Trial Outcomes & Findings for A Pragmatic Approach to CKD Patient Education (NCT NCT05138419)
NCT ID: NCT05138419
Last Updated: 2026-01-07
Results Overview
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.
TERMINATED
NA
1 participants
up to 4 months
2026-01-07
Participant Flow
Participant milestones
| Measure |
Case Management Model (CMM)
CMM includes 3 visits of pharmacist initiated discussion of workbook content (including AP \[action plan\] and CKD web-based sites) and AP reinforcement.
|
Self Study (SS)
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.
CKD "What You Need To Know" Workbook System: 139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material
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.
CKD Web-based Resource List: CKD Patient education material used separately for control arm
Food Label reading exercise: CKD Patient education material used separately in all arms.
|
Control (Ctrl)
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.
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.
CKD Web-based Resource List: CKD Patient education material used separately for control arm
Food Label reading exercise: CKD Patient education material used separately in all arms.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Case Management Model (CMM)
CMM includes 3 visits of pharmacist initiated discussion of workbook content (including AP \[action plan\] and CKD web-based sites) and AP reinforcement.
|
Self Study (SS)
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.
CKD "What You Need To Know" Workbook System: 139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material
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.
CKD Web-based Resource List: CKD Patient education material used separately for control arm
Food Label reading exercise: CKD Patient education material used separately in all arms.
|
Control (Ctrl)
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.
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.
CKD Web-based Resource List: CKD Patient education material used separately for control arm
Food Label reading exercise: CKD Patient education material used separately in all arms.
|
|---|---|---|---|
|
Overall Study
Study terminated before participant completed.
|
0
|
0
|
1
|
Baseline Characteristics
A Pragmatic Approach to CKD Patient Education
Baseline characteristics by cohort
| Measure |
Case Management Model (CMM)
CMM includes 3 visits of pharmacist initiated discussion of workbook content (including AP \[action plan\] and CKD web-based sites) and AP reinforcement.
|
Self Study (SS)
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.
CKD "What You Need To Know" Workbook System: 139 page Workbook including CKD Action Plan, Web-Based Resources, Interactive CKD Patient education material
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.
CKD Web-based Resource List: CKD Patient education material used separately for control arm
Food Label reading exercise: CKD Patient education material used separately in all arms.
|
Control (Ctrl)
n=1 Participants
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.
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.
CKD Web-based Resource List: CKD Patient education material used separately for control arm
Food Label reading exercise: CKD Patient education material used separately in all arms.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
1 Participants
n=95 Participants
|
1 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
1 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
1 Participants
n=95 Participants
|
1 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: up to 4 monthsPopulation: Participants did not complete any protocol required assessments
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 4 monthsPopulation: Participants did not complete any protocol required assessments
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: before implementation of the intervention, average of 1 weekPopulation: Participants did not complete any protocol required assessments
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: after the intervention, up to 4 monthsPopulation: Participants did not complete any protocol required assessments
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: before implementation of the intervention, average of 1 weekPopulation: Participants did not complete any protocol required assessments
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on pre-test evaluation form answers.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: after the intervention, up to 4 monthsPopulation: Participants did not complete any protocol required assessments
Descriptive statistics will be used to examine the trend in the subjects' selection of a possible donor based on post-test evaluation form answers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: Participants did not complete any protocol required assessments
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 monthsPopulation: Participants did not complete any protocol required assessments
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 monthsPopulation: Participants did not complete any protocol required assessments
Patient Engagement will be measured by the percent of visits where a patient-initiated CKD discussion occurred
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 monthsPopulation: Participants did not complete any protocol required assessments
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 4 monthsPopulation: Participants did not complete any protocol required assessments
Pharmacist and staff will note the time spent on CKD-related issues at each visit on the study flow sheet.
Outcome measures
Outcome data not reported
Adverse Events
Case Management Model (CMM)
Self Study (SS)
Control (Ctrl)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrea Easom, APRN
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place