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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
Awards & highlights

PACED Trial Summary

This trial will test whether or not providing CKD education to patients earlier on, when they may still be unaware of their condition, can empower them to make changes to protect their kidney function.

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.Check my eligibility
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.See study design
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.

PACED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic kidney disease or at least two of these: diabetes, high blood pressure, heart failure.
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I am not undergoing dialysis.
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I am over 18 years old.

PACED Trial 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

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

PACED 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.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
485 Previous Clinical Trials
149,748 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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~29 spots leftby Aug 2024