Remote Therapeutic Monitoring Exercise Tracking

April 14, 2024 updated by: Miriam Rafferty, Shirley Ryan AbilityLab

Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. 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.

    1. Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: Activity Monitoring
Tracking participants step activity, workout frequency, minutes in target heart rate zone, and type of exercises completed over 1 year period. Goals will be set and customized by a research physical therapist to participants based on best practice recommendations.
Other Names:
  • Datos Health App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Metric 1
Time Frame: Daily, through study completion, average 1 year
steps per day
Daily, through study completion, average 1 year
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)
Daily, through study completion, average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Self Efficacy
Time Frame: Completed every other month, through study completion, average of 1 year
sums of 9 items with total scores ranging from 0-90; higher scores indicating higher self-efficacy.
Completed every other month, through study completion, average of 1 year
Quality of Life from PROMIS 10-b
Time Frame: Completed every 3 months, through study completion, average of 1 year
PROMIS 10-b short form which is 10 items measuring mobility difficulty, scores are summed and then translated to t-score.
Completed every 3 months, through study completion, average of 1 year
Quality of Life from PROMIS-29
Time Frame: Completed every 3 months, through study completion, average of 1 year
PROMIS-29 measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and sleep disturbance).
Completed every 3 months, through study completion, average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Miriam Rafferty, PT, PhD, Shirley Ryan AbilityLab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00219979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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