What side effects are associated with this type of intervention?

Educational interventions and health coaching for renal disease generally have minimal side effects, as they focus on improving patient knowledge, self-management, and decision-making. However, common treatments for renal disease, such as erythropoiesis-stimulating agents (ESAs), can cause hypertension, thromboembolic events, and increased risk of cardiovascular issues. Glucocorticoids, often used in high-risk patients, can lead to serious adverse events like infections and hospitalizations, especially at higher doses. Reduced-dose glucocorticoids combined with antibiotic prophylaxis can mitigate some of these risks.

What prior FDA approvals exist?

FDA-approved treatments for renal disease often include medications such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) to manage hypertension and reduce proteinuria, which are critical in slowing CKD progression. Additionally, erythropoiesis-stimulating agents (ESAs) are approved for treating anemia associated with CKD. Lifestyle interventions, including dietary modifications, weight control, and smoking cessation, are also recommended and align with the educational and coaching strategies studied in the Encounter Decision Intervention (EDI) and Health Coaching trials. These comprehensive approaches aim to improve patient outcomes by combining pharmacological treatments with personalized education and support.

What other types of research exist?

Promising novel alternatives for renal disease patients considering treatment in 2024 include virtual multidisciplinary care programs, which aim to improve disease knowledge and increase interest in home dialysis therapies. Peer mentoring programs have also shown effectiveness in supporting patients' decision-making regarding kidney replacement treatments. Additionally, telemedicine and electronic consultation systems (e-Consult) can enhance kidney care delivery by improving access and facilitating better patient-provider communication.

← Back to Search

Education and Coaching for Kidney Disease (CHECK-D Trial)

N/A

Waitlist Available

Led By Julie Wright, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CKD stage 3, 4, or 5 documented in medical record

Has diagnosis of hypertension documented in medical record and most recent Blood Pressure (BP) within the last year meets criteria of uncontrolled hypertension (≥140 mmHg, and/or a diastolic blood pressure ≥90 mmHg noted in an ambulatory care setting within the past one year)

Must not have

Currently on dialysis permanently (i.e. are considered 'end-stage renal disease' and receiving dialysis)

Previous kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special educational worksheet and health coaching to help CKD patients manage their condition better. The study aims to see if this approach improves their blood pressure and overall health. Patients receive personalized information and periodic phone calls with a health coach.

Who is the study for?

This trial is for adults with chronic kidney disease stages 3, 4, or 5 who also have high blood pressure that hasn't been controlled well. They should know about their CKD diagnosis and have a specific level of kidney function. People can't join if they're pregnant, on permanent dialysis, had a kidney transplant, terminally ill or have cognitive issues affecting participation.

What is being tested?

The study tests whether an educational worksheet (EDI) plus health coaching can better manage blood pressure in CKD patients compared to just the EDI alone. The goal is to see if this combination leads to improved health outcomes for those with CKD.

What are the potential side effects?

Since the interventions involve education and coaching rather than medications or medical procedures, there are no direct side effects from treatments like you'd expect with drugs or surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition is chronic kidney disease stage 3, 4, or 5.

Select...

My latest blood pressure reading is 140/90 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am on permanent dialysis for end-stage kidney disease.

Select...

I have had a kidney transplant.

Select...

I am pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Systolic Blood Pressure between baseline and 12 months

Secondary study objectives

CKD knowledge measured by the Kidney Knowledge Survey (KiKS)

Change in Diastolic Blood Pressure between baseline and 12 months

Change in serum creatinine

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Eligible patients enrolled from the intervention group clinics will be given an Intervention-EDI which has personalized information about kidney disease. There will be space on this for the provider to type in any goals or key points they want the patient to remember. Additionally, patients in this group will also receive health coaching.

Group II: ControlActive Control1 Intervention

Eligible patients enrolled from the control group clinics will be given a Control-EDI which has information about kidney disease in general (not tailored to the patient) during their clinic visit.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for renal disease, particularly those involving educational and behavioral interventions like the Encounter Decision Intervention (EDI) and Health Coaching, focus on empowering patients through knowledge and personalized support. These interventions educate patients on the importance of controlling blood pressure, adhering to dietary recommendations, and taking medications as prescribed. Health coaching offers tailored guidance to help patients make and sustain these lifestyle changes. This approach is crucial for renal disease patients as it can improve disease management, enhance quality of life, and potentially slow the progression of chronic kidney disease.

Improving Blood Pressure Management in Primary Care Patients with Chronic Kidney Disease: a Systematic Review of Interventions and Implementation Strategies.Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy.