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CKD Education Program for Kidney Disease (PACED Trial)

N/A
Recruiting
Led By Manisha Singh, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has Known CKD or 2 of the 3 conditions covered in MTM (DM, HTN and Heart Failure)
Not on dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months

Summary

This trial uses an educational program called 'CKD: What You Need to Know' to help adults in Arkansas with CKD or related conditions. The program provides information that helps patients understand their condition and make informed treatment choices. Early education can delay disease progression and improve treatment outcomes.

Who is the study for?
This trial is for adults over 18 enrolled in Harp's MTM program who have chronic kidney disease (CKD) or two of the following conditions: diabetes, hypertension, and heart failure. They should not be on dialysis and must be able to read/speak English without significant cognitive dysfunction unless they have a caregiver.
What is being tested?
The study tests educational tools like the 'CKD: What You Need To Know' workbook system, action plan, web resources list, and food label reading exercise. It aims to educate patients about CKD management early on to delay disease progression.
What are the potential side effects?
Since this trial focuses on education rather than medication or medical procedures, there are no direct side effects from interventions. However, learning about one's condition can sometimes cause emotional or psychological stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic kidney disease or at least two of these: diabetes, high blood pressure, heart failure.
Select...
I am not undergoing dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Kidney Transplantation
Kidney Transplantation
Number of subjects that choose a form of home dialysis (Home Hemodialysis or peritoneal dialysis) by the end of the study.
+3 more
Secondary study objectives
Amount of time spent by pharmacist and staff per subject
Intra cluster analysis to evaluate effectiveness of each teaching style used by peer educators
Patient Engagement (percent of applicable Action Plan (AP) goals selected)
+2 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Case Management Model (CMM)Active Control4 Interventions
CMM includes 3 visits of pharmacist initiated discussion of workbook content (including AP \[action plan\] and CKD web-based sites) and AP reinforcement. Pre-testing is done on Visit 1 (V1) and Post testing and program evaluation on V3. Subjects are asked to read 1 chapter a week, write down questions and take tests at the end of chapters. On V1 pharmacist introduces the Workbook System highlighting chapters 1-4 and assist with AP goal selection. On V2, the pharmacist answers questions, provides chapter 4-8 highlights and reviews AP goal progress and food label exercise. On V3, pharmacist answers questions, expands on workbook content and reviews AP goals progress and program evaluation including modality and transplant questions from pre/posttests, identification and ranking of peer cluster leader teaching style and effectiveness, identification of AP goals selected and ranking of helpfulness is completed. Pharmacists track time spent at each visit to compare cost and outcomes.
Group II: Self Study (SS)Active Control4 Interventions
SS includes 2 visits. Subjects receive the workbook, paper copies of AP and food label exercise. Pre-testing will be done on V1 and Post testing on V2, eight weeks later. Subjects will be asked to read 1 chapter a week for the next 8 weeks. The pharmacist will provide a brief introduction of the workbook (5-10 minutes) and the AP. Only subject initiated questions will be answered. On V2, the pharmacist will answer subject initiated questions and ask about progress in the AP goal attainment and the program evaluation will be completed, as described in arm 1.Pharmacists track time spent at each visit to compare cost and outcomes.
Group III: Control (Ctrl)Placebo Group3 Interventions
Ctrl includes 2 visits. Subjects receive a list of web-based CKD sites, a food label exercise and a copy of the AP with no additional intervention, other than answering subject initiated questions, on V1. Pre-testing will be done on V1 and Post testing on V2 and program evaluation will be done eight weeks later. On V2, the pharmacist will ask about AP goals and answer subject initiated questions. Pharmacists track time spent at each visit to compare cost and outcomes.

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
The 'CKD: What You Need to Know' patient education system aims to empower patients by providing comprehensive information about chronic kidney disease (CKD) management and renal replacement therapy (RRT) options. The primary mechanism of action involves educating patients through tele-education (TE) or face-to-face (FTF) sessions, which helps them understand their condition, treatment options, and lifestyle changes needed to slow disease progression. This education enables patients to make informed decisions, potentially delaying the need for RRT and improving outcomes. Effective patient engagement through education is crucial as it leads to better disease management, increased home modality choices, and higher rates of transplant or home dialysis, which are associated with better outcomes and lower costs compared to in-center hemodialysis.
Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,422 Total Patients Enrolled
Manisha Singh, MDPrincipal InvestigatorUAMS

Media Library

Case Management Model (CMM) Clinical Trial Eligibility Overview. Trial Name: NCT05138419 — N/A
Patient Engagement Research Study Groups: Case Management Model (CMM), Control (Ctrl), Self Study (SS)
Patient Engagement Clinical Trial 2023: Case Management Model (CMM) Highlights & Side Effects. Trial Name: NCT05138419 — N/A
Case Management Model (CMM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05138419 — N/A
~47 spots leftby Oct 2025