ITMAT/CHPS mhealth Service Introduction. Mauricio Novelo Project director, mhealth mobile device program, ITMAT/CHPS

Transcription

1 ITMAT/CHPS mhealth Service Introduction Mauricio Novelo Project director, mhealth mobile device program, ITMAT/CHPS

2 mhealth service Center for Human Phenomic Science (CHPS; formerly CTRC/GCRC), Institute for Translational Medicine and Therapeutics (ITMAT); funded by the NIH Clinical and Translational Science Award (CTSA) Facilitate mobile app development and on-going maintenance in a cost-effective manner Provide access to expertise in app user interface development, data analysis, and grantsmanship advice in order to maximize usability, impact and success of grant applications Tablet/smartwatch/smartphone equipment rental program with dataplans

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7 Mobile Device Research an NIH Priority

8 NIH Study Section Feedback

9 mhealth Service: Support for NIH grant applications

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11 Components of the mphenomic platform 1. ResearchAide: Logistics, Peer networks 2. Symptom assessment: Daily/weekly symptom surveys, secure photo share, ecological momentary assessments 3. Biometric data collection: Activity monitors, heart rate 4. Treatment fidelity monitoring: Recording subject interactions with app to watch educational videos, etc.

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16 1. ResearchAide: Subject Recruitment and Logistics

17 2. Symptom Assessment: Neurosurgery Post-op Care example Jared Pisapia, MD and Jayesh Thawani, MD Mobile-optimized web app accessible from an internet browser, Android (left) or ios (right)

18 Symptom Assessment: Research Staff Dashboard

19 3. Biometric data: Accelerometer example Granularity of x, y, z and step counts Allows our research to be more innovative and cutting edge Timestamp: 1 sample per ~1 second vs. standard actigraph 1 sample per minute For example: 18,251 observations over 6 days for this user Graphing observations from one day:

20 mphenomic Biometric Data Collection Platform

21 4. Monitoring Treatment Fidelity: Neonate Therapy PI: Barbara Medoff-Cooper, PhD Title: Feasibility of Mindfulness Meditation for stress reduction in mothers of infants with complex congenital heart disease Funding: CHOP cardiac center research fund

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23 Patient App Dashboard View all surveys Raise non-emergency concern to provider Can be saved to REDcap Take a picture Saved to REDCap FAQ can include unique study instructions

24 Multi-Factor & REDCap-Integrated Authentication 1. Only Users with a REDCap Record set to Active can sign up 2. Patient asked to enter a securely generated token 3. Providers have access to confirmation token

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44 Service structure Meet with project manager (Mauricio Novelo) to discuss scope, feasibility and timeline Most R01-level projects are estimated to cost $15,000-25,000 depending on complexity Pilot projects using the existing platform can be performed at substantially reduced costs or no cost (e.g., a pilot study of 10 subjects) Priority is to support federally funded protocols and Penn-CHOP collaborations.

45 Conclusion Significant opportunities exist for the integration of mobile apps into clinical research Challenges include HIPAA compliance, FDA oversight and EMR data integration Newly introduced research platforms offer potential Growing number of mhealth services can assist with development

46 Appendix

47 Encouraging Participatory Research 1) Provide information about the research study to a diverse group of potential participants 2) Improve the informed consent process: electronic copy, study schedule 3) Improve communication between the research team and the study participant 4) Provide feedback about the study (e.g., participants evaluations)

48 Data Security Apps that are used in medical research must be HIPAA compliant if they have protected health information (PHI) Commonly used data elements that are PHI: Dates, addresses (often used for login). For an app to be HIPAA compliant, it must provide: Unique user authentication Encryption of data Mobile data wipe and data backup options in case device lost/stolen Routine data audit protocols De-identified data (no PHI) does not require HIPAA compliance

49 Monitoring Treatment Fidelity