A Pragmatic Approach to CKD Patient Education

NCT05138419 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-01-07

Study results available
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Summary

Over 350,000 adult Arkansans have chronic kidney disease (CKD) and 9 out of 10 (312,000) of these Arkansans are unaware of having it. A "Know Your Kidney Number" (eGFR) poster (KYKN) campaign is being launched statewide to increase CKD awareness and detection. As awareness increases, the demand for patient education will increase. Educating patients has proven to be effective in delaying CKD progression and establishing optimal renal replacement therapy (RRT) when needed. CKD patient education has historically been provided by nephrology clinicians. Yet most patients are not referred to nephrology until the patient is nearing the need for RRT. Novel pragmatic approaches to reaching and educating patients earlier in their disease state and partnering with a broader pool of clinicians that can provide the education is needed. Most problems related to CKD start when kidney function is \~45 %, earlier education can empower patients to make changes to protect their kidney function earlier and plan for RRT.

University of Arkansas for Medical Sciences (UAMS) developed and copyrighted the "CKD: What You Need to Know" patient education system. Research showed almost 90% of the attendees could choose a modality after either tele-education (TE) or face to face (FTF) education. Home modality choices doubled. Patients were able to make informed choices regardless of the modality of education. Of those starting RRT 47% started on a home modality or received a transplant. This compares to 10% nationally. Both transplant and home dialysis have better outcomes and are less costly compared to in-center hemodialysis.

Harp's Pharmacy has a successful medication therapy management (MTM) program where pharmacists are provided time for patient-centered activities for patients with diabetes (DM), hypertension (HTN), the 2 leading causes for CKD, and heart failure (HF), the leading cause of death in CKD. Thirty six percent of patients with DM will develop CKD and hypertension can be both a cause and an effect of CKD. In this project Harp's Pharmacy will use the MTM infrastructure to add CKD to the program in select pharmacies in the delta. The CKD tools build on and support actions that improve the underlying conditions that are already being addressed. The "CKD: What You Need to Know" tools will be used with patients with known CKD or 2 of the 3 conditions covered by MTM and randomized into 1 of 2 education arms that offer various levels of support or a control arm.

Conditions

  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease stage4
  • Chronic Kidney Disease Stage 5
  • Patient Engagement

Interventions

OTHER

CKD "What You Need To Know" Workbook System

139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material

OTHER

CKD Action Plan

Goals based on international guidelines that can protect kidney function (1 knowledge and 10 action goals) Patient education material used separately for control arm.

OTHER

CKD Web-based Resource List

CKD Patient education material used separately for control arm

OTHER

Food Label reading exercise

CKD Patient education material used separately in all arms.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Manisha Singh, MD · UAMS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-10-23
Completion
2024-10-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138419 on ClinicalTrials.gov