RESET-CKD for Chronic Kidney Disease

(RESET-CKD Trial)

Overseen By Mary Hannan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Amputation, Orthopedic, Neurologic, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help Black adults with chronic kidney disease (CKD) reduce their daily sitting time. Participants will either receive an intervention called RESET-CKD, which includes tools like health coaching and reminders to reduce sitting time, or they will receive CKD-related education not focused on sitting habits. Black or African American individuals with CKD (Stage 1-4) who sit for over six hours a day might be a good fit for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance daily life for those with CKD.

Do I need to stop my current medications for the RESET-CKD trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on reducing sitting time, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that this intervention is safe for Black adults with chronic kidney disease?

A previous study, the RESET-CKD program, aimed to help Black adults with chronic kidney disease (CKD) sit less and showed promising results. This program includes health coaching and feedback on sitting habits. It does not use medications or involve any medical procedures, eliminating typical drug side effects.

The program emphasizes lifestyle changes, which are generally safe. Participants in similar programs often report feeling more active and healthier. No serious problems have been linked to the program. Overall, the RESET-CKD program is considered safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

RESET-CKD is unique because it focuses on reducing sedentary behavior through a structured, multi-component approach. Unlike traditional treatments for chronic kidney disease, which often involve medication or dietary changes, RESET-CKD combines health coaching, feedback charts, a workbook, and reminders to encourage an active lifestyle. Researchers are excited about this method as it could empower patients to take control of their condition in a way that integrates seamlessly into their daily lives, potentially improving outcomes by addressing the lifestyle factors that contribute to disease progression.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

This trial will compare the RESET-CKD program with an Attention Control group. Studies have shown that reducing sitting time can benefit people with chronic kidney disease (CKD). Research indicates that the RESET-CKD program, which includes health coaching and feedback on sitting habits, helps participants learn to slow CKD progression. In previous studies, patients using similar methods maintained or even improved their kidney health. Additionally, programs like RESET-CKD that focus on behavior change could lead to better health and lower healthcare costs over time. These findings suggest that the RESET-CKD program may effectively help people manage CKD by encouraging them to sit less. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for Black or African American adults aged 40-70 with moderate chronic kidney disease (CKD stages 3 to 4) who sit for more than 6 hours a day. Participants must speak English and have telephone access.

Inclusion Criteria

I can speak, read, and understand English.

I identify as Black or African American.

I sit for 6 or more hours a day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the intervention to reduce sedentary behavior or an attention control condition for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in sedentary time and health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• RESET-CKD

Trial Overview The RESET-CKD intervention aims to help reduce sitting time in participants, while the control group receives CKD-related education not focused on sedentary behavior. The study randomly assigns participants to either group and tracks them for 12 weeks.

How Is the Trial Designed?

Group I: RESET-CKD Experimental Treatment 1 Intervention

RESET-CKD is a 12-week intervention that consists of four major components to support decreasing sedentary behavior: (1) health coaching, (2) feedback charts on sedentary behavior, (3) a workbook, and (4) reminders and cues.

Group II: Attention Control Active Control 1 Intervention

CKD-related education

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., 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]

Patients with chronic kidney disease (CKD) are particularly vulnerable to adverse drug events during hospitalization, which can lead to significant harm.

The study emphasizes the need for new strategies to minimize medical errors and improve safety for CKD patients in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. Fink, JC., Chertow, GM.[2022]

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]

Chronic kidney disease (CKD) is defined as kidney damage or a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m² for three months or more, which is crucial for consistent diagnosis and treatment across different healthcare settings.

The Kidney Disease: Improving Global Outcomes (KDIGO) initiative has established a clear classification system for CKD, which includes five stages based on GFR levels and emphasizes the importance of identifying kidney damage through albuminuria, aiding in better management and research collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Levey, AS., Eckardt, KU., Tsukamoto, Y., et al.[2023]

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]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Citations

1. nursing.uic.edu nursing.uic.edu/research/an-intervention-to-reduce-sedentary-behavior-for-black-adults-with-chronic-kidney-disease-reset-ckd/

An intervention to reduce sedentary behavior for Black adults ... In Aim 3, we will explore the lived experience of the RESET-CKD intervention participants and identify barriers and facilitators to reducing sedentary time.

2. mdpi.com mdpi.com/2077-0383/13/1/66

Virtual Care in Nephrology: An In-Depth Retrospective ... The analyses showed that a majority of patients managed with the Reset Kidney Health Model experienced stability or improvements in their kidney ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10647954/

Effectiveness of Program to Slow Progression of Chronic ... The patients who received the intervention had significantly better knowledge of how to slow the progression of kidney disease (MD = 6.18, SD = ...

4. link.springer.com link.springer.com/article/10.1007/s12325-025-03370-w

The REnal Surrogacy accEpTance in Chronic Kidney ... We present the experience of the REnal Surrogacy accEpTance in CKD (RESET CKD) Collaboration as a case study within nephrology, where patients ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051227621000297

Cost-Effectiveness of Behavior Modification Intervention for ... Behaviour modification intervention for patients with chronic kidney disease could provide a mid- to long-term reduction in public health care expenditure: ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2588106/

Chronic Kidney Disease Adversely Influences Patient Safety Patients with CKD were significantly more likely to die during a hospitalization for a condition considered to be at low mortality risk (IRR 1.53; 95% CI 1.14 ...

7. emedicine.medscape.com emedicine.medscape.com/article/238798-overview

Chronic Kidney Disease (CKD) A term that encompasses all degrees of decreased kidney function, from damaged–at risk through mild, moderate, and severe chronic kidney failure.