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Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595748
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval)
First Posted : July 23, 2018
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Ladan Golestaneh, Albert Einstein College of Medicine

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 15 months of follow-up observation.

Condition or disease Intervention/treatment Phase
Dialysis Behavioral: Peer mentorship Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peer Mentorship to Improve Outcomes in Patients on Maintenance Hemodialysis
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Peer mentorship intervention
This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months.
Behavioral: Peer mentorship
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.

No Intervention: Usual Care
This arm of mentees will not get a telephone intervention by an assigned mentee



Primary Outcome Measures :
  1. Rate of ED visits and Hospitalizations [ Time Frame: 18 months ]
    Composite outcome


Secondary Outcome Measures :
  1. Rate of missed or cut dialysis treatments [ Time Frame: 18 months ]
    Mean weekly missed minutes of dialysis treatments by intervention mentees as compared to control mentees during the intervention and follow-up periods

  2. Mean monthly interdialytic weight gain in intervention mentees as compared to control mentees during the intervention and follow-up periods [ Time Frame: 18 months ]
    Mean monthly amount of changed fluid weight in-between dialysis treatments by intervention mentees as compared to control mentees during intervention and follow-up periods.

  3. Mean monthly albumin levels [ Time Frame: 18 months ]
    The monthly albumin levels in intervention mentees as compared to control mentees during intervention and follow-up periods.

  4. Efficacy of intervention to change dialysis knowledge in mentees [ Time Frame: 3 months (immediately post intervention) and 18 months ]

    The scores on Chronic Hemodialysis Knowledge Survey (CHeKS) and knowledge assessments in mentees assigned to intervention as compared mentees assigned to control.

    CHeKS: percent correct out of a total of 23 questions


  5. Efficacy of intervention to change curriculum specific dialysis knowledge in mentees [ Time Frame: 3 months (immediately post intervention) and 18 months ]

    The scores on Chronic Hemodialysis Knowledge Survey (CHeKS) plus knowledge assessments in mentees assigned to intervention as compared mentees assigned to control.

    CHeKS Plus: percent correct out of a total of 8 questions


  6. Efficacy of intervention to change quality of life in intervention mentees as compared to control mentees [ Time Frame: At 3 months (immeditely post intervention) and 18 months. ]

    The scores on SF36 Health Survey(36 item short form health survey by RAND) in mentees assigned to intervention as compared to control mentees.

    For the SF-36 Health Survey, the scoring varies depending on question with some questions having a scale from 1-6 and others having a scale from 1-3. All items are scored so a high score defines a more favorable health state.(https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html)


  7. Efficacy of intervention to change self-efficacy by intervention mentees as compared to usual care mentees [ Time Frame: At 3 months and 18 months. ]

    Scores on "Perceived Dialysis Self Management Scale(PKDSMS)" and Kidney "Disease Self Management Behavioral Index(KDBI)" in mentees assigned to intervention as compared to mentees assigned to control.

    PKDSMS: scores on a scale from 1 to 5 for each of 8 items, with 1 representing "strongly agree" to 5 representing "strongly disagree.

    KDBI: scores on a scale of 1 to 4 with 1 representing "not at all" to 4 representing "all the time"


  8. Efficacy of intervention to change curriculum taught dialysis knowledge in intervention mentees as compared to usual care mentees [ Time Frame: 3 months (immediately post intervention) and 18 months ]

    The scores on the Chronic Hemodialysis Knowledge Survey-Plus (CHeKS Plus) (developed by investigators) assessment in mentees assigned to intervention as compared mentees assigned to control.

    CHeKS Plus: percent correct out of a total of 8 questions


  9. Efficacy of intervention to change coping ability in intervention mentees as compared to usual care mentees [ Time Frame: At 3 months and 18 months. ]
    The score on Brief KCOPE in mentees assigned to intervention as compared to control mentees. For the brief KCOPE (developed by C.S. Carver (1997)): Scale 1-4 with 1 indication not at all and 4 indicating " doing it a lot".

  10. Efficacy of intervention to change depression scores in intervention mentees as compared to usual care mentees [ Time Frame: At 3 months and 18 months. ]
    The scores on CESD-10 (Center for Epidemiologic Studies Depression Scale Revised)in mentees assigned to intervention as compared to control mentees. For the CESD-R10 questions have a scale of 1-4 with 1 indicating rarely or none of the time and 4 indicating all of the time. (https://cesd-r.com/)

  11. Efficacy of intervention to change perception of social support by intervention mentees as compared to usual care mentees [ Time Frame: At 3 months and 18 months. ]

    Scores on the "Multi-dimensional Scare of Perceived Social Support(MSPSS)" and "Dialysis Specific Social Support Survey"(developed by PI's) in mentees assigned to intervention as compared to mentees assigned to control. MSPSS: scores on a scale of 1-7 with 1 representing "very strongly disagree" and 7 representing "very strongly agree".

    Dialysis specific social support survey: scores on a scale from 1-5 with 1 indicating "none of the time" and 5 indication " all of the time".



Other Outcome Measures:
  1. To test the attendance of mentor subjects at planned training programs [ Time Frame: once at 4 weeks from beginning of training ]

    To test the feasibility of a training program conducted in a central location by the investigators over 4, 2 hours sessions, attendance records will be checked and reported a ratio of those who showed up on time over the total number expected.

    The investigators will review attendance records, number of make-up training sessions needed and they will do a qualitative review of formative and summative assessments completed by trainee mentors. The authors will also gather data on trainee participants utilization of snacks, any late arrivals, and impression by trainers of participation.


  2. Acceptability of training program [ Time Frame: once at 4 weeks from beginning of training ]
    To test the acceptability of the curriculum training the investigators will record the number of make-up training sessions required in order to complete all training for all mentors.

  3. Efficacy of training program to change the amount of knowledge exhibited by mentors. [ Time Frame: once at 4 weeks from beginning of training ]
    To test the efficacy of the training the investigators will do a pre- and post- comparison of scores on the CHeKS mentors at time 0 (during initial assessment) and post-mentor training (at the end of the last training module).

  4. Feasibility of the intervention [ Time Frame: every 3 months (at the end of the mentee intervention interval) ]
    The investigators will track the sum of duration of telephone contact made between mentors and their assigned mentees during the 3-month intervention period.

  5. Efficacy of training program to support mentoring skills by the trained mentors [ Time Frame: 3 months ]

    The investigators will track the self-assessment of performance by mentors after each intervention period using the "Self-Assessment by Mentors at Quarterly Intervals" tool developed by the study staff.

    The "Self-Assessment by Mentors at Quarterly Intervals" survey is a "free text" questionnaire which will under qualitative review by the investigators.


  6. Efficacy of training program to change the amount of curriculum-focused knowledge exhibited by mentors [ Time Frame: 3 months ]
    To test the efficacy of the training the investigators will do a pre- and post- score comparison of on the curriculum focused: "CHeKS PLus" at time 0 (during initial assessment) and post-training (at the end of the last training module)

  7. Acceptability of the intervention [ Time Frame: 3 months ]
    The investigators will also do a qualitative analysis of monthly recorded conversations (recorded by mentors) on a monthly basis for each mentee/mentor conversation.

  8. Efficacy of training program to help mentors assist intervention mentees with coping skills [ Time Frame: 3 months ]

    Investigators will the Health Care Climate Questionnaire (HCCQ)(https://selfdeterminationtheory.org/questionnaires) to measure the performance of mentors from the perspective of their assigned mentees.

    The HCCQ long form scale is from 1-7 with 1 indicating "strongly disagree" and 7 indicating "strongly agree".


  9. Efficacy of training program to help mentors perform well in their tasks [ Time Frame: 3 months ]

    "Checklist for mentee assessment of mentors"(developed by study staff after adaptation from "Peer Up" program) to measure the performance of mentors from the perspective of their assigned mentees.

    "Checklist for mentee assessment of mentors" scale of 1-7 with 1 indicating "strongly disagree" and 7 indicating "strongly agree"




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595748


Locations
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United States, New York
Albert Einstein College of Medicine/Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
Vanderbilt University Medical Center
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Responsible Party: Ladan Golestaneh, Professor, Nephrology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03595748    
Other Study ID Numbers: 2017-8531
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ladan Golestaneh, Albert Einstein College of Medicine:
Hospitalizations
Dialysis patients
Peer mentorship