Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

NCT03595748 | Completed Results DMC

• 2 other identifiers: 2017-8531R18DK118471
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dialysis

Keywords

Hospitalizations; Dialysis patients; Peer mentorship

Outcome Measures

Primary Outcomes (1)

• ED Visits and Hospitalizations

  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.

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

Secondary Outcomes (13)

• Change From Baseline to End of Follow-up in Average Number of Monthly Missed Dialysis Minutes

  up to 18 months

• Change From Baseline to End of Follow-up in Average Monthly Interdialytic Weight Gain in Patient Participants.

  up to 18 months

• Change From Baseline in Average Monthly Serum Albumin Levels

  up to 18 months

• Efficacy of Intervention to Change Dialysis Knowledge in Mentees

  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

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

Other Outcomes (1)

• 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

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

Study Arms (2)

Peer mentorship intervention

EXPERIMENTAL

This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months.

Behavioral: Peer mentorship

Usual Care

NO INTERVENTION

This arm of mentees will not get a telephone intervention by an assigned mentee

Interventions

Peer mentorship BEHAVIORAL

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.

Peer mentorship intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Vanderbilt University Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Albert Einstein College of Medicine/Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Golestaneh L, Melamed M, Kim RS, St Clair Russell J, Heisler M, Villalba L, Perry T, Cavanaugh KL. Peer mentorship to improve outcomes in patients on hemodialysis (PEER-HD): a randomized controlled trial protocol. BMC Nephrol. 2022 Mar 5;23(1):92. doi: 10.1186/s12882-022-02701-1.

  PMID: 35247960 DERIVED

Results Point of Contact

• Title: Dr. Ladan Golestaneh
• Organization: Albert Einstein College of Medicine

lgolesta@montefiore.org

718-920-5442

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 23, 2018
• Study Start: April 1, 2019
• Primary Completion: July 2, 2022
• Study Completion: September 2, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)