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

Primary Purpose

Parkinson Disease, Neurodegenerative Diseases, Movement Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participant self-assessment surveys
Phonation
Gait and balance
Memory
Dexterity
Participant open-response writing
Parkinson mPower mobile application
Sponsored by
Sage Bionetworks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Health app research, mHealth research, Mobile health research, Mobile application health research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sage BionetworksRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants with Parkinson disease

Participants without Parkinson disease

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Results of participant self-assessment surveys
Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.
Digital audio signals of sustained phonation from phonation intervention
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
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.
Sequence length from memory intervention
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
The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision. These results may also be compared with other intervention results.
App usage data for assessment of participant engagement
App usage data is used to gauge participant engagement throughout the study period. 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
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.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2016
Last Updated
October 20, 2017
Sponsor
Sage Bionetworks
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02696603
Brief Title
Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)
Acronym
mPower
Official Title
Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Bionetworks
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Neurodegenerative Diseases, Movement Disorders, Central Nervous System Diseases, Brain Diseases, Basal Ganglia Diseases, Parkinsonian Disorders
Keywords
Health app research, mHealth research, Mobile health research, Mobile application health research

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Parkinson disease
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants without Parkinson disease
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Participant self-assessment surveys
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Phonation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gait and balance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Memory
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dexterity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Participant open-response writing
Intervention Description
Qualitative participant feedback is used to assess participant engagement with, understanding of, and acceptance of app-based research.
Intervention Type
Other
Intervention Name(s)
Parkinson mPower mobile application
Intervention Description
Participants complete all described behavioral interventions via a dedicated iPhone app, Parkinson mPower.
Primary Outcome Measure Information:
Title
Results of participant self-assessment surveys
Description
Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.
Time Frame
Through study completion, an average of 1 year
Title
Digital audio signals of sustained phonation from phonation intervention
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Gyroscope and accelerometer sensor measurements from gait and balance intervention
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Sequence length from memory intervention
Description
The investigators assess the sequence length completed in the Memory intervention. These results may also be compared with other intervention results.
Time Frame
Through study completion, an average of 1 year
Title
iPhone screen touch sensor data on rhythm, speed, and location of taps from dexterity intervention
Description
The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision. These results may also be compared with other intervention results.
Time Frame
Through study completion, an average of 1 year
Title
App usage data for assessment of participant engagement
Description
App usage data is used to gauge participant engagement throughout the study period. These results may also be compared with other intervention results.
Time Frame
Through study completion, an average of 1 year
Title
Qualitative analysis of participant open-response and app usage data to assess participant acceptance of app-based research
Description
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.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Mangravite, PhD
Phone
2066672102
Email
lara.mangravite@sagebase.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Suver, PhD
Phone
2066672128
Email
christine.suver@sagebase.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Mangravite, PhD
Organizational Affiliation
Sage Bionetworks
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sage Bionetworks
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Suver, PhD
Phone
206-667-2128
Email
christine.suver@sagebase.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
Citation
Corsi, P.M. (1972). Human memory and the medial temporal region of the brain (Ph.D.). McGill University.
Results Reference
background
PubMed Identifier
11296689
Citation
Kessels RP, van Zandvoort MJ, Postma A, Kappelle LJ, de Haan EH. The Corsi Block-Tapping Task: standardization and normative data. Appl Neuropsychol. 2000;7(4):252-8. doi: 10.1207/S15324826AN0704_8.
Results Reference
background
PubMed Identifier
23431395
Citation
Klucken J, Barth J, Kugler P, Schlachetzki J, Henze T, Marxreiter F, Kohl Z, Steidl R, Hornegger J, Eskofier B, Winkler J. Unbiased and mobile gait analysis detects motor impairment in Parkinson's disease. PLoS One. 2013;8(2):e56956. doi: 10.1371/journal.pone.0056956. Epub 2013 Feb 19.
Results Reference
background
PubMed Identifier
26776193
Citation
Chaibub Neto E, Bot BM, Perumal T, Omberg L, Guinney J, Kellen M, Klein A, Friend SH, Trister AD. PERSONALIZED HYPOTHESIS TESTS FOR DETECTING MEDICATION RESPONSE IN PARKINSON DISEASE PATIENTS USING iPHONE SENSOR DATA. Pac Symp Biocomput. 2016;21:273-84.
Results Reference
result
Links:
URL
http://parkinsonmpower.org
Description
mPower study website
Available IPD and Supporting Information:
Available IPD/Information Type
Data description
Available IPD/Information URL
http://www.nature.com/articles/sdata201611
Available IPD/Information Comments
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.

Learn more about this trial

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

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