Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 40
- 主要终点
- Feasibility of Virtual Visits for Parkinson Disease
研究概览
简要总结
Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following:
- To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care;
- To show that such an approach can improve quality of life;
- To establish that the telemedicine can enhance the quality of care; and
- To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.
详细描述
Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's "usual care" supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater
- •No better alternative explanation for the parkinsonism
- •Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing
- •Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine
- •Have a local care provider that the study team can contact
- •Live at home, in a senior housing complex, or assisted living facility
- •Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only)
- •Willing and able to provide informed consent
- •Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.
排除标准
- •Currently hospitalized
- •Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse).
- •Participation in another telemedicine study.
结局指标
主要结局
Feasibility of Virtual Visits for Parkinson Disease
时间窗: One year
Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.
Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39
时间窗: Baseline to One year
Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.
次要结局
- Minutes Spend on Last Parkinson's Disease Provider Visit(One year)
- Change in EQ-5D Index Value(baseline to one year)
- Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA(baseline to one year)
- Change in Patient Assessment of Chronic Illness Care(baseline to one year)
- Change in Montreal Cognition Assessment(baseline to one year)
- Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB(baseline to one year)
- Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2(baseline to one year)
- Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3(baseline to one year)
- Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4(baseline to one year)
研究者
Ray Dorsey
Director, Center for Human Experimental Therapeutics; Professor of Neurology
University of Rochester