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

Trial Summary

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 data supports the effectiveness of the treatment RESET-CKD for Chronic Kidney Disease?

The research indicates that kidney function can improve in some patients with hypertensive chronic kidney disease (CKD) when they have low levels of protein in their urine and maintain a lower blood pressure goal. This suggests that certain management strategies can lead to improvements in kidney function, which may be relevant to the effectiveness of the RESET-CKD treatment. ^{1 2 3 4 5}

Is the RESET-CKD treatment safe for humans?

The research highlights that patients with chronic kidney disease (CKD) are at high risk for safety issues, especially related to medication errors and adverse drug events. While these studies focus on CKD in general, they emphasize the importance of careful management to prevent safety problems, suggesting that any treatment, including RESET-CKD, should be closely monitored for safety in this population. ^{6 7 8 9 10}

What is the purpose of this trial?

RESET-CKD is evaluating an intervention to support Black adults with chronic kidney disease (CKD) to reduce their sedentary (e.g., sitting) time. Half of the participants will be randomized to the intervention, where the goal is to support individuals to reduce their sitting time, and the other half will be randomized to an attention control condition that provides CKD-related education not related to sedentary behavior. All participants will be followed for 12 weeks.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

References

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

Serum Anion Gap Predicts All-Cause Mortality in Patients with Advanced Chronic Kidney Disease: A Retrospective Analysis of a Randomized Controlled Study. [2019]

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

Kidney function can improve in patients with hypertensive CKD. [2022]

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

Chronic kidney disease: towards a risk-based approach. [2020]

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

Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). [2023]

5. 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]

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

CKD as an underrecognized threat to patient safety. [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

Finding a common language for patient safety in CKD. [2019]

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

Medication errors in chronic kidney disease: one piece in the patient safety puzzle. [2022]

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

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