Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease, Lewy Body Dementia and Related Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Zarit Caregiver Burden Interview short form (ZBI)
研究概览
简要总结
The purpose of this study is to learn more about the effectiveness of palliative care training for community physicians and telemedicine support services for patients and carepartners with Parkinson's disease and Lewy Body Dementia (LBD) or related conditions and their care partners. Palliative care is a treatment approach focused on improving quality of life by relieving suffering in the areas of physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Telemedicine is the use of technology that allows participants to interact with a health care provider without being physically near the provider.
详细描述
Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial comparing a novel model of providing community-based palliative care for persons living with Parkinson's disease (PD), Lewy Body Dementia (LBD) and related disorders through online communities to usual care. Our intervention includes support for both community neurologists (using the ECHO model of clinician support) as well as family caregivers and patients. Investigators hypothesize that this model of care will improve patient quality of life and caregiver burden as well as other important secondary outcomes such as patient symptom burden and clinician burnout. This study will recruit neurology providers (MD and APPs) from 24 community neurology practices. These practices will identify participants for the study who have PD, LBD or a related condition and moderate to high palliative care needs. Under usual care, community providers will deliver their usual care and center coordinators will collect data on our outcomes every 3 months. After one year of baseline data collection, 6 practices will be randomized to the intervention, which will include clinician training and coaching as well as access to online services for their patients. Per the stepped-wedge design an additional six practices will be randomized 18 months into the data collection period, six at 24 months, and the final six will enter the intervention 30 months into the data collection period to allow for 12 months intervention recruitment for all practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •PATIENT INCLUSION CRITERIA:
- •Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their community neurologist.
排除标准
- •PATIENT EXCLUSION CRITERIA:
- •Potential patient subjects who are unable or unwilling to commit to study procedures
- •Presence of additional medical illnesses which requires palliative services (e.g. metastatic cancer)
- •Already receiving palliative care or hospice services.
研究组 & 干预措施
Usual Care
Community neurologists provide their usual care to enrolled participants. The clinicians may utilize other community resources to support patients and families as per their usual practice.
干预措施: Parkinson Disease Standard Care (Other)
Online Community-Supported Palliative Care Intervention
Community neurologists get training in palliative care via teleconferences (ECHO model), in addition to other support from our team. Patients and carepartners will also have access to additional support services when their providers enter the intervention (Online support groups, tailored education)
干预措施: Online Community-Supported Palliative Care (Other)
结局指标
主要结局
Zarit Caregiver Burden Interview short form (ZBI)
时间窗: 6 Months
Primary Outcome: Caregiver (Zarit Caregiver Burden Interview ): Investigators will use the Zarit Caregiver Burden Interview (ZBI) short form to understand the specific challenges and support preferences of persons living with Parkinson disease. Range 0-48 with higher scores = more burden
Quality of Life: Alzheimer's Disease (QOL-AD)
时间窗: 6 Months
Primary Outcome: Patient (Quality of Life): Investigators will use the Quality of Life: Alzheimer's Disease (QOL-AD) to understand the specific challenges and support preferences of persons living with PD, their family care partner, and healthcare professionals, through the Quality of Life: Alzheimer's Disease (QOL-AD). Range 13-52, higher scores = better QOL
次要结局
- Carepartner Measures (FACIT-SP 12)(3, 6, 9, 12 Months)
- Patient Measures Hospital Anxiety and Depression Scale(3, 6, 9, 12 Months)
- Patient Measures Edmonton Symptom Assessment Scale(3, 6, 9, 12 Months)
- Patient Measures (PG-12)(3, 6, 9, 12 Months)
- Carepartner Measures Hospital Anxiety and Depression Scale(3, 6, 9, 12 Months)
- Patient Measures (FACIT-SP 12)(3, 6, 9, 12 Months)
研究者
Benzi Kluger, MD
Professor
University of Rochester