AzTrials
AzTrials

End Stage Renal DiseaseNCT05400720

Peer Support In Dialysis

A study testing Mentoring in people with End Stage Renal Disease, run by Satellite Healthcare at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease
What is being tested?
Mentoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesUnited States
Study dates
6 Jun 2022to 1 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Satellite Healthcare Mountain View

    Mountain View, California, 94040

  • WellBound Mountain View

    Mountain View, California, 94040

Other trials in United States

About this study

Official title: 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.

Being tested
Mentoring
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MentoringBehavioural

    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

Study groups in NCT05400720
Study groupRoleWhat they receive
MenteeExperimentalParticipants 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.
Receives: Behavioral: Mentoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 - 12 months

  2. 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.

    Measured: 1 month

Secondary outcomes (4)

  1. 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

    Measured: 6-12month

  2. Mentee Perspectives

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

    Measured: 1-4 weeks

  3. Support Staff Perspectives

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

    Measured: 3,6,9 and 12 months

  4. 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).

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start6 Jun 2022
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400720
Sponsor's protocol ID
SIH131_Peer Mentoring
Status last verified
Jul 2022
First submitted
23 May 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29722062

  • 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.

    PubMed 35373037

  • 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.

    PubMed 34717865

  • 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.

    PubMed 26594739

  • 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.

    PubMed 29281772

Questions about this trial

What is this clinical trial studying?

A study testing Mentoring in people with End Stage Renal Disease, run by Satellite Healthcare at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mentor (time frame: 6 - 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05400720, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in