Trial Outcomes & Findings for Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe) (NCT NCT03171545)

NCT ID: NCT03171545

Last Updated: 2026-01-14

Results Overview

Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1431 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2026-01-14

Participant Flow

Unit of analysis: Hemodialysis Facilities

Participant milestones

Measure	No Intervention Patients in clinic receive usual care.	Patient Activation This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.	Provider Education This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider This arm includes both Patient Activation and Provider Education interventions
Baseline STARTED	382 5	346 5	410 5	293 5
Baseline COMPLETED	377 5	342 5	401 5	286 5
Baseline NOT COMPLETED	5 0	4 0	9 0	7 0
Intervention STARTED	377 5	342 5	401 5	286 5
Intervention COMPLETED	323 5	307 5	348 5	247 5
Intervention NOT COMPLETED	54 0	35 0	53 0	39 0
Follow up STARTED	323 5	307 5	348 5	247 5
Follow up COMPLETED	291 5	285 5	327 5	230 5
Follow up NOT COMPLETED	32 0	22 0	21 0	17 0

Reasons for withdrawal

Measure	No Intervention Patients in clinic receive usual care.	Patient Activation This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.	Provider Education This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider This arm includes both Patient Activation and Provider Education interventions
Baseline Withdrawal by Subject	0	0	1	2
Baseline Transferred out of clinic	4	0	2	0
Baseline Death	1	2	1	5
Baseline Recovered renal function	0	0	1	0
Baseline Received transplant	0	0	1	0
Baseline No longer receiving in-center hemodialysis	0	2	3	0
Intervention Withdrawal by Subject	2	0	0	4
Intervention Transferred out of clinic	12	9	17	9
Intervention Death	26	16	29	14
Intervention Received transplant	7	5	3	6
Intervention No longer receiving in-center hemodialysis	7	4	4	6
Intervention Lost to Follow-up	0	1	0	0
Follow up Withdrawal by Subject	1	1	0	0
Follow up Transferred out of clinic	4	4	12	7
Follow up Death	18	12	5	8
Follow up Received transplant	4	1	0	1
Follow up No longer receiving in-center hemodialysis	4	2	1	0
Follow up Lost to Follow-up	1	2	3	1

Baseline Characteristics

Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

Baseline characteristics by cohort

Measure	No Intervention n=382 Participants Patients in clinic receive usual care.	Patient Activation n=346 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.	Provider Education n=410 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=293 Participants This arm includes both Patient Activation and Provider Education interventions	Total n=1431 Participants Total of all reporting groups
Age, Continuous	65.45 years STANDARD_DEVIATION 13.92 • n=14 Participants	63.58 years STANDARD_DEVIATION 14.72 • n=10 Participants	59.90 years STANDARD_DEVIATION 13.36 • n=24 Participants	61.66 years STANDARD_DEVIATION 14.70 • n=78 Participants	62.63 years STANDARD_DEVIATION 14.27 • n=713 Participants
Sex: Female, Male Female	163 Participants n=14 Participants	154 Participants n=10 Participants	162 Participants n=24 Participants	115 Participants n=78 Participants	594 Participants n=713 Participants
Sex: Female, Male Male	219 Participants n=14 Participants	192 Participants n=10 Participants	248 Participants n=24 Participants	178 Participants n=78 Participants	837 Participants n=713 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants	0 Participants n=78 Participants	2 Participants n=713 Participants
Race (NIH/OMB) Asian	6 Participants n=14 Participants	6 Participants n=10 Participants	9 Participants n=24 Participants	3 Participants n=78 Participants	24 Participants n=713 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=14 Participants	2 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	5 Participants n=713 Participants
Race (NIH/OMB) Black or African American	115 Participants n=14 Participants	91 Participants n=10 Participants	233 Participants n=24 Participants	130 Participants n=78 Participants	569 Participants n=713 Participants
Race (NIH/OMB) White	252 Participants n=14 Participants	233 Participants n=10 Participants	157 Participants n=24 Participants	147 Participants n=78 Participants	789 Participants n=713 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=14 Participants	14 Participants n=10 Participants	10 Participants n=24 Participants	13 Participants n=78 Participants	42 Participants n=713 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	71 Participants n=14 Participants	68 Participants n=10 Participants	38 Participants n=24 Participants	32 Participants n=78 Participants	209 Participants n=713 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	307 Participants n=14 Participants	265 Participants n=10 Participants	353 Participants n=24 Participants	245 Participants n=78 Participants	1170 Participants n=713 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=14 Participants	13 Participants n=10 Participants	19 Participants n=24 Participants	16 Participants n=78 Participants	52 Participants n=713 Participants
Dialysis Session Stability	0.197 Proportion of sessions STANDARD_DEVIATION 0.215 • n=14 Participants	0.198 Proportion of sessions STANDARD_DEVIATION 0.212 • n=10 Participants	0.175 Proportion of sessions STANDARD_DEVIATION 0.206 • n=24 Participants	0.177 Proportion of sessions STANDARD_DEVIATION 0.213 • n=78 Participants	0.187 Proportion of sessions STANDARD_DEVIATION 0.212 • n=713 Participants

PRIMARY outcome

Timeframe: 24 weeks

Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100.

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Dialysis Session Stability	0.172 Proportion of sessions Standard Deviation 0.190	0.182 Proportion of sessions Standard Deviation 0.205	0.202 Proportion of sessions Standard Deviation 0.217	0.199 Proportion of sessions Standard Deviation 0.204

SECONDARY outcome

Timeframe: 24 weeks

Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions (presented as average throughout 24 week intervention period)

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Fluid Adherence	2.35 Kg Standard Deviation 0.93	2.34 Kg Standard Deviation 1.01	2.12 Kg Standard Deviation 0.87	2.18 Kg Standard Deviation 1.18

SECONDARY outcome

Timeframe: 24 weeks

Measured as the average number of minutes of prescribed dialysis time missed per week during intervention period (number of prescribed minutes-number of actual minutes/24 week intervention period).

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Dialysis Adherence - Average Weekly Minutes Missed Over Intervention Period	5.28 average weekly minutes Standard Deviation 10.58	4.89 average weekly minutes Standard Deviation 11.69	5.23 average weekly minutes Standard Deviation 13.48	4.21 average weekly minutes Standard Deviation 9.05

SECONDARY outcome

Timeframe: 24 weeks

Measured as the average number of missed sessions per week during the intervention period (number of prescribed sessions-number of actual sessions/24 week intervention period).

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Dialysis Adherence - Average Weekly Sessions Missed During Intervention Period	0.028 average proportion of sessions missed Standard Deviation 0.061	0.032 average proportion of sessions missed Standard Deviation 0.077	0.004 average proportion of sessions missed Standard Deviation 0.008	0.008 average proportion of sessions missed Standard Deviation 0.041

SECONDARY outcome

Timeframe: 24 weeks

Measured at midweek session as patient recovery time after dialysis, reported on a survey item on an ordinal scale from "within minutes" to "did not recover before the next scheduled dialysis session." Responses grouped into three categories for analysis: "did not recover," "recovered before reaching home," and "recovered on same day of treatment." Sessions categorized as "recovered before reaching home" used for comparison between study arms.

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Patient Symptoms - Post-dialysis Recovery Time	0.178 Proportion session recovery before home Standard Deviation 0.091	0.158 Proportion session recovery before home Standard Deviation 0.108	0.141 Proportion session recovery before home Standard Deviation 0.106	0.181 Proportion session recovery before home Standard Deviation 0.091

SECONDARY outcome

Timeframe: 24 weeks

Measured as the total number symptoms reported by the patient at each session (each symptom treated as one, then added to create total symptoms).

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Patient Symptoms - Symptom Burden	0.051 Average symptoms reported per session Standard Deviation 0.123	0.063 Average symptoms reported per session Standard Deviation 0.133	0.045 Average symptoms reported per session Standard Deviation 0.095	0.069 Average symptoms reported per session Standard Deviation 0.154

SECONDARY outcome

Timeframe: post-intervention survey

Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1). MCS (mental component summary) subscale ranges from 5.8 - 69.9; higher scores represent better functioning.

Outcome measures

Measure	Provider Education n=158 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=132 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=162 Participants Patients in clinic receive usual care.	Patient Activation n=125 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Quality of Life-KDQOL - MCS	54.58 Score Standard Deviation 8.30	54.89 Score Standard Deviation 8.67	53.85 Score Standard Deviation 8.73	52.62 Score Standard Deviation 10.16

SECONDARY outcome

Timeframe: post-intervention survey

Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1). PCS (physical component summary) ranges from 7.3 - 70.1; higher scores represent better functioning.

Outcome measures

Measure	Provider Education n=158 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=132 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=162 Participants Patients in clinic receive usual care.	Patient Activation n=125 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Quality of Life-KDQOL - PCS	39.49 Score Standard Deviation 11.70	36.18 Score Standard Deviation 10.99	35.98 Score Standard Deviation 10.05	38.01 Score Standard Deviation 10.36

SECONDARY outcome

Timeframe: 24 weeks

Hospitalization rates, measured as a total number of hospital admission for any reason per total patients year ("all-cause hospitalizations")

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=286 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=377 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Hospitalization	1.37 hospitalizations per patient year Interval 1.2 to 1.54	1.23 hospitalizations per patient year Interval 1.04 to 1.42	1.55 hospitalizations per patient year Interval 1.37 to 1.74	1.15 hospitalizations per patient year Interval 0.098 to 1.32

SECONDARY outcome

Timeframe: 24 weeks

Mortality rates, measured as a total number of deaths due to any cause per 100 patient years during the study period ("all-cause mortality").

Outcome measures

Measure	Provider Education n=401 Participants This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Patient and Provider n=285 Participants This arm includes both Patient Activation and Provider Education interventions	No Intervention n=378 Participants Patients in clinic receive usual care.	Patient Activation n=342 Participants This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.
Mortality	14.85 Deaths per 100 patient years Interval 9.14 to 50.56	10.44 Deaths per 100 patient years Interval 4.76 to 16.11	16.99 Deaths per 100 patient years Interval 10.69 to 23.28	9.30 Deaths per 100 patient years Interval 4.43 to 14.17

Adverse Events

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 45 deaths

Patient Activation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 30 deaths

Provider Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 35 deaths

Patient and Provider

Serious events: 0 serious events

Other events: 0 other events

Deaths: 27 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tiffany Veinot

University of Michigan

Phone: 734-615-8281

Email: tveinot@umich.edu

Results disclosure agreements

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