Trial Outcomes & Findings for Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program (NCT NCT03229811)

Last Updated: 2025-01-31

Results Overview

Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Pre-intervention and Day 1 post-intervention

Results posted on

2025-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Pre-dialysis Education Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation	ESRD Education + ACP Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
Overall Study STARTED	0	4
Overall Study COMPLETED	0	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Pre-dialysis Education Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation	ESRD Education + ACP n=4 Participants Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	—	76 years STANDARD_DEVIATION 6.06 • n=7 Participants	76 years STANDARD_DEVIATION 6.06 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	4 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-intervention and Day 1 post-intervention

Population: No participants were randomized to standard education

Outcome measures

Outcome measures
Measure	Standard Pre-dialysis Education Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation	ESRD Education + ACP n=4 Participants Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)	—	5.75 score on a scale Standard Deviation 3.60

PRIMARY outcome

Timeframe: Immediate post-intervention

Population: No participants were randomized to standard education. One enrolled participant did not complete the post-knowledge questionnaire

Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning

Outcome measures

Outcome measures
Measure	Standard Pre-dialysis Education Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation	ESRD Education + ACP n=3 Participants Standard ESRD education + conservative kidney management and advance care planning education ESRD education + conservative kidney management and ACP education: Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)	—	8.67 score on a scale Standard Deviation 0.58

Adverse Events

Standard Pre-dialysis Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ESRD Education + ACP

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

Dr. Amaka Eneanya

Fresenius Medical Care

Phone: 267-769-5455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place