跳至主要内容
临床试验/NCT02533921
NCT02533921已完成不适用

Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease?

University of Colorado, Denver6 个研究点 分布在 2 个国家目标入组 210 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
6
主要终点
Changes in Caregiver Distress

研究概览

简要总结

The purpose of this study is to improve outcomes for persons living with Parkinson's Disease (PD) and their family caregivers. The investigators hypothesize that outpatient interdisciplinary palliative care will improve patient-centered outcomes for PD patients at high-risk for poor outcomes.

详细描述

Palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease. To date there have been minimal attempts to apply these principles to PD although preliminary evidence suggests that PD patients have significant unmet needs under current models of care which may be amenable through a palliative care model. This study will provide critical information to forward this field including data on the comparative effectiveness of outpatient palliative care for PD versus current standards of care; effects of this intervention on cost and service utilization; and the characteristics of patients most likely to benefit from such an approach and the specific services most needed by PD patients and their caregivers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fluent in English
  • UK Brain Bank criteria for diagnosis of probable PD or Multiple Systems Atrophy (MSA) or Corticobasal Degeneration (CBD) or Progressive Supranuclear Palsy (PSP) or Lewy Body Dementia (LBD)
  • At high risk for poor outcomes as identified by the Palliative Care Needs Assessment Tool (PC-NAT)

排除标准

  • Immediate and urgent palliative care needs
  • Unable or unwilling to commit to study procedures including;
  • randomization,
  • study visits or
  • the addition of a neurologist to their care team
  • Presence of additional chronic medical illnesses which may require palliative services
  • Already receiving palliative care and/or hospice services.

结局指标

主要结局

Changes in Caregiver Distress

时间窗: 0 to 6 months

The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48.

Changes in the Subjects Quality of Life (QOL)

时间窗: 0 to 6 months

The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52.

次要结局

  • Changes in Patient Anxiety(0 to 6 months)
  • Changes in Patient Depression(0 to 6 months)
  • Changes in Caregiver Anxiety(0 to 6 months)
  • Changes in Caregiver Depression(0 to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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