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Clinical Trials/NCT02696603
NCT02696603
Active, not recruiting
Not Applicable

Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)

Sage Bionetworks1 site in 1 country20,000 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Sage Bionetworks
Enrollment
20000
Locations
1
Primary Endpoint
Results of participant self-assessment surveys
Status
Active, not recruiting
Last Updated
10 months ago

Overview

Brief Summary

The purpose of this study is to understand variation in the symptoms of Parkinson disease. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

Detailed Description

Living with Parkinson disease means coping with symptoms that change every day. Yet these changes are not tracked frequently enough. Most people with Parkinson disease see a clinician only once or twice a year. This study measures changes in Parkinson disease symptoms in real time using an app. The app remotely monitors Parkinson disease symptoms using surveys and the sensors on mobile devices. This study may contribute to increasing our understanding of the variability in Parkinson disease symptoms. This knowledge could be used to improve quality of life for people living with Parkinson disease.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 31, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 years
  • Have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
  • Be able to read and understand an official language of the country of participation
  • Be able to provide informed consent (i.e., pass assessment quiz)
  • Be willing to follow study procedures

Exclusion Criteria

  • Age 17 years or younger
  • Not a resident of the of a country where the app is approved for use
  • Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
  • Not be able to read and understand an official language of the country of participation
  • Not be able to give informed consent
  • Not be willing to follow study procedures

Outcomes

Primary Outcomes

Results of participant self-assessment surveys

Time Frame: Through study completion, an average of 1 year

Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.

App usage data for assessment of participant engagement

Time Frame: Through study completion, an average of 1 year

App usage data is used to gauge participant engagement throughout the study period. These results may also be compared with other intervention results.

Sequence length from memory intervention

Time Frame: Through study completion, an average of 1 year

The investigators assess the sequence length completed in the Memory intervention. These results may also be compared with other intervention results.

iPhone screen touch sensor data on rhythm, speed, and location of taps from dexterity intervention

Time Frame: Through study completion, an average of 1 year

The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision. These results may also be compared with other intervention results.

Qualitative analysis of participant open-response and app usage data to assess participant acceptance of app-based research

Time Frame: Through study completion, an average of 1 year

App usage data and qualitative participant feedback are used to assess participant understanding and acceptance of app-based research. These results may also be compared with other intervention results.

Digital audio signals of sustained phonation from phonation intervention

Time Frame: Through study completion, an average of 1 year

The investigators extract features from the digital audio signals of sustained phonations. The investigators apply feature selection and classifier algorithms and analyze these phonations using methods similar to those employed in the Parkinson Voice Initiative (http://www.parkinsonsvoice.org/science.php). These results may also be compared with other intervention results.

Gyroscope and accelerometer sensor measurements from gait and balance intervention

Time Frame: Through study completion, an average of 1 year

The investigators examine step-dependent and sequence-dependent features from gyroscope and accelerometer sensors. The investigators apply feature selection and classifier algorithms to analyze these data. These results may also be compared with other intervention results.

Study Sites (1)

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