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Peer Support In Dialysis

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mentoring

About this trial

This is an interventional supportive care trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Mentor Patient Participants Inclusion criteria:

Patients living with dialysis or kidney transplant, who volunteer to support other patients.
Mentor participants agree to complete the CMS End Stage Renal Disease Network Peer Mentoring training program (https://www.kidneylearninghub.com/patients-peer-mentoring-program/ ) and follow the guidelines for participation in the program.

Mentor Patient Participants Exclusion criteria:

Age <18 years.
Patient cannot communicate in English.
Concerns raised by the clinical team that may expose the mentor, mentee, staff, or the program to risks, as identified by the clinical team and discussed with the principal investigator.

Mentee Patient Participants Inclusion criteria:

All incident (new) dialysis patients or their care partners, within the first three months of dialysis.

Prevalent dialysis patients or their care partners identified by the clinical team to need peer support.

Mentee Patient Participants Exclusion criteria:

Age < 18 years.
Significant physical or psychological health conditions (including cognitive impairment) that would limit the patient's ability to interact with the mentor, AND care partner not available or reachable to join the program.
This criteria will be subjectively evaluated by the clinical team.

Clinical and administrative staff supporting the program inclusion criteria

referring physicians, the medical director of the center, social workers, nurses, patient care technicians (PCT), certified clinical hemodialysis technicians (CCHT), and administrative staff.
Support staff are those who interact with mentors or mentees as part of their routine work.
Formally participate in supporting the program by identifying candidates, introducing them to the program, or providing them with support.

Sites / Locations

Satellite Healthcare Mountain View
WellBound Mountain View

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mentee

Arm Description

Participants will be approached by a mentor, exchange experiences and invite the prospective mentee to the program. Those interested to continue will undergo matching based on their desired criteria.

Outcomes

Primary Outcome Measures

Mentor

Number of patients registering to become mentors, percent of those registered completing mentor training and percent of trained mentors who meet at least one mentee.

Mentee

Number and proportion of patients starting dialysis, or prevalent dialysis patients identified by the clinical team to need peer support, who receive an introductory peer mentor visit. Number and % of mentees who indicate interest to continue with more peer mentoring visits.

Secondary Outcome Measures

Mentor Perspectives

Evaluation of recruitment, training and program. Data collection will be through the Mentor Recruitment and Training Evaluation form and through focus group discussions

Mentee Perspectives

Peer Mentorship Program Evaluation - Mentee form to be completed by the mentee to collect data on the mentees perspective of the program

Support Staff Perspectives

Peer Mentorship Program Evaluation - Staff to be completed by the center staff to collect data on their perspective of the program

Mentor - Mentee Matching

Preferences about matching (n and % for age range, gender, race, language, social conditions, specific dialysis experiences [e.g. Peritoneal Dialysis / Home HemoDialysis / transplant], and others).

Full Information

NCT ID

NCT05400720

First Posted

May 23, 2022

Last Updated

September 19, 2023

Sponsor

Satellite Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT05400720

Brief Title

Peer Support In Dialysis

Official Title

Peer Support In Dialysis: A Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

June 6, 2022 (Actual)

Primary Completion Date

May 1, 2023 (Actual)

Study Completion Date

May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Satellite Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Peer mentoring is an approach used to support patients through their experience. In the End Stage Kidney Disease community many patients find out about their kidney failure without warning. This study is designed to test the feasibility of a structured peer support program, specifically, patient uptake, engagement and patient and staff perspectives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

We aim to conduct the study over 6 to 12 months to obtain enough experience to enable feasibility evaluation. Mentor pool sample size: We anticipate having about 10 patients in the mentors' pool during the study period. Mentee sample size: We anticipate approaching between 20 to 30 dialysis patients over the study period. Supporting team: All members of the supporting staff will be invited to participate.

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mentee

Arm Type

Experimental

Arm Description

Participants will be approached by a mentor, exchange experiences and invite the prospective mentee to the program. Those interested to continue will undergo matching based on their desired criteria.

Intervention Type

Behavioral

Intervention Name(s)

Mentoring

Intervention Description

At least one meeting between the mentor and mentee will occur to share experiences and see if the mentee would like to continue meeting with a mentor

Primary Outcome Measure Information:

Title

Mentor

Description

Number of patients registering to become mentors, percent of those registered completing mentor training and percent of trained mentors who meet at least one mentee.

Time Frame

6 - 12 months

Title

Mentee

Description

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Mentor Perspectives

Description

Evaluation of recruitment, training and program. Data collection will be through the Mentor Recruitment and Training Evaluation form and through focus group discussions

Time Frame

6-12month

Title

Mentee Perspectives

Description

Peer Mentorship Program Evaluation - Mentee form to be completed by the mentee to collect data on the mentees perspective of the program

Time Frame

1-4 weeks

Title

Support Staff Perspectives

Description

Peer Mentorship Program Evaluation - Staff to be completed by the center staff to collect data on their perspective of the program

Time Frame

3,6,9 and 12 months

Title

Mentor - Mentee Matching

Description

Preferences about matching (n and % for age range, gender, race, language, social conditions, specific dialysis experiences [e.g. Peritoneal Dialysis / Home HemoDialysis / transplant], and others).

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Mentor Patient Participants Inclusion criteria: Patients living with dialysis or kidney transplant, who volunteer to support other patients. Mentor participants agree to complete the CMS End Stage Renal Disease Network Peer Mentoring training program (https://www.kidneylearninghub.com/patients-peer-mentoring-program/ ) and follow the guidelines for participation in the program. Mentor Patient Participants Exclusion criteria: Age <18 years. Patient cannot communicate in English. Concerns raised by the clinical team that may expose the mentor, mentee, staff, or the program to risks, as identified by the clinical team and discussed with the principal investigator. Mentee Patient Participants Inclusion criteria: All incident (new) dialysis patients or their care partners, within the first three months of dialysis. OR Prevalent dialysis patients or their care partners identified by the clinical team to need peer support. Mentee Patient Participants Exclusion criteria: Age < 18 years. Significant physical or psychological health conditions (including cognitive impairment) that would limit the patient's ability to interact with the mentor, AND care partner not available or reachable to join the program. This criteria will be subjectively evaluated by the clinical team. Clinical and administrative staff supporting the program inclusion criteria referring physicians, the medical director of the center, social workers, nurses, patient care technicians (PCT), certified clinical hemodialysis technicians (CCHT), and administrative staff. Support staff are those who interact with mentors or mentees as part of their routine work. Formally participate in supporting the program by identifying candidates, introducing them to the program, or providing them with support.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wael Hussein, MD

Organizational Affiliation

Satellite Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Satellite Healthcare Mountain View

City

Mountain View

State/Province

California

ZIP/Postal Code

94040

Country

United States

Facility Name

WellBound Mountain View

City

Mountain View

State/Province

California

ZIP/Postal Code

94040

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29722062

Citation

Bennett PN, St Clair Russell J, Atwal J, Brown L, Schiller B. Patient-to-patient peer mentor support in dialysis: Improving the patient experience. Semin Dial. 2018 Sep;31(5):455-461. doi: 10.1111/sdi.12703. Epub 2018 May 2.

Results Reference

background

Citation

Collins, K. (2016). NKF Peers Mentoring Program. National Kidney Foundation Journal of Nephrology Social Work, 40(2), 25-33.

Results Reference

background

Citation

Fida'Husain, H. K., & Johan, A. (2020). Effects of Peer Support Program on Self-Management in Patients with End-Stage Renal Disease Undergoing Hemodialysis.

Results Reference

background

PubMed Identifier

35373037

Citation

Flythe JE, Narendra JH, Yule C, Manivannan S, Murphy S, Lee SD, Strigo TS, Peskoe S, Pendergast JF, Boulware LE, Green JA. Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access. Kidney360. 2021 Feb 26;2(4):708-720. doi: 10.34067/KID.0007812020. eCollection 2021 Apr 29.

Results Reference

background

PubMed Identifier

34717865

Citation

Hussein WF, Bennett PN, Schiller B. Innovations to Increase Home Hemodialysis Utilization: The Transitional Care Unit. Adv Chronic Kidney Dis. 2021 Mar;28(2):178-183. doi: 10.1053/j.ackd.2021.02.009.

Results Reference

background

PubMed Identifier

26594739

Citation

Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. doi: 10.1177/1539449215578649.

Results Reference

background

PubMed Identifier

29281772

Citation

St Clair Russell J, Southerland S, Huff ED, Thomson M, Meyer KB, Lynch JR. A Peer-to-Peer Mentoring Program for In-Center Hemodialysis: A Patient-Centered Quality Improvement Program. Nephrol Nurs J. 2017 Nov-Dec;44(6):481-496.

Results Reference

background

Links:

URL

https://partnershipforpatients.cms.gov/about-the-partnership/patient-and-family-engagement/the-patient-and-family-engagement.html

Description

Centers for Medicare and Medicaid Services (CMS). (2021). Partnership for patients.

URL

https://esrdncc.org/en/patients/peer-mentoring-resources/

Description

ESRD National Coordinating Center. (2021). ESRD Networks Peer Mentor Program.

URL

http://dx.doi.org/10.37526/1526-744X.2021.48.4.399

Description

Lessons Learned: Implementation of a Peer-to-Peer Mentor Program in Individuals Requiring Hemodialysis.

Learn more about this trial

Peer Support In Dialysis

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