Chronic Kidney Disease stage3PACEDNCT05138419
A Pragmatic Approach to CKD Patient Education
A study testing CKD "What You Need To Know" Workbook System, CKD Action Plan and CKD Web-based Resource List in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
- What is being tested?
- CKD "What You Need To Know" Workbook System, CKD Action Plan and CKD Web-based Resource List
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (any gender)>18 years old
- Enrolled in Harp's MTM program
- Has Known CKD or 2 of the 3 conditions covered in MTM (DM, HTN and Heart Failure)
- Not on dialysis
Who cannot join
- unable to read or speak English
- history of significant cognitive dysfunction unless qualified caregiver is the one being educated
- not personally independent or without any social support
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Pragmatic Approach to Chronic Kidney Disease Patient Education in the Delta
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.
Read the detailed description
Using non-nephrology clinicians to expand access to CKD education earlier in the patient's disease progress is essential. This project will inform how various levels of support provided by pharmacists and staff using nephrology developed tools in self-study models can 1) effect patient's ability to select the End Stage Renal Disease (ESRD) modality (Incenter hemodialysis, home hemodialysis, peritoneal dialysis, no dialysis or do not have enough information to make a choice) to use if or when dialysis is needed 2) identify patient's interest in obtaining a renal transplant and, if so, has a possible donor been identified 3) identify actions they are willing to take to protect their current kidney function using a CKD Action Plan that contains 1 knowledge goal and 10 performance goals based on international guidelines 4) allow comparisons of support time and outcomes for each of the 3 groups. Empowering patients to be proactive partners in their health care, through education and accountability, by choosing both the RRT and performance goals to protect the patient's kidneys is key to improving outcomes. Demonstrating that non-nephrology clinicians can effectively educate and support these patients will provide models that other clinicians can use.
Minorities, especially in rural areas, are less likely to receive most kinds of care including evidence-based practices, home dialysis or transplantation. Developing patient-centered approaches to care such as this project can reduce disparities.
One-on-one outreach to educate, motivate and seek the patient's feedback can strengthen commitment and adherence to medical regimens. Learning what to expect can promote self-management behaviors.
The Arkansas Department of Health (ADH) Southeast (SE) region covers most of the Delta and was selected because the SE region had the poorest outcomes for patients starting RRT. In 2017, new patients were predominately black (61%), less than half had seen a nephrologist prior to starting RRT, only 1.3% had seen a dietitian, most (92.3%) started hemodialysis using a catheter and 2.1% started on home peritoneal dialysis. Only 2.1% had no insurance. This data can be tracked annually to track impact.
The tools being used were developed by a multidisciplinary team of nephrology experts which are limited in the delta. Courses including train the trainer classes for pharmacies and 10 points of Care for CKD for clinicians will be conducted. Collaboration with local providers can both educate and promote community engagement.
Harp pharmacists expressed randomization concerns. Harp's Pharmacy reported that many of the MTM subjects have multiple family members or friends enrolled in the study. This could confound randomization into various arms since these subjects are highly likely to compare and contrast the details of the patient's intervention. The research team decided that a cluster randomization schedule would be utilized with each cluster self-selecting a leader that would be enrolled in the study and be responsible for the education of the other cluster members. All cluster members will undergo the same testing.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Patient Engagement
- Being tested
- CKD "What You Need To Know" Workbook System, CKD Action Plan, CKD Web-based Resource List, Food Label reading exercise
- Keywords
- Patient Education, Patient Engagement, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD "What You Need To Know" Workbook SystemOther
139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material
CKD Action PlanOther
Goals based on international guidelines that can protect kidney function (1 knowledge and 10 action goals) Patient education material used separately for control arm.
CKD Web-based Resource ListOther
CKD Patient education material used separately for control arm
Food Label reading exerciseOther
CKD Patient education material used separately in all arms.
| Study group | Role | What they receive |
|---|---|---|
| Case Management Model (CMM) | Active comparator | 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. Receives: Other: CKD "What You Need To Know" Workbook System; Other: CKD Action Plan; Other: CKD Web-based Resource List; Other: Food Label reading exercise |
| Self Study (SS) | Active comparator | 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. Receives: Other: CKD "What You Need To Know" Workbook System; Other: CKD Action Plan; Other: CKD Web-based Resource List; Other: Food Label reading exercise |
| Control (Ctrl) | Sham comparator | 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. Receives: Other: CKD Action Plan; Other: CKD Web-based Resource List; Other: Food Label reading exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study.
This primary study aim is to increase the subject's ability to select a dialysis modality. Descriptive statistics will be used to examine the trend in the subjects' ability to choose or not choose a dialysis modality. Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD), No Dialysis, don't have enough information to make a to make a decision.
Measured: up to 4 months
Number of Subjects That Choose a Form of Home Dialysis (Home Hemodialysis or Peritoneal Dialysis) by the End of the Study.
This aim is to identify the impact interventions have on the subject's choice of modality (home dialysis versus in-center hemodialysis). Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD).
Measured: up to 4 months
Number of Subjects Interested in Kidney Transplant (Pre-test)
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on pre-test, post-test and evaluation form answers.
Measured: before implementation of the intervention, average of 1 week
Number of Subjects Interested in Kidney Transplant (Post-test)
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on post-test evaluation form answers.
Measured: after the intervention, up to 4 months
Number of Subjects With a Possible Donor Identified (Pre-test)
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on pre-test evaluation form answers.
Measured: before implementation of the intervention, average of 1 week
Number of Subjects With a Possible Donor Identified (Post-test)
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on post-test evaluation form answers.
Measured: after the intervention, up to 4 months
Secondary outcomes (5)
Intra Cluster Analysis to Evaluate Effectiveness of Each Teaching Style Used by Peer Educators
Clusters of more than 1 subject will undergo intra cluster analysis per each arm using data from the evaluation form to determine effectiveness of each teaching style used. Examples: Comparisons of self study versus cluster group participation of Workbook content and Handouts materials (Workbook, Chapter Post Tests, Chapter Frequently Asked Questions, Web-sites accessed, Food label exercise outcomes. Number of cluster meetings, Were modality choices discussed, How helpful was their experience (1-5 scale). Open comment section for subjects to expand on their experience, what was especially helpful and what could be improved.
Measured: Up to 4 months
Patient Engagement (Percent of Applicable Action Plan (AP) Goals Selected)
Patient Engagement will be measured by the percent of applicable AP goals selected
The AP has 10 performance goals that are specific, actionable and realistic addressing these areas 1) Diabetes: Goal Hemoglobin A1C (A1C) 2) B/P Goal 3) Exercise Goal 4) Medications to Avoid, ensure taken, system to reorder 5) Stop Smoking 6-7) Kidney Friendly Diet: salt/water/edema, phosphorus/ protein 8) Monitor System for glucose checks, home blood pressure, weight, diet diary 9) Weight Management 10) Anemia: Goal hemoglobin.
When AP is initiated goals already met or are don't apply to subject will be identified. Subject can then select goals to start.
Measured: up to 4 months
Patient Engagement (Percent of Visits Where a Patient-initiated CKD Discussion Takes Place)
Patient Engagement will be measured by the percent of visits where a patient-initiated CKD discussion occurred
Measured: up to 4 months
Patient Engagement (Percent of Goals Met)
Patient Engagement will be measured by the percent of goals met (self-reported or provider-confirmed). Goal completion will be determined from evaluation form, AP form, or study flow sheet.
Measured: up to 4 months
Amount of Time Spent by Pharmacist and Staff Per Subject
Pharmacist and staff will note the time spent on CKD-related issues at each visit on the study flow sheet.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start13 Feb 2023
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Why it stopped: IRB CR Expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized control pilot study using non-nephrology clinicians to educate patients at high risk for CKD how to protect the kidneys and be ready for RRT if needed utilizing nephrology developed educational tools. Pharmacists screen subjects in the MTM program or with the same medical conditions, enroll them in familial or peer clusters of 1 or more subjects and randomized into 1 of the 3 study arms using a site specific randomization schedule. In clusters of more than 1 subject, the group chooses a leader who receives the assigned intervention and shares it other cluster members. All subjects will receive pre and post testing, health literacy evaluation and completes a program evaluation. The 3 arms include 2 education arms and a control arm with various levels of intervention. The two education arms use the CKD: What You Need to Know Workbook including the CKD AP as self-study tools. The control arm receives the CKD AP and a list of CKD Web-based Resources.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manisha Singh, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138419
- Sponsor's protocol ID
- 262853
- Acronym
- PACED
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2021
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Easom AM, Shukla AM, Rotaru D, Ounpraseuth S, Shah SV, Arthur JM, Singh M. Home run-results of a chronic kidney disease Telemedicine Patient Education Study. Clin Kidney J. 2019 Aug 22;13(5):867-872. doi: 10.1093/ckj/sfz096. eCollection 2020 Oct.
PubMed 33123362Shukla AM, Easom A, Singh M, Pandey R, Rotaru D, Wen X, Shah SV. Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. Perit Dial Int. 2017 Sep-Oct;37(5):542-547. doi: 10.3747/pdi.2016.00270. Epub 2017 May 25.
PubMed 28546368Neil N, Guest S, Wong L, Inglese G, Bhattacharyya SK, Gehr T, Walker DR, Golper T. The financial implications for Medicare of greater use of peritoneal dialysis. Clin Ther. 2009 Apr;31(4):880-8. doi: 10.1016/j.clinthera.2009.04.004.
PubMed 19446160Waterman AD, Browne T, Waterman BM, Gladstone EH, Hostetter T. Attitudes and behaviors of African Americans regarding early detection of kidney disease. Am J Kidney Dis. 2008 Apr;51(4):554-62. doi: 10.1053/j.ajkd.2007.12.020. Epub 2008 Mar 6.
PubMed 18371531Szczech LA, Stewart RC, Su HL, DeLoskey RJ, Astor BC, Fox CH, McCullough PA, Vassalotti JA. Primary care detection of chronic kidney disease in adults with type-2 diabetes: the ADD-CKD Study (awareness, detection and drug therapy in type 2 diabetes and chronic kidney disease). PLoS One. 2014 Nov 26;9(11):e110535. doi: 10.1371/journal.pone.0110535. eCollection 2014.
PubMed 25427285Weis L, Metzger M, Haymann JP, Thervet E, Flamant M, Vrtovsnik F, Gauci C, Houillier P, Froissart M, Letavernier E, Stengel B, Boffa JJ; NephroTest Study Group. Renal function can improve at any stage of chronic kidney disease. PLoS One. 2013 Dec 13;8(12):e81835. doi: 10.1371/journal.pone.0081835. eCollection 2013.
PubMed 24349134
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Approach to Chronic Kidney Disease Patient Education in the Delta
- ClinicalTrials.gov ID
- NCT05138419
- Acronym / sponsor ID
- PACED / 262853
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Patient Engagement
- Keywords
- Patient Education, Patient Engagement, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB CR Expired
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Using non-nephrology clinicians to expand access to CKD education earlier in the patient's disease progress is essential. This project will inform how various levels of support provided by pharmacists and staff using nephrology developed tools in self-study models can 1) effect patient's ability to select the End Stage Renal Disease (ESRD) modality (Incenter hemodialysis, home hemodialysis, peritoneal dialysis, no dialysis or do not have enough information to make a choice) to use if or when dialysis is needed 2) identify patient's interest in obtaining a renal transplant and, if so, has a possible donor been identified 3) identify actions they are willing to take to protect their current kidney function using a CKD Action Plan that contains 1 knowledge goal and 10 performance goals based on international guidelines 4) allow comparisons of support time and outcomes for each of the 3 groups. Empowering patients to be proactive partners in their health care, through education and accountability, by choosing both the RRT and performance goals to protect the patient's kidneys is key to improving outcomes. Demonstrating that non-nephrology clinicians can effectively educate and support these patients will provide models that other clinicians can use.
Minorities, especially in rural areas, are less likely to receive most kinds of care including evidence-based practices, home dialysis or transplantation. Developing patient-centered approaches to care such as this project can reduce disparities.
One-on-one outreach to educate, motivate and seek the patient's feedback can strengthen commitment and adherence to medical regimens. Learning what to expect can promote self-management behaviors.
The Arkansas Department of Health (ADH) Southeast (SE) region covers most of the Delta and was selected because the SE region had the poorest outcomes for patients starting RRT. In 2017, new patients were predominately black (61%), less than half had seen a nephrologist prior to starting RRT, only 1.3% had seen a dietitian, most (92.3%) started hemodialysis using a catheter and 2.1% started on home peritoneal dialysis. Only 2.1% had no insurance. This data can be tracked annually to track impact.
The tools being used were developed by a multidisciplinary team of nephrology experts which are limited in the delta. Courses including train the trainer classes for pharmacies and 10 points of Care for CKD for clinicians will be conducted. Collaboration with local providers can both educate and promote community engagement.
Harp pharmacists expressed randomization concerns. Harp's Pharmacy reported that many of the MTM subjects have multiple family members or friends enrolled in the study. This could confound randomization into various arms since these subjects are highly likely to compare and contrast the details of the patient's intervention. The research team decided that a cluster randomization schedule would be utilized with each cluster self-selecting a leader that would be enrolled in the study and be responsible for the education of the other cluster members. All cluster members will undergo the same testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized control pilot study using non-nephrology clinicians to educate patients at high risk for CKD how to protect the kidneys and be ready for RRT if needed utilizing nephrology developed educational tools. Pharmacists screen subjects in the MTM program or with the same medical conditions, enroll them in familial or peer clusters of 1 or more subjects and randomized into 1 of the 3 study arms using a site specific randomization schedule. In clusters of more than 1 subject, the group chooses a leader who receives the assigned intervention and shares it other cluster members. All subjects will receive pre and post testing, health literacy evaluation and completes a program evaluation. The 3 arms include 2 education arms and a control arm with various levels of intervention. The two education arms use the CKD: What You Need to Know Workbook including the CKD AP as self-study tools. The control arm receives the CKD AP and a list of CKD Web-based Resources.
| Arm | Type | Receives |
|---|---|---|
| Case Management Model (CMM) | Active comparator | Other: CKD "What You Need To Know" Workbook System, Other: CKD Action Plan, Other: CKD Web-based Resource List, Other: Food Label reading exerciseCMM 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. |
| Self Study (SS) | Active comparator | Other: CKD "What You Need To Know" Workbook System, Other: CKD Action Plan, Other: CKD Web-based Resource List, Other: Food Label reading exerciseSS 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. |
| Control (Ctrl) | Sham comparator | Other: CKD Action Plan, Other: CKD Web-based Resource List, Other: Food Label reading exerciseCtrl 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. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (any gender)>18 years old
- Enrolled in Harp's MTM program
- Has Known CKD or 2 of the 3 conditions covered in MTM (DM, HTN and Heart Failure)
- Not on dialysis
Key exclusion criteria (3 listed)
- unable to read or speak English
- history of significant cognitive dysfunction unless qualified caregiver is the one being educated
- not personally independent or without any social support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD "What You Need To Know" Workbook System139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material | Other | Case Management Model (CMM), Self Study (SS) |
| CKD Action PlanGoals based on international guidelines that can protect kidney function (1 knowledge and 10 action goals) Patient education material used separately for control arm. | Other | Case Management Model (CMM), Control (Ctrl), Self Study (SS) |
| CKD Web-based Resource ListCKD Patient education material used separately for control arm | Other | Case Management Model (CMM), Control (Ctrl), Self Study (SS) |
| Food Label reading exerciseCKD Patient education material used separately in all arms. | Other | Case Management Model (CMM), Control (Ctrl), Self Study (SS) |
Primary outcome
Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study.
Time frame: up to 4 months
This primary study aim is to increase the subject's ability to select a dialysis modality. Descriptive statistics will be used to examine the trend in the subjects' ability to choose or not choose a dialysis modality. Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD), No Dialysis, don't have enough information to make a to make a decision.
Number of Subjects That Choose a Form of Home Dialysis (Home Hemodialysis or Peritoneal Dialysis) by the End of the Study.
Time frame: up to 4 months
This aim is to identify the impact interventions have on the subject's choice of modality (home dialysis versus in-center hemodialysis). Descriptive statistics will be used to examine the trend of patients answers based on comparisons of responses on pre and post tests and evaluation form with the options of Incenter Hemodialysis (ICH), Home Hemodialysis (HH), Peritoneal Dialysis (PD).
Number of Subjects Interested in Kidney Transplant (Pre-test)
Time frame: before implementation of the intervention, average of 1 week
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on pre-test, post-test and evaluation form answers.
Number of Subjects Interested in Kidney Transplant (Post-test)
Time frame: after the intervention, up to 4 months
Descriptive statistics will be used to examine the trend in the subjects' level of interest in kidney transplant based on post-test evaluation form answers.
Number of Subjects With a Possible Donor Identified (Pre-test)
Time frame: before implementation of the intervention, average of 1 week
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on pre-test evaluation form answers.
Number of Subjects With a Possible Donor Identified (Post-test)
Time frame: after the intervention, up to 4 months
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on post-test evaluation form answers.
5 secondary outcomes
Intra Cluster Analysis to Evaluate Effectiveness of Each Teaching Style Used by Peer Educators
Time frame: Up to 4 months
Patient Engagement (Percent of Applicable Action Plan (AP) Goals Selected)
Time frame: up to 4 months
Patient Engagement (Percent of Visits Where a Patient-initiated CKD Discussion Takes Place)
Time frame: up to 4 months
Patient Engagement (Percent of Goals Met)
Time frame: up to 4 months
Amount of Time Spent by Pharmacist and Staff Per Subject
Time frame: up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33123362Easom AM, Shukla AM, Rotaru D, Ounpraseuth S, Shah SV, Arthur JM, Singh M. Home run-results of a chronic kidney disease Telemedicine Patient Education Study. Clin Kidney J. 2019 Aug 22;13(5):867-872. doi: 10.1093/ckj/sfz096. eCollection 2020 Oct.
- Background: PubMed 28546368Shukla AM, Easom A, Singh M, Pandey R, Rotaru D, Wen X, Shah SV. Effects of a Comprehensive Predialysis Education Program on the Home Dialysis Therapies: A Retrospective Cohort Study. Perit Dial Int. 2017 Sep-Oct;37(5):542-547. doi: 10.3747/pdi.2016.00270. Epub 2017 May 25.
- Background: PubMed 19446160Neil N, Guest S, Wong L, Inglese G, Bhattacharyya SK, Gehr T, Walker DR, Golper T. The financial implications for Medicare of greater use of peritoneal dialysis. Clin Ther. 2009 Apr;31(4):880-8. doi: 10.1016/j.clinthera.2009.04.004.
- Background: PubMed 18371531Waterman AD, Browne T, Waterman BM, Gladstone EH, Hostetter T. Attitudes and behaviors of African Americans regarding early detection of kidney disease. Am J Kidney Dis. 2008 Apr;51(4):554-62. doi: 10.1053/j.ajkd.2007.12.020. Epub 2008 Mar 6.
- Background: PubMed 25427285Szczech LA, Stewart RC, Su HL, DeLoskey RJ, Astor BC, Fox CH, McCullough PA, Vassalotti JA. Primary care detection of chronic kidney disease in adults with type-2 diabetes: the ADD-CKD Study (awareness, detection and drug therapy in type 2 diabetes and chronic kidney disease). PLoS One. 2014 Nov 26;9(11):e110535. doi: 10.1371/journal.pone.0110535. eCollection 2014.
- Background: PubMed 24349134Weis L, Metzger M, Haymann JP, Thervet E, Flamant M, Vrtovsnik F, Gauci C, Houillier P, Froissart M, Letavernier E, Stengel B, Boffa JJ; NephroTest Study Group. Renal function can improve at any stage of chronic kidney disease. PLoS One. 2013 Dec 13;8(12):e81835. doi: 10.1371/journal.pone.0081835. eCollection 2013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manisha Singh, MD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CKD "What You Need To Know" Workbook System, CKD Action Plan and CKD Web-based Resource List in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Can Choose a Dialysis Modality by the End of the Study. (time frame: up to 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138419, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.