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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02696603
Date of registration: 23/02/2016
Prospective Registration: No
Primary sponsor: Sage Bionetworks
Public title: Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower) mPower
Scientific title: Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)
Date of first enrolment: March 2015
Target sample size: 20000
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02696603
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Christine Suver, PhD
Address: 
Telephone: 206-667-2128
Email: christine.suver@sagebase.org
Affiliation: 
Name:     Lara Mangravite, PhD
Address: 
Telephone:
Email:
Affiliation:  Sage Bionetworks
Name:     Lara Mangravite, PhD
Address: 
Telephone: 2066672102
Email: lara.mangravite@sagebase.org
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Movement Disorders
Central Nervous System Diseases
Intervention(s)
Behavioral: Gait and balance
Behavioral: Phonation
Behavioral: Memory
Other: Parkinson mPower mobile application
Behavioral: Dexterity
Behavioral: Participant open-response writing
Behavioral: Participant self-assessment surveys
Primary Outcome(s)
Digital audio signals of sustained phonation from phonation intervention [Time Frame: Through study completion, an average of 1 year]
App usage data for assessment of participant engagement [Time Frame: Through study completion, an average of 1 year]
Gyroscope and accelerometer sensor measurements from gait and balance intervention [Time Frame: Through study completion, an average of 1 year]
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]
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]
Results of participant self-assessment surveys [Time Frame: Through study completion, an average of 1 year]
Sequence length from memory intervention [Time Frame: Through study completion, an average of 1 year]
Secondary Outcome(s)
Secondary ID(s)
20141369
201410711
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Robert Wood Johnson Foundation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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