Prosperando: Fostering Resilience on Dialysis

Study Overview
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Brief Summary
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Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and suffer a disproportionate burden of social challenges that impacts their well-being. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed the feasibility of a 1-arm intervention of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and adherence (using motivational interviewing & patient activation). This trial will build on the Amos work as a small Randomized Controlled Trial (RCT). The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-intervention; 2) conduct a pilot RCT of the peer navigator intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on interdialytic weight gain (primary outcome) as well as health-related quality of life, patient activation, and hemodialysis adherence (secondary outcomes).

Detailed Description
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The goal of this project is to assess the feasibility and acceptability of a pilot RCT of a culturally tailored peer-navigator (PN) intervention to improve patient-centered and clinical outcomes for Latino patients with end-stage kidney disease (ESKD). We will compare a culturally tailored intervention that includes a PN to control (standard care). In the culturally tailored intervention, the bilingual PN will provide support with social challenges during 5 visits. We will assess the feasibility of (1) referral, (2) recruitment, (3) retention, (4) intervention implementation, and (5) data collection. We will also assess various outcomes including inter-dialytic weight gain and other adherence and patient-centered outcomes. Specific Aim 1: Conduct a pilot RCT of the peer navigator intervention to assess feasibility, acceptability, as well as outcomes of the proposed peer navigator intervention. Hypothesis 1: A culturally tailored intervention that consists of a bilingual/culture-concordant peer navigator that provides support with social challenges and support with adherence using motivational interviewing for Latino end-stage kidney disease (ESKD) patients, is feasible and acceptable.

Official Title
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Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis

Conditions
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Racial/Ethnic Minorities on Dialysis

Intervention / Treatment
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* Behavioral: Active Comparator: peer navigator
* Other: Placebo Comparator: Control Arm (standard of care)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify as Latino Age between 18 and 90 years Diagnosed with end-stage kidney disease Received standard (thrice-weekly HD) for at least 3 months No active substance use (e.g. heavy etoh or opiates) Speak English or Spanish as a primary language Participants must be able to provide informed consent Exclusion Criteria: Active suicidal intent Present or past psychosis or bipolar disorder Patient to receive kidney transplantation in the next 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a pilot RCT (randomized controlled trial) of a 3 month intervention of Latino ESRD patients that will be randomized to one of two arms: 1) PN Arm, in which a bilingual PN provides support with social factors and support with adherence using motivational interviewing during 5 visits or 2) Control (standard care) Arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: peer navigator<br>The first PN visit will take place within 1-2 weeks of consent. Each of the 5 subsequent PN visits will take place every 1-2 weeks. We expect patients to complete the intervention within 2-3 months of consent. The function of the initial visit is to establish trust and ensure a more personal approach with participants. The community-based PN intervention is grounded in core Latino values (e.g. trust, personalized relationships). The core elements of the PN intervention include patient motivational interviewing as well as patient activation, empowerment (e.g. help with scheduling of healthcare appointments and re-scheduling of missed HD sessions), education (e.g. education of ESKD and need for renal replacement therapy), and social challenges (e.g. access to resources for transportation, benefits, immigration issues). The duration, individuals present during the visit, and content discussed will be documented in the visit form. | Behavioral: Active Comparator: peer navigator<br>* The intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.<br>|
| Placebo Comparator: Control Arm (standard of care)<br>Standard of care | Other: Placebo Comparator: Control Arm (standard of care)<br>* Control patients will have met the same inclusion and exclusion criteria as intervention patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interdialytic weight gain | Inter-dialytic weight gain will be calculated as the monthly average of the difference between the pre-dialysis weight and the weight at the end of the previous dialysis session, divided by determined dry weight, expressed as a percentage of change in weight per day (%Δkg per day). | Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Dialysis Quality of Life Short Form - 36 questions | KDQOL(Kidney Disease Quality Of Life) - Short Form 36 (SF-36). The KDQOL Short Form-36 (KDQOL-SF-36), a 36 item survey with five subscales (Physical Component Summary, Mental Component Summary, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life). The KDQOL-SF-36 are scored linearly (with higher score indicating better quality of life) on a range of 0-100 using the developer-recommended scoring (available at https://www.rand.org/health-care/surveys_tools/kdqol.html). | Change from baseline health-related quality of life up to 24 months | 
| Hemodialysis shortening | Hemodialysis shortening: Defined as shortening the hemodialysis session by greater than or equal to 10 minutes. | This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion. | 
| Hemodialysis adherence | Hemodialysis adherence defined defined as the proportion of monthly scheduled sessions missed (other than for vacation or hospitalization) | This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion. | 
| Albumin | Albumin | This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion. | 
| Potassium | Potassium | This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion. | 
| Phosphorus | Phosphorus | Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention | 
| Social determinants of health composite survey | Several questions from various previously validated surveys that assess social determinants of health. | Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) | 
| Self-Efficacy | Patient-Reported Outcomes Measurement Information System (PROMIS) measure to assess self-efficacy | Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) | 
| Patient Activation Measure | Patient Activation Measure has 13 questions, each item is rated on a four-point scale (1 strong disagree to 4 strong agree, with additional 'non-applicable.' Level 1 (less than 47) indicates 'not believing activation is important.' Level 2 (47 to 55.1) indicates 'a lack of knowledge and confidence to take action.' Level 3 (55.2 to 67) indicates 'beginning to take action.' Level 4 (greater than 67) indicates 'taking action.' | Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) | 
| Emergency Department visits and hospitalizations | Number of Emergency Department (ED) visits and hospitalizations, length of stay | Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) | 
| Social Isolation | PROMIS measure | Assessed twice: At time of enrollment and at time of study completion (up to 1 year) | 
| Qualitative interviews to assess acceptability | 10 participants will be interviewed using semi-structured approach. The results will be a thematic analysis (that ties in the themes and subthemes with illustrative quotes). | Assessed twice: At time of enrollment and at time of study completion (up to 1 year) | 
| Kidney transplantation Questions derived/tailored from two previously published questionnaires. | Kidney transplantation interest in pursuing, placement on list, receipt of transplantation. Questions were derived and tailored from two studies: Ayanian NEJM 1999;341:1661-9 & Bouleware American J of Transplantation 2005;5:1503-1512. Some are yes/no questions and others are on a Likert Scale. | Assessed twice: At time of enrollment and at time of study completion (up to 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latino, Hispanic, Dialysis, Navigator, Community health worker