Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Physical Activity Metric 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM
Arms & Interventions
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.
Intervention: Activity Monitoring (Device)
Outcomes
Primary Outcomes
Physical Activity Metric 1
Time Frame: Daily, through study completion, average 1 year
steps per day
Physical Activity Metric 2
Time Frame: Daily, through study completion, average 1 year
Minutes of aerobic physical activity per day (moderate to vigorous physical activity)
Secondary Outcomes
- 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)
Investigators
Miriam Rafferty
Principal Investigator
Shirley Ryan AbilityLab