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
- 1
- 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
研究组 & 干预措施
peer navigator
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.
干预措施: Active Comparator: peer navigator (Behavioral)
Control Arm (standard of care)
Standard of care
干预措施: Placebo Comparator: Control Arm (standard of care) (Other)
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 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.)
- Kidney Dialysis Quality of Life Short Form - 36 questions(Change from baseline health-related quality of life up to 24 months)
- 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))
- 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))