N/A N=199 Randomized Prevention

Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

Dialysis

Bottom Line

View on ClinicalTrials.gov: NCT03595748 ↗

Enrolled (actual)

199

Serious AEs

67.0%

Results posted

Sep 2024

Primary outcome: Primary: ED Visits and Hospitalizations — 0.244; 0.287 cases per person-months

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Peer mentorship (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Albert Einstein College of Medicine
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY ED Visits and Hospitalizations	0.244; 0.287	—
SECONDARY Change From Baseline to End of Follow-up in Average Number of Monthly Missed Dialysis Minutes	2.4704; 0.3293	—
SECONDARY Change From Baseline to End of Follow-up in Average Monthly Interdialytic Weight Gain in Patient Participants.	0.0061; -0.0733	—
SECONDARY Change From Baseline in Average Monthly Serum Albumin Levels	0.0062; 0.0084	—
SECONDARY Efficacy of Intervention to Change Dialysis Knowledge in Mentees	0.54; 0.35	—
SECONDARY Efficacy of Intervention to Change Curriculum Specific Dialysis Knowledge in Patient Participants	5.21; 1.04	—
SECONDARY 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; 6.10	—
SECONDARY 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; 6.16	—
SECONDARY 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; 1.60	—
SECONDARY Effectiveness of Intervention to Change From Baseline to End of Follow-up, Scores on the Perceived Knowledge/Dialysis Self-Management Scale	2.36; 1.01	—
SECONDARY 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; 0.05	—
SECONDARY 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; -0.07	—
SECONDARY Efficacy of Intervention to Change From Baseline Kidney Disease Self-management Behaviors in Intervention Mentees as Compared to Usual Care Mentees	1.14; 1.14	—
SECONDARY Efficacy of Intervention to Change From Baseline Kidney Disease Coping Ability in Intervention Mentees as Compared to Usual Care Mentees	-0.09; 0.86	—

Summary

This project tests a peer mentor intervention to improve outcomes in patients with end-stage renal disease (ESRD). The investigators will train peer mentors to deliver social support and to provide information and motivation in order to improve adherence behaviors and self management practices in assigned mentees who are also patients on maintenance hemodialysis. The intervention will consist of a weekly telephone call between mentor and mentee, over a period of 3 months. The study will recruit patients at 7 dialysis facilities (5 in the Bronx, NY and 2 in Nashville, TN) and randomize the patients to the peer mentorship intervention versus usual care. The primary outcome will be the sum of number of emergency department visits and hospitalizations during 3 months of intervention and 9 or 15 months of follow-up observation.

Eligibility Criteria

Inclusion Criteria

Age >21 years

One of the following:

One or more hospitalizations or ED visits in the previous month
>1 missed treatment or 2 shortened dialysis treatments in the last month
use of catheter as only access
>4% intradialytic weight gain
serum albumin less than 3.5 in the last month
Incident dialysis patient
Willing to give informed consent and to be randomized and to allow a telephone intervention with mentors
Speaks Spanish or English

Exclusion Criteria

Intellectual disability/ active mental illness or active substance abuse
less than a 6- month life expectancy
not a patient at one of the participating dialysis facilities

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03595748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.