Prosperando: Fostering Resilience on Dialysis
- Conditions
- Racial/Ethnic Minorities on Dialysis
- Registration Number
- NCT03978806
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- 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
- Active suicidal intent
- Present or past psychosis or bipolar disorder
- Patient to receive kidney transplantation in the next 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Interdialytic weight gain Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion 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).
- Secondary Outcome Measures
Name Time Method Hemodialysis adherence 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 defined defined as the proportion of monthly scheduled sessions missed (other than for vacation or hospitalization)
Phosphorus Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention Phosphorus
Patient Activation Measure Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) 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.'
Social Isolation Assessed twice: At time of enrollment and at time of study completion (up to 1 year) PROMIS measure
Kidney Dialysis Quality of Life Short Form - 36 questions Change from baseline health-related quality of life up to 24 months 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).
Hemodialysis shortening 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 shortening: Defined as shortening the hemodialysis session by greater than or equal to 10 minutes.
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. Potassium
Kidney transplantation Questions derived/tailored from two previously published questionnaires. Assessed twice: At time of enrollment and at time of study completion (up to 1 year) 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.
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. Albumin
Emergency Department visits and hospitalizations Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) Number of Emergency Department (ED) visits and hospitalizations, length of stay
Social determinants of health composite survey Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) Several questions from various previously validated surveys that assess social determinants of health.
Self-Efficacy Assessed at twice: At time of enrollment and at time of study completion (up to 1 year) Patient-Reported Outcomes Measurement Information System (PROMIS) measure to assess self-efficacy
Qualitative interviews to assess acceptability Assessed twice: At time of enrollment and at time of study completion (up to 1 year) 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).
Trial Locations
- Locations (1)
Fresenius Medical Care Rocky Mountain Dialysis
🇺🇸Denver, Colorado, United States