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Trial record 1 of 3 for:    mPower
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Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower) (mPower)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696603
Recruitment Status : Unknown
Verified October 2017 by Sage Bionetworks.
Recruitment status was:  Recruiting
First Posted : March 2, 2016
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Sage Bionetworks

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
Parkinson Disease Neurodegenerative Diseases Movement Disorders Central Nervous System Diseases Brain Diseases Basal Ganglia Diseases Parkinsonian Disorders 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696603


Contacts
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Contact: Lara Mangravite, PhD 2066672102 lara.mangravite@sagebase.org
Contact: Christine Suver, PhD 2066672128 christine.suver@sagebase.org

Locations
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United States, Washington
Sage Bionetworks Recruiting
Seattle, Washington, United States, 98109
Contact: Christine Suver, PhD    206-667-2128    christine.suver@sagebase.org   
Sponsors and Collaborators
Sage Bionetworks
Robert Wood Johnson Foundation
Investigators
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Principal Investigator: Lara Mangravite, PhD Sage Bionetworks
Additional Information:
Study Data/Documents: Data description  This link exits the ClinicalTrials.gov site
Here we present data from mPower, a clinical observational study about Parkinson disease conducted purely through an iPhone app interface. The study interrogated aspects of this movement disorder through surveys and frequent sensor-based recordings from participants with and without Parkinson disease. Benefitting from large enrollment and repeated measurements on many individuals, these data may help establish baseline variability of real-world activity measurement collected via mobile phones, and ultimately may lead to quantification of the ebbs-and-flows of Parkinson symptoms. App source code for these data collection modules are available through an open source license for use in studies of other conditions. We hope that releasing data contributed by engaged research participants will seed a new community of analysts working collaboratively on understanding mobile health data to advance human health.

Publications of Results:
Other Publications:
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Responsible Party: Sage Bionetworks
ClinicalTrials.gov Identifier: NCT02696603    
Other Study ID Numbers: 201410711
20141369 ( Other Identifier: Western Instiutional Review Board )
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded data authorized for sharing by participants will be made available for research purposes via Synapse, Sage Bionetworks' analysis platform. Coded data is study data that does not include participants names or other directly identifying information.
Keywords provided by Sage Bionetworks:
Health app research
mHealth research
Mobile health research
Mobile application health research
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Disease
Pathologic Processes