ITMAT/CHPS mHealth Service

Introduction

Mauricio NoveloProject director, mHealth mobile device program, ITMAT/CHPS

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

Mobile Device Research an NIH Priority

NIH Study Section Feedback

mHealth Service: Support for NIH grant applications

Components of the mPhenomic platform1. ResearchAide: Logistics, Peer networks2. 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.

(Continued)

1. ResearchAide: Subject Recruitment and Logistics

2. Symptom Assessment: Neurosurgery Post-op Care exampleJared Pisapia, MD and Jayesh Thawani, MD

Mobile-optimized web app accessible from an internet browser, Android (left) or iOS (right)

Symptom Assessment: Research Staff Dashboard

3. Biometric data: Accelerometer example

• Granularity of x, y, z and step counts• Allows our research to be more innovative and cutting edge

• For example:

• 18,251 observations over 6 days for this user

• Graphing observations from one day:

Timestamp: 1 sample per ~1 second vs. standard actigraph 1 sample per minute

mPhenomic Biometric Data Collection Platform

4. Monitoring Treatment Fidelity: Neonate Therapy

PI: Barbara Medoff-Cooper, PhDTitle: “Feasibility of Mindfulness Meditation for stress reduction in mothers of infants with complex congenital heart disease”Funding: CHOP cardiac center research fund

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

Multi-Factor & REDCap-Integrated Authentication

2. Patient asked to enter a securely generated token

3. Providers have access to confirmation token

1. Only Users with a REDCap Record set to “Active” can sign up

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.

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

Appendix

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)

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, e-mail 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

Monitoring Treatment Fidelity