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

Sponsor
Sage Bionetworks (Other)
Overall Status
Unknown status
CT.gov ID
NCT02696603
Collaborator
Robert Wood Johnson Foundation (Other)
20,000
1
2
35.1
570

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Participant self-assessment surveys
  • Behavioral: Phonation
  • Behavioral: Gait and balance
  • Behavioral: Memory
  • Behavioral: Dexterity
  • Behavioral: Participant open-response writing
  • Other: Parkinson mPower mobile application
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Feb 1, 2018
Anticipated Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants with Parkinson disease

People who report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

Behavioral: Participant self-assessment surveys
At enrollment, participants are asked to complete a baseline health history and a participant-reported symptom inventory. Thereafter, participants are asked to respond to commonly used questions that assess Parkinson Disease symptoms and quality of life at regular intervals.

Behavioral: Phonation
Participants are asked to record themselves saying "Aaah" for 10 seconds using the iPhone microphone. This activity is designed to assess vocal features, including vocal tremor. The investigators extract features from the digital audio signals of these 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.

Behavioral: Gait and balance
Participants are asked to walk back and forth for 30 seconds and then stand still for 30 seconds. Gait and balance are measured by gyroscope and accelerometer sensors. The investigators examine step-dependent and sequence-dependent features from these sensors. The investigators apply feature selection and classifier algorithms to analyze these data.

Behavioral: Memory
Participants are asked to complete a visuospatial short-term memory game related to the Corsi block tapping test [Corsi, P.M. (1972)] as adapted by Kate Possin, PhD of the University of California San Francisco Memory and Aging Center (personal communication, 2015). In this activity, participants are presented with a grid of objects that change color in a set pattern. Participants are then asked to tap the objects in that same pattern. The investigators assess the sequence length completed.

Behavioral: Dexterity
Participants are asked to tap on the phone screen with alternating fingers. This test can be done with either or both hands. The investigators record the rhythm, speed, and location of these taps using the touch sensors of the iPhone screen. The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision.

Behavioral: Participant open-response writing
Qualitative participant feedback is used to assess participant engagement with, understanding of, and acceptance of app-based research.

Other: Parkinson mPower mobile application
Participants complete all described behavioral interventions via a dedicated iPhone app, Parkinson mPower.

Experimental: Participants without Parkinson disease

People who do not report a diagnosis of Parkinson disease. Participants are invited via the Parkinson mPower mobile application to complete the following behavioral interventions: Participant self-assessment surveys, Phonation, Gait and balance, Memory, Dexterity, and Participant open-response writing.

Behavioral: Participant self-assessment surveys
At enrollment, participants are asked to complete a baseline health history and a participant-reported symptom inventory. Thereafter, participants are asked to respond to commonly used questions that assess Parkinson Disease symptoms and quality of life at regular intervals.

Behavioral: Phonation
Participants are asked to record themselves saying "Aaah" for 10 seconds using the iPhone microphone. This activity is designed to assess vocal features, including vocal tremor. The investigators extract features from the digital audio signals of these 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.

Behavioral: Gait and balance
Participants are asked to walk back and forth for 30 seconds and then stand still for 30 seconds. Gait and balance are measured by gyroscope and accelerometer sensors. The investigators examine step-dependent and sequence-dependent features from these sensors. The investigators apply feature selection and classifier algorithms to analyze these data.

Behavioral: Memory
Participants are asked to complete a visuospatial short-term memory game related to the Corsi block tapping test [Corsi, P.M. (1972)] as adapted by Kate Possin, PhD of the University of California San Francisco Memory and Aging Center (personal communication, 2015). In this activity, participants are presented with a grid of objects that change color in a set pattern. Participants are then asked to tap the objects in that same pattern. The investigators assess the sequence length completed.

Behavioral: Dexterity
Participants are asked to tap on the phone screen with alternating fingers. This test can be done with either or both hands. The investigators record the rhythm, speed, and location of these taps using the touch sensors of the iPhone screen. The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision.

Behavioral: Participant open-response writing
Qualitative participant feedback is used to assess participant engagement with, understanding of, and acceptance of app-based research.

Other: Parkinson mPower mobile application
Participants complete all described behavioral interventions via a dedicated iPhone app, Parkinson mPower.

Outcome Measures

Primary Outcome Measures

  1. Results of participant self-assessment surveys [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.

  2. Digital audio signals of sustained phonation from phonation intervention [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.

  3. Gyroscope and accelerometer sensor measurements from gait and balance intervention [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.

  4. Sequence length from memory intervention [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.

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

  6. App usage data for assessment of participant engagement [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.

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age 18 years

  2. Have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)

  3. Be able to read and understand an official language of the country of participation

  4. Be able to provide informed consent (i.e., pass assessment quiz)

  5. Be willing to follow study procedures

Exclusion Criteria:
  1. Age 17 years or younger

  2. Not a resident of the of a country where the app is approved for use

  3. Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)

  4. Not be able to read and understand an official language of the country of participation

  5. Not be able to give informed consent

  6. Not be willing to follow study procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sage Bionetworks Seattle Washington United States 98109

Sponsors and Collaborators

  • Sage Bionetworks
  • Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Lara Mangravite, PhD, Sage Bionetworks

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sage Bionetworks
ClinicalTrials.gov Identifier:
NCT02696603
Other Study ID Numbers:
  • 201410711
  • 20141369
First Posted:
Mar 2, 2016
Last Update Posted:
Oct 24, 2017
Last Verified:
Oct 1, 2017

Study Results

No Results Posted as of Oct 24, 2017