Trial Outcomes & Findings for Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis (NCT NCT03595748)

NCT ID: NCT03595748

Last Updated: 2024-09-19

Results Overview

Each month all enrolled patients will be evaluated for ED visit or hospitalization encounters by both self-report and medical record review. The events will be tabulated each month up to an 18-month period. The rates of the composite event during this period will be determined as event rate per patient-month.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 199 participants
• Primary outcome timeframe: During 3 months of intervention and up to 15 months of follow up (up to 18 months observation total)
• Results posted on: 2024-09-19

Participant Flow

Mentors were not included in the trial. Patient participants or mentees were the subjects who were followed for the primary and secondary outcomes. Mentors implemented the intervention.

Participant milestones

Measure	Peer Mentorship Intervention This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care This arm of mentees will not get a telephone intervention by an assigned mentee
Overall Study STARTED	101	98
Overall Study COMPLETED	62	56
Overall Study NOT COMPLETED	39	42

Reasons for withdrawal

Measure	Peer Mentorship Intervention This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care This arm of mentees will not get a telephone intervention by an assigned mentee
Overall Study Death	11	12
Overall Study Withdrawal by Subject	28	29
Overall Study Protocol Violation	0	1

Baseline Characteristics

Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

Baseline characteristics by cohort

Measure	Peer Mentorship Intervention n=100 Participants This arm of patient participants will be assigned to weekly telephone calls with an assigned mentor over a period of 3 months. They will have observational follow up for 9-15 months thereafter. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake, how to improve understanding of and adherence to dialysis.	Usual Care n=94 Participants This arm of patient participants will not get a telephone intervention by an assigned mentor. They will have 12-18 months of observational follow up by study team.	Total n=194 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 12.8 • n=5 Participants	53.3 years STANDARD_DEVIATION 13.8 • n=7 Participants	54.2 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	29 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	59 Participants n=7 Participants	110 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants	59 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	14 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	94 participants n=7 Participants	194 participants n=5 Participants
Number of hospitalizations in the one year prior to enrollment	2.09 Hospitalizations STANDARD_DEVIATION 2.66 • n=5 Participants	2.27 Hospitalizations STANDARD_DEVIATION 2.56 • n=7 Participants	2.18 Hospitalizations STANDARD_DEVIATION 2.61 • n=5 Participants
Number of ED visits in the year prior to enrollment.	2.07 ED visits STANDARD_DEVIATION 2.75 • n=5 Participants	2.11 ED visits STANDARD_DEVIATION 2.83 • n=7 Participants	2.09 ED visits STANDARD_DEVIATION 2.78 • n=5 Participants

PRIMARY outcome

Timeframe: During 3 months of intervention and up to 15 months of follow up (up to 18 months observation total)

Population: Patient participants receiving maintenance dialysis

Each month all enrolled patients will be evaluated for ED visit or hospitalization encounters by both self-report and medical record review. The events will be tabulated each month up to an 18-month period. The rates of the composite event during this period will be determined as event rate per patient-month.

Outcome measures

Measure	Peer Mentorship Intervention n=99 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=95 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
ED Visits and Hospitalizations	0.244 cases per person-months Interval 0.214 to 0.276	0.287 cases per person-months Interval 0.254 to 0.322

SECONDARY outcome

Timeframe: up to 18 months

Average change in number of monthly minutes of dialysis missed by intervention participants as compared to usual care participants over the study period.

Outcome measures

Measure	Peer Mentorship Intervention n=99 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=95 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Change From Baseline to End of Follow-up in Average Number of Monthly Missed Dialysis Minutes	2.4704 minutes per person per month Standard Error 2.146	0.3293 minutes per person per month Standard Error 2.122

SECONDARY outcome

Timeframe: up to 18 months

Population: Per month rate of increase or decline in mean interdialytic weight gain

Change in monthly average fluid weight gain in-between dialysis treatments by intervention participants as compared to usual care participants over study period.

Outcome measures

Measure	Peer Mentorship Intervention n=99 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=95 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Change From Baseline to End of Follow-up in Average Monthly Interdialytic Weight Gain in Patient Participants.	0.0061 kg/month Standard Error 0.0464	-0.0733 kg/month Standard Error 0.0462

SECONDARY outcome

Timeframe: up to 18 months

Change in mean monthly albumin levels in intervention mentees as compared to control mentees over follow up period.

Outcome measures

Measure	Peer Mentorship Intervention n=99 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=95 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Change From Baseline in Average Monthly Serum Albumin Levels	0.0062 g/dL per month Standard Error 0.0021	0.0084 g/dL per month Standard Error 0.0021

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Efficacy of intervention to change dialysis knowledge will be assessed based on the Score on Chronic Hemodialysis Knowledge Survey (CHeKs) in patient participants assigned to the peer-mentor intervention as compared patient participants assigned to usual care. Mean change in baseline scores are reported.

The CHeKs survey consists of 23 multiple choice questions. Total score is determined by summing all correct items (blank items or items with more than one answer are considered incorrect). A positive mean percentage score is indicative of an improvement from baseline and demonstrated increased participant knowledge of hemodialysis care; whereas, a negative mean percentage score is indicative of decrease in demonstrated hemodialysis knowledge.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change Dialysis Knowledge in Mentees	0.54 Percentage Change Standard Error 1.41	0.35 Percentage Change Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Efficacy of intervention to change curriculum specific dialysis knowledge in patient participants was assessed based on a change from baseline in score on the "Chronic Hemodialysis Knowledge Survey (CHeKs) Plus" knowledge assessment, an assessment developed by the study team focused on topic covered in mentor training sessions, in patient-participants assigned to intervention as compared patient participants assigned to usual care.

The CHeKs Plus survey is a multiple-choice training quiz which contains 8 questions. A mean change from baseline score was reported for the groups. A positive mean change demonstrated an improvement in specific hemodialysis knowledge; whereas, a decrease in score is indicative of decrease in specific hemodialysis knowledge.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change Curriculum Specific Dialysis Knowledge in Patient Participants	5.21 Percentage Change Standard Error 2.34	1.04 Percentage Change Standard Error 2.47

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Change from baseline in General Health will be assessed using the GH perceptions subscale domain of the RAND SF-36 QoL Health Survey. The GH subscale consists of 5 specific items (Items 1 and 33-36) of the health survey. Item 1 is scored on a 5 point scale ranging from 1 ("Excellent") to 5 ("Very Poor") and items 33-36 are scored on a 5 point scale ranging from 1 ("Definitely True") to 5 ("Definitely False"). Responses are then coded to the RAND scoring key for the respective items as follows: Items 1, 34, and 36 are inversely coded such that a precoded item value of 1 ("Excellent" or "Definitely True") is assigned a final item value of "5" and so forth. Items 33 and 35 maintain the same final item value as precoded item value. This yields an overall scoring range of 5-25 for final value items. No transformation was done. For this measure a mean change from baseline for GH is calculated. A positive mean score is indicative of improved self-perception of general health from baseline.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Change From Baseline in General Health (GH) Perceptions Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care	2.42 score on a scale Standard Error 2.93	6.10 score on a scale Standard Error 3.24

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Change from baseline in Physical Functioning (PF) will be assessed using the PF subscale domain of the RAND SF-36 QoL Health Survey. The PF subscale consists of 10 specific items (Items 3-12) of the health survey. These items are scored on a 3 point scale ranging from 1 ("Yes, limited a lot") to 3 ("No, not limited at all") The raw responses values and coded final item values are identical yielding an overall scoring range of 10-30 for final value items. No additional transformation is done. For this measure a mean change from baseline for PF is calculated. A positive mean score is associated with an improved self-perception of physical functioning from baseline.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Change From Baseline in Physical Functioning (PF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care	0.33 score on a scale Standard Error 3.51	6.16 score on a scale Standard Error 3.90

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Change from baseline in Social Functioning (SF) will be assessed using the SF subscale domain of the RAND SF-36 QoL Health Survey. The SF subscale consists of 2 items (Items 20 and 32) of the health survey. Item 20 is scored on a 5 point scale ranging from 1 ("Not at all") to 5 ("Extremely") and Item 32 is scored on a 5 point scale ranging from 1 ("All of the time") to 5 ("None of the time"). Item 20 is then inversely coded such that a precoded item value of 1 ("Not at all") is assigned a final item value of "5" and a precoded item value of 5 ("Extremely") is assigned a final item value of 1. Item 32 maintains the same final item value as precoded item value. This yields an overall scoring range of 2-10 for final value items. No additional transformation is done. For this measure a mean change from baseline for SF is calculated. A positive mean score is indicative of improved self-perception of physical functioning from baseline.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Change From Baseline in Social Functioning (SF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care	1.27 score on a scale Standard Error 5.18	1.60 score on a scale Standard Error 5.71

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Effectiveness of intervention to change kidney self-efficacy will be assessed using the "Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)"

The PKDSMS is a unidimensional eight-item scale used to assess a participant's perceived ability to self-manage their condition. Participant responses are scored on a 1-5 Likert scale, with 1 representing "strongly disagree" to 5 representing "strongly agree." Total scoring ranges from 8-40 with higher scores indicating better perception of self-efficacy and self-management. For this study, mean change from baseline score is reported. A positive mean item score is indicative of better perception of self-efficacy and self-management; whereas, a negative mean item score is indicative of worsening perception of self-efficacy and self-management.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Effectiveness of Intervention to Change From Baseline to End of Follow-up, Scores on the Perceived Knowledge/Dialysis Self-Management Scale	2.36 score on a scale Standard Error 0.77	1.01 score on a scale Standard Error 1.11

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Scores on CESD-R (Center for Epidemiologic Studies Depression Scale Revised) in mentees assigned to intervention as compared to control mentees will be used to assess depressive symptoms.

CESD. The 20 items in CESD-R scale measure symptoms of depression in nine different groups. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. Response values are as follows:

Not at all or less than one day = 0 1-2 days = 1 3-4 days = 2 5-7 days = 3 Nearly every day for 2 weeks = 3

For this study, mean change from baseline score is reported. A positive mean score is indicative of improved depression symptoms; whereas, a negative mean score is indicative of worsening depression symptoms.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change From Baseline to End of Follow up, Scores on the CESD-R Scale in Participants Assigned to Peer Mentor Intervention as Compared to Participants Assigned to Usual Care	-0.12 score on a scale Standard Error 0.07	0.05 score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Perception of social support is measured using scores obtained from the "Multi-dimensional Scale of Perceived Social Support (MSPSS)." The MSPSS is a 12-item scale which measures perceived adequacy of social support from three sources: family, friends, and a significant other. The MSPSS is scored on a 7-point Likert scale (1-7) with 1 representing "very strongly disagree" and 7 representing "very strongly agree" for an overall possible range of 12-84. The total score can also be calculated as a mean score (dividing by 12). Higher scores are indicative of higher perceptions of adequate social support. For this study, change from baseline score of mean score is reported. A positive mean score is indicative of improved perceptions of social support; whereas, a negative mean score is indicative of decreased perceptions of social support.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Social Support by Intervention Mentees as Compared to Usual Care Mentees	0.13 score on a scale Standard Error 0.17	-0.07 score on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time

Kidney disease self-management was determined by calculating the change in scores from baseline to end of follow up period using the "Kidney Disease Behavioral Index (KDBI)" survey tool. KDBI is a novel 16-item scale based on the Summary of Diabetes Self-Care Activities. It is used measure an individual's self-reported completion of specific self-care activities required for kidney disease self-management.

The participant is asked to report how often they perform these activities over the past month and the 4-point response options range from 0 = "very slightly or not at all" to 3 = "quite a bit." Scores are summed over the 16 items for a possible scoring range of 0-48, with higher scores indicating a greater engagement in self-care behaviors for kidney disease management. For this study, mean change from baseline score is reported. A positive mean score is indicative of improvement of an individual's completion of specific self-care activities required for kidney disease management.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change From Baseline Kidney Disease Self-management Behaviors in Intervention Mentees as Compared to Usual Care Mentees	1.14 score on a scale Standard Error 0.7	1.14 score on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

The Brief Kidney Cope (Brief "K" [Kidney]-COPE) survey was modified from the Brief COPE for use on study. The Brief K-COPE omits two scales of the full COPE, reduces others to two items per scale, and adds a scale. The Brief K-COPE is intended to foster a wider examination of coping in naturally occurring settings. The Brief K-COPE asks what the participant has done over the past month when a problem taking care of their kidney disease was encountered. The scale consists of 28-items (14 subscales composed of 2 items) scored from 0-3 where "0" = I didn't do this AT ALL, to "3" = I've been doing this A LOT, for a possible scoring range of 0-84. For this study, mean change from baseline score is reported. A positive mean score is indicative of improvement of an individual's ability to cope with their kidney disease; whereas, a negative mean score is indicative a decreased ability to cope with their kidney disease.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change From Baseline Kidney Disease Coping Ability in Intervention Mentees as Compared to Usual Care Mentees	-0.09 score on a scale Standard Error 0.09	0.86 score on a scale Standard Error 0.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time.

Change from baseline in Dialysis Specific Social Support was assessed using the Dialysis Specific Support Survey (developed by PI's). This survey was used to characterize the frequency of interactions between the participant and other dialysis patients. This survey consists of 6 items and the total score is the mean of the 6 items. Individual scores for the scale ranged from 1-5 where 1 = ("None of the time") and 5 = ("All of the time"), yielding a possible scoring range of 1-5. For this study, mean change from baseline score is reported. A positive mean score was reflective of more perceived dialysis social support; whereas, a negative mean score was reflective of less perceived dialysis social support.

Outcome measures

Measure	Peer Mentorship Intervention n=62 Participants This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.	Usual Care n=56 Participants This arm of mentees will not get a telephone intervention by an assigned mentee
Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Dialysis Specific Social Support by Intervention Mentees as Compared to Usual Care Mentees	0.11 score on a scale Standard Error 0.12	0.17 score on a scale Standard Error 0.13

Adverse Events

Peer Mentorship Intervention

Serious events: 64 serious events

Other events: 0 other events

Deaths: 11 deaths

Usual Care

Serious events: 66 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Measure	Peer Mentorship Intervention n=99 participants at risk This arm of patient participants will be assigned to weekly telephone calls with an assigned mentor over a period of 3 months. They will have observational follow up for 9-15 months thereafter. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake, how to improve understanding of and adherence to dialysis.	Usual Care n=95 participants at risk This arm of patient participants will not get a telephone intervention by an assigned mentor. They will have 12-18 months of observational follow up by study team.
Surgical and medical procedures Hospitalization	64.6% 64/99 • Number of events 171 • Adverse events were collected from time of enrollment (baseline visit) through 12-18 months of follow up or time at which patient participants and mentees were censored. Participants with hospitalizations or ED visits. Non-serious adverse events were only collected for those instances where: 1. There was embarrassment and/or stigma related to being identified as a high-risk patient 2. Distress related to concern for loss of privacy of health information by mentor disclosure 3. Distress related to telephone conversations with mentors The trial examined outcomes in patient participants and not mentors. Mentors implemented the intervention: peer mentorship.	69.5% 66/95 • Number of events 194 • Adverse events were collected from time of enrollment (baseline visit) through 12-18 months of follow up or time at which patient participants and mentees were censored. Participants with hospitalizations or ED visits. Non-serious adverse events were only collected for those instances where: 1. There was embarrassment and/or stigma related to being identified as a high-risk patient 2. Distress related to concern for loss of privacy of health information by mentor disclosure 3. Distress related to telephone conversations with mentors The trial examined outcomes in patient participants and not mentors. Mentors implemented the intervention: peer mentorship.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ladan Golestaneh

Albert Einstein College of Medicine

Phone: 718-920-5442

Email: lgolesta@montefiore.org

Results disclosure agreements

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