- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05400720
Peer Support In Dialysis
September 19, 2023 updated by: Satellite Healthcare
Peer Support In Dialysis: A Feasibility Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jugjeet Atwal
- Phone Number: 669-266-6317
- Email: atwalj@satellitehealth.com
Study Contact Backup
- Name: Wael Hussein, MD
- Phone Number: 650-404-3600
- Email: husseinw@satellitehealth.com
Study Locations
-
-
California
-
Mountain View, California, United States, 94040
- Satellite Healthcare Mountain View
-
Mountain View, California, United States, 94040
- WellBound Mountain View
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mentee
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mentor
Time Frame: 6 - 12 months
|
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.
|
6 - 12 months
|
Mentee
Time Frame: 1 month
|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mentor Perspectives
Time Frame: 6-12month
|
Evaluation of recruitment, training and program.
Data collection will be through the Mentor Recruitment and Training Evaluation form and through focus group discussions
|
6-12month
|
Mentee Perspectives
Time Frame: 1-4 weeks
|
Peer Mentorship Program Evaluation - Mentee form to be completed by the mentee to collect data on the mentees perspective of the program
|
1-4 weeks
|
Support Staff Perspectives
Time Frame: 3,6,9 and 12 months
|
Peer Mentorship Program Evaluation - Staff to be completed by the center staff to collect data on their perspective of the program
|
3,6,9 and 12 months
|
Mentor - Mentee Matching
Time Frame: 1 month
|
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).
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wael Hussein, MD, Satellite Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Collins, K. (2016). NKF Peers Mentoring Program. National Kidney Foundation Journal of Nephrology Social Work, 40(2), 25-33.
- Fida'Husain, H. K., & Johan, A. (2020). Effects of Peer Support Program on Self-Management in Patients with End-Stage Renal Disease Undergoing Hemodialysis.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Actual)
May 1, 2023
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIH131_Peer Mentoring
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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