Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Interdialytic weight gain
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
The PI will not know arm assignment.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Active suicidal intent
- •Present or past psychosis or bipolar disorder
- •Patient to receive kidney transplantation in the next 3 months
结局指标
主要结局
Interdialytic weight gain
时间窗: 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).
次要结局
- 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.)
- Phosphorus(Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention)
- Patient Activation Measure(Assessed at twice: At time of enrollment and at time of study completion (up to 1 year))
- Social Isolation(Assessed twice: At time of enrollment and at time of study completion (up to 1 year))
- 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.)
- 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.)
- 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))
- 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.)
- Emergency Department visits and hospitalizations(Assessed at twice: At time of enrollment and at time of study completion (up to 1 year))
- Social determinants of health composite survey(Assessed at twice: At time of enrollment and at time of study completion (up to 1 year))
- Self-Efficacy(Assessed at twice: At time of enrollment and at time of study completion (up to 1 year))
- Qualitative interviews to assess acceptability(Assessed twice: At time of enrollment and at time of study completion (up to 1 year))
- Kidney Dialysis Quality of Life Short Form - 36 questions(Change from baseline health-related quality of life up to 24 months)