Providing Specialty Care to Individuals With Parkinsonism Directly in Their Homes Via Web-based Video Conferencing- A Comparative Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The investigators will conduct a two-arm, parallel group, randomized comparative effectiveness study across two sites to increase specialty access and improve care for individuals with Parkinsonism and their caregivers. Twenty individuals with Parkinsonism will be recruited from Johns Hopkins University and the University of Rochester (approximately ten from each site). They will then be randomized to either continue their usual in-person care with a specialist or to receive care with their specialist via telemedicine in their home. Following an in-person baseline/screening visit, approximately ten individuals in the first arm (virtual house calls) will receive three visits with a movement disorder specialist via telemedicine (using web-based video conferencing) in their home. Approximately ten individuals in the second (control) arm will receive three in-person visits at an academic medical center with the same specialists. Approximately two weeks after the completion of each clinical visit, a nurse or coordinator will call the patient to call to address any questions or ensure appropriate understanding of the recommendation (for both telemedicine and control arms). Overall, the study - consistent with a national priority for comparative effectiveness research - will compare the use of telemedicine to manage Parkinsonism to usual care.
详细描述
- Abstract
The research's overall objective is to improve care for individuals with Parkinsonism. Parkinsonism is clinically determined as the presence of at least 2 of the following: 1) rest tremor, 2) bradykinesia, 3) cogwheel rigidity, or 4) difficulty with gait or balance. The most common cause of Parkinsonism is Parkinson disease. Parkinson disease is a chronic condition whose burden is growing both in the United States and globally. However, access to specialty care is limited chiefly to urban areas and is frequently inefficient. One way to remove geographic barriers to care is through the use of web-based video conferencing (telemedicine).
To evaluate the study's aims, the investigators will conduct a seven-month randomized controlled study of twenty patients with Parkinsonism across two sites to contrast the comparative effectiveness of standard in-person specialty visits versus those conducted via web-based video conferencing (telemedicine). It is hypothesized that these "virtual house calls" will be feasible, clinically non-inferior to usual care, and economically valuable. This research will expand the geographic scope of specialty care and provide a national model for providing home-based, patient-centered, cost-effective care to those with Parkinsonism anywhere they live. 2. Objectives (include all primary and secondary objectives)
The specific objectives of the study are as follows:
Aim 1: To evaluate the feasibility of providing specialty care to individuals with Parkinsonism via web-based video conferencing (telemedicine) in their homes by calculating the proportion of specialty visits completed as scheduled.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The principal eligibility criteria for participants are the following: age greater than 30, clinical diagnosis of idiopathic Parkinsonism, ability to converse in English, ability and willingness to provide informed consent and complete study requirements, and access to a computer with broadband internet.
排除标准
- •The main exclusion criterion is a condition (e.g., prominent psychosis) that in the investigator's judgment would preclude participation in a telemedicine visit. Participants may identify a principal caregiver for optional participation in the study.
研究组 & 干预措施
In-patient care
干预措施: Usual care (Other)
Telemedicine care
干预措施: Telemedicine (Other)
结局指标
主要结局
Feasibility
时间窗: 7 months
Percentage of visits completed as scheduled, number of individuals in telemedicine arm who require in-person visit, number of in-person visits required by individuals in telemedicine arm, proportion of completed telemedicine visits versus in-person visits
次要结局
- Clinical Benefits(7 months)
- Economic impact(7 months)