Clinical trial NCT03978806: Prosperando: Fostering Resilience on Dialysis
Official title: Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Racial/Ethnic Minorities on Dialysis
Keywords: Latino
Hispanic
Dialysis
Navigator
Community health worker
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-06-07
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. Self-identify as Latino
2. Age between 18 and 90 years
3. Diagnosed with end-stage kidney disease
4. Received standard (thrice-weekly HD) for at least 3 months
5. No active substance use (e.g. heavy etoh or opiates)
6. Speak English or Spanish as a primary language
7. Participants must be able to provide informed consent

Exclusion Criteria:

1. Active suicidal intent
2. Present or past psychosis or bipolar disorder
3. Patient to receive kidney transplantation in the next 3 months

Primary outcomes:
measure: Interdialytic weight gain
timeFrame: Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion
Secondary outcomes:
measure: Kidney Dialysis Quality of Life Short Form - 36 questions
timeFrame: Change from baseline health-related quality of life up to 24 months
measure: Hemodialysis shortening
timeFrame: 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.
measure: Hemodialysis adherence
timeFrame: 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.
measure: Albumin
timeFrame: 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.
measure: Potassium
timeFrame: 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.
measure: Phosphorus
timeFrame: Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention
measure: Social determinants of health composite survey
timeFrame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
measure: Self-Efficacy
timeFrame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
measure: Patient Activation Measure
timeFrame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
measure: Emergency Department visits and hospitalizations
timeFrame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
measure: Social Isolation
timeFrame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
measure: Qualitative interviews to assess acceptability
timeFrame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
measure: Kidney transplantation Questions derived/tailored from two previously published questionnaires.
timeFrame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Fresenius Medical Care Rocky Mountain Dialysis
state: Colorado
Study officials:
References:
citation: Cukor D, Ver Halen N, Asher DR, Coplan JD, Weedon J, Wyka KE, Saggi SJ, Kimmel PL. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2014 Jan;25(1):196-206. doi: 10.1681/ASN.2012111134. Epub 2013 Oct 10.
citation: Lora CM, Ricardo AC, Brecklin CS, Fischer MJ, Rosman RT, Carmona E, Lopez A, Balaram M, Nessel L, Tao KK, Xie D, Kusek JW, Go AS, Lash JP. Recruitment of Hispanics into an observational study of chronic kidney disease: the Hispanic Chronic Renal Insufficiency Cohort Study experience. Contemp Clin Trials. 2012 Nov;33(6):1238-44. doi: 10.1016/j.cct.2012.07.012. Epub 2012 Jul 27.
citation: Cervantes L, Jones J, Linas S, Fischer S. Qualitative Interviews Exploring Palliative Care Perspectives of Latinos on Dialysis. Clin J Am Soc Nephrol. 2017 May 8;12(5):788-798. doi: 10.2215/CJN.10260916. Epub 2017 Apr 12.
citation: Cervantes L, Linas S, Keniston A, Fischer S. Latinos With Chronic Kidney Failure Treated by Dialysis: Understanding Their Palliative Care Perspectives. Am J Kidney Dis. 2016 Feb;67(2):344-7. doi: 10.1053/j.ajkd.2015.09.026. Epub 2015 Nov 20. No abstract available.
citation: Cervantes L, Chonchol M, Hasnain-Wynia R, Steiner JF, Havranek E, Hull M, Rice J, Kendrick J, Alamillo X, Camacho C, Fischer S. Peer Navigator Intervention for Latinos on Hemodialysis: A Single-Arm Clinical Trial. J Palliat Med. 2019 Jul;22(7):838-843. doi: 10.1089/jpm.2018.0439. Epub 2019 Jan 31.
citation: Cervantes L, Hull M, Keniston A, Chonchol M, Hasnain-Wynia R, Fischer S. Symptom Burden among Latino Patients with End-Stage Renal Disease and Access to Standard or Emergency-Only Hemodialysis. J Palliat Med. 2018 Sep;21(9):1329-1333. doi: 10.1089/jpm.2017.0663. Epub 2018 May 30.
citation: Cervantes L, Zoucha J, Jones J, Fischer S. Experiences and Values of Latinos with End Stage Renal Disease: A Systematic Review of Qualitative Studies. Nephrol Nurs J. 2016 Nov-Dec;43(6):479-493.
citation: Fischer SM, Cervantes L, Fink RM, Kutner JS. Apoyo con Carino: a pilot randomized controlled trial of a patient navigator intervention to improve palliative care outcomes for Latinos with serious illness. J Pain Symptom Manage. 2015 Apr;49(4):657-65. doi: 10.1016/j.jpainsymman.2014.08.011. Epub 2014 Sep 18.