Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson´s Disease (TeleFall).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of falls reduction
研究概览
简要总结
Falls in Parkinson's Disease (PD) are very frequent with often devastating consequences, increasing comorbidity, mortality, decreased quality of life and increased socio-health costs. In this national, single-center, single-blind, randomized, case-control study, non-demented patients with idiopathic PD with high risk of falling will be included. The main objective of this study is to determine the cost-effectiveness of a home-based, multidisciplinary tele-health intervention to decrease the risk of falling.
详细描述
In this study, PD patients using multidisciplinary tele-health intervention (study group) will be compared to age, gender-matched PD patients receiving the best standard in-office clinical management (control group). Both groups will be followed for 8 months.
The main outcome will be the comparison of incidence of falls between the study and control groups. Secondary outcomes will include the analysis of cost-effectiveness of multidisciplinary tele-health interventions.
The results of this study will allow us to study the feasibility of remote health care to prevent falls in patients with PD, allowing equity in the distribution and access to specialized health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The rater will be blind to the patient status (study vs. control).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-demented patients
- •Patients diagnosed with idiopathic Parkinson´s disease
- •Patients able to walk with a Hoehn Yahr stage < 3
排除标准
- •Non-ambulatory patients with Parkinson´s disease
- •Patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.
结局指标
主要结局
Incidence of falls reduction
时间窗: 8 months
Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors
Feasibility
时间窗: 8 months
Number of virtual videoconferences completed
次要结局
- Cost-effectiveness(8 months)
- Healt-related quality of life(8 months)
研究者
Esther Cubo
MD, PhD, Principal Investigator
Hospital Universitario de Burgos