Racial/Ethnic Minorities on Dialysis Clinical Trial
Official title:
Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis
| Verified date | April 2024 |
| Source | University of Colorado, Denver |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | February 25, 2023 |
| Est. primary completion date | February 25, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Fresenius Medical Care Rocky Mountain Dialysis | Denver | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| University of Colorado, Denver | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 (%?kg per day). | Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion | |
| Secondary | 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 | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | Phosphorus | Phosphorus | Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Social Isolation | PROMIS measure | Assessed twice: At time of enrollment and at time of study completion (up to 1 year) | |
| Secondary | 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) | |
| Secondary | 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) |