What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Patient education interventions, such as the CKD: What You Need to Know system, are generally safe and do not have direct physical side effects. However, potential indirect effects may include anxiety or stress as patients become more aware of their condition and the decisions they need to make regarding their treatment. Additionally, there may be a temporary sense of information overload or confusion if the educational material is not well understood. Effective communication and support from healthcare providers can help mitigate these effects.

What prior FDA approvals exist?

The 'CKD: What You Need to Know' patient education system focuses on empowering patients with chronic kidney disease (CKD) to make informed decisions about their management and renal replacement therapy (RRT) options. While there are no specific FDA-approved drugs for patient engagement, educational interventions and pharmacist-led programs have shown significant benefits. These programs improve patient knowledge, adherence to treatment, and clinical outcomes, which are crucial for managing CKD effectively. The involvement of pharmacists in medication therapy management and patient education has been particularly effective in enhancing patient engagement and optimizing treatment plans.

What other types of research exist?

Promising, novel alternatives to the 'CKD: What You Need to Know' patient education system for 2024 include: 1) Enhanced personal health records integrated with electronic health systems to provide stage-specific CKD education and goals of care. 2) Patient navigator programs that offer personalized guidance and support throughout the CKD management journey. 3) Tele-education platforms that allow for remote, interactive learning sessions tailored to individual patient needs. 4) Multidisciplinary education programs that involve pharmacists, dietitians, and other healthcare providers to address the comprehensive needs of CKD patients. 5) Mobile health applications that offer real-time monitoring, educational resources, and reminders to improve patient adherence and engagement.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

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

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.

0 / 2Eligibility 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

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.