Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Physical Activity Metric 1
研究概览
简要总结
The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.
详细描述
Remote therapeutic monitoring (RTM) is a reimbursable clinical service. Pilot investigation conducted by our lab demonstrated promise that this service is feasible to add to clinical care. It is unclear still if RTM is able to provide clinical benefit to patients including improving and sustaining physical activity (PA) and exercise behaviors over a longer period of time (>1 year). Our central hypothesis is that the addition of RTM to physical activity, both in a skilled rehabilitation program and within a home program, will improve long term outcomes related to physical activity including self-efficacy for exercise, consistent participation in home exercise recommendations, and quality of life in people living with PD and MS. Thus the specific aims of this study are as follows:
- To assess PA and exercise behaviors over 1-year period using a remote therapeutic monitoring platform
a. We will track steps per day, minutes of aerobic activity per week, and frequency of workouts including flexibility, balance, and resistance training. 2. To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.
- Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community
- •Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis
- •Personal goal and willingness to address physical activity
- •Have a smart phone (Datos Health app is compatible with any Smart phone device)
- •Willing to accept Datos' Terms and Conditions
排除标准
- •Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM
研究组 & 干预措施
Remote Therapeutic Monitoring
Participants will receive 1 year of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors.
干预措施: Activity Monitoring (Device)
结局指标
主要结局
Physical Activity Metric 1
时间窗: Daily, through study completion, average 1 year
steps per day
Physical Activity Metric 2
时间窗: Daily, through study completion, average 1 year
Minutes of aerobic physical activity per day (moderate to vigorous physical activity)
次要结局
- Quality of Life from PROMIS 10-b(Completed every 3 months, through study completion, average of 1 year)
- Quality of Life from PROMIS-29(Completed every 3 months, through study completion, average of 1 year)
- Exercise Self Efficacy(Completed every other month, through study completion, average of 1 year)
研究者
Miriam Rafferty
Principal Investigator
Shirley Ryan AbilityLab