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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

up to 4 months

Results posted on

2026-01-07

Participant Flow

Participant milestones

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

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

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 months

Population: 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 months

Population: 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 week

Population: 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 months

Population: 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 week

Population: 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 months

Population: 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 months

Population: 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 months

Population: 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 months

Population: 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 months

Population: 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 months

Population: 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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Self Study (SS)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control (Ctrl)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 5018379556

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place