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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months

Awards & highlights

CHECK-D Trial Summary

This trial will test whether an educational intervention can help people with chronic kidney disease improve their health outcomes.

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.Check my eligibility

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.See study design

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.

CHECK-D Trial Eligibility Criteria

Inclusion Criteria

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

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

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

CHECK-D Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Systolic Blood Pressure between baseline and 12 months

Secondary outcome measures

CKD knowledge measured by the Kidney Knowledge Survey (KiKS)

Change in Diastolic Blood Pressure between baseline and 12 months

Change in estimated glomerular filtration rate (eGFR)

+18 more

CHECK-D 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,795 Previous Clinical Trials

6,373,616 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,314,866 Total Patients Enrolled

Julie Wright, MDPrincipal Investigator - University of Michigan

University of Michigan

1 Previous Clinical Trials

2,960 Total Patients Enrolled

Media Library

Renal Disease Clinical Trial 2023: Encounter Decision Intervention (EDI) Highlights & Side Effects. Trial Name: NCT04087798 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adults aged 60 or above partake in this trial?

"As outlined by the trial's guidelines, potential participants must be 21 years old or older and cannot exceed 85 years of age."

Answered by AI

In how many distinct areas is this research trial being conducted?

"At the moment, 11 distinct medical sites are operating this trial. These include Canton, Ann Arbor and Chelsea with 8 additional locales. To reduce travel costs for those taking part in the experiment, it is recommended to choose a site located closest to you."

Answered by AI

What are the prerequisites for enrolment in this clinical trial?

"The recruitment criteria for this medical trial requires participants to have a chronic illness and be aged between 21-85. In total, 350 people can take part in the study."

Answered by AI

Is this medical trial currently enrolling participants?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first launched on February 4th 2020, is actively seeking patient enrolment. All told, 350 patients are needed between 11 different medical sites."

Answered by AI

How many individuals are participating in the research study?

"Indeed, the clinicaltrials.gov website affirms that this study is actively enrolling participants. The trial was first published on February 4th 2020 and its most recent update can be traced back to August 30 2022; 350 patients are set to partake in 11 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Controlling Hypertension Through Education and Coaching in Kidney Disease

Julie Wright-Nunes 2020. "Controlling Hypertension Through Education and Coaching in Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04087798.

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