

How does the Virtual Kidney Check and Follow-up treatment for chronic kidney disease differ from other treatments?

The Virtual Kidney Check and Follow-up treatment is unique because it focuses on early detection and monitoring of chronic kidney disease through virtual means, which may include telehealth consultations and remote monitoring, rather than traditional in-person visits. This approach aims to improve accessibility and convenience for patients, especially those at high risk, by providing timely interventions and follow-up care. ^{8 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are: * To identify chronic kidney disease in First Nations adults in Manitoba * To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category * To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure Participants will be randomized to: 1. Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio 2. Patient and primary care network contact via mail with a letter but no laboratory requisition The primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.

Research Team

David Collister, MD, PhD, FRCPC

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for First Nations adults living in Manitoba who are at least 18 years old. It's designed to help those from any urban, rural, or remote location. The study aims to find the best way to screen and manage chronic kidney disease (CKD) within this population.

Inclusion Criteria

Urban, rural or remote location

Resident of Manitoba

First Nations

Exclusion Criteria

Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years

I am on dialysis or have had a kidney transplant.

I have chronic kidney disease with low kidney function for over 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 months

Virtual and mail-based contact

Treatment

Participants receive treatments to prevent the progression of chronic kidney disease, including mineral corticoid receptor antagonists, SGLT2 inhibitors, and other therapies

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking changes in estimated Glomerular Filtration Rate and other health outcomes

5 years

Treatment Details

Interventions

• Virtual Kidney Check and Follow-up

Trial Overview The trial tests two methods of inviting participants for CKD screening: one group receives a mail letter with lab requests for specific tests, while the other gets just a letter without lab requests. The goal is to see which method leads more people to get screened within six months.

Participant Groups

Group I: Patient contact via mail with a letter and laboratory requisition Experimental Treatment 1 Intervention

Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio

Group II: Patient and primary care network contact via mail with a letter but no laboratory requisition Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Manitoba Health, Seniors and Long-Term Care, Province of Manitoba

Collaborator

Trials

1

Recruited

3,400+

Seven Oaks General Hospital

Collaborator

Trials

2

Recruited

3,400+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

First Nations Health and Social Secretariat of Manitoba

Collaborator

Trials

2

Recruited

5,900+

Shared Health Manitoba

Collaborator

Trials

1

Recruited

3,400+

Research Manitoba

Collaborator

Trials

13

Recruited

17,500+

Findings from Research

A pilot trial involving 52 patients with advanced chronic kidney disease (CKD) tested the feasibility of using online electronic patient-reported outcome measures (ePROMs) for real-time symptom monitoring, showing high retention (96%) and adherence (74% at 180 days).

The ePROM intervention was well-accepted by patients, indicating potential for improving patient engagement in managing CKD, although strategies are needed to maintain long-term participation beyond 270 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. Kyte, D., Anderson, N., Bishop, J., et al.[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]

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]

In a 1-year study involving 182 outpatients with advanced chronic kidney disease (CKD), the eKidneyCare app significantly reduced medication discrepancies compared to the MyMedRec app, indicating better medication management.

eKidneyCare not only lowered the total number of discrepancies but also reduced the severity of clinically relevant discrepancies, including those that could potentially cause serious harm, highlighting its effectiveness in improving medication safety for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Ong, SW., Jassal, SV., Porter, EC., et al.[2023]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

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 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.

The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

The National Kidney Foundation's Kidney Early Evaluation Program (KEEP) effectively identifies chronic kidney disease (CKD) in high-risk populations, with 28.7% of the 100,000 participants screened found to have CKD, compared to a lower prevalence of 13.1% reported in the general population.

KEEP's structured screening approach not only detects CKD early but also enhances understanding of kidney disease, supporting public health initiatives aimed at improving outcomes for individuals with diabetes, hypertension, or a family history of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. Vassalotti, JA., Li, S., Chen, SC., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Telenephrology application in rural and remote areas of Jordan: benefits and impact on quality of life. [2016]

3. England pubmed.ncbi.nlm.nih.gov

A virtual clinic to improve long-term outcomes in chronic kidney disease. [2020]

4. Malaysia pubmed.ncbi.nlm.nih.gov

CKD-CHECK toolkit to improve doctors' practice in managing chronic kidney disease rapid progressors: a pilot study in primary care setting. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Variability and risk factors for kidney disease progression and death following attainment of stage 4 CKD in a referred cohort. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Screening for chronic kidney disease in Australia: a pilot study in the community and workplace. [2022]

9. United States 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. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Participant follow-up in the Kidney Early Evaluation Program (KEEP) after initial detection. [2008]

12. United States pubmed.ncbi.nlm.nih.gov

Risk factors and screening for chronic kidney disease. [2022]

13. Australia pubmed.ncbi.nlm.nih.gov

Challenges of conducting kidney health checks among patients at risk of chronic kidney disease and attending an urban Aboriginal and Torres Strait Islander primary healthcare service. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. [2022]