Rationale: The confluence of online social media, smart phones, and sensor technology is giving rise to a tidal wave of digital health interventions that have vast potential for improving health at low cost. As with consumer software, digital interventions are more likely to be effective if user feedback and determination of effectiveness is sought early and often. At present, however, researchers face high costs and difficulty in developing app ideas into prototypes, testing prototypes on real users, and validating the intervention. These difficulties are a significant barrier to securing extramural funds, and to the translation of digital health technology into population health. The challenge the dCRC addresses is to reduce the expense, time, and expertise required to prototype and validate digital health interventions.

Plan: The long-term goal of the dCRC is to support the full range of digital health intervention research, from early prototype development to pilots to large scale RCTs. In this first year, we will focus on a large class of projects that we are seeing in CS, BMI, and CRC: projects that want to 1) collect and analyze sensor-derived actigraphy and geolocation data, and 2) leverage online social networks (from Facebook, in particular) for recruitment and for delivery of novel network-related interventions. These project needs require new methods for data collection, analysis, visualization and feedback to patients, and confront investigators with a variety of barriers (technical, design, ethical). It is inefficient for each team to pull together the multidisciplinary expertise needed to surmount these barriers. To meet this challenge, we propose to create a Digital Clinical Research Center (dCRC), housed within CRS in collaboration with BMI, CS, and ETR, that will support development and translation of novel digital health interventions by:

1. Providing re-usable software modules for data collection and analysis. Through a combination of UCSF-led development and access to open software from Open mHealth (Co-Founder Sim), we will provide researchers with standard modules for collection, analysis, and visualization of:
   • Actigraphy and geolocation data collected via smartphone and other sensor devices
   • Online social network data from Facebook.com collected via “Facebook Connect”. Modules will facilitate feedback/visualization of intra- and inter-network health comparisons. (Based on prior work by The Social Heart Study, PIs Pletcher and Fowler]).
   • An initial set of self-reported demographics and health-related behaviors including exercise, diet and sleep collected via mobile devices. Our efforts will align with and contribute to NIH’s PROMIS and PhenX projects, which aim to standardize clinical research data collection methods.
2. Recruit a standing dCRC cohort interested in digital health interventions. PRS will lead online recruitment of at least 2,000 broadly representative participants interested in testing new health technology and undergoing some or all of the measurements detailed above.
3. Develop CRC-type procedures for using the dCRC cohort. Using standard CRC’s as a model, we will develop an application, review process, protocol development support (via CS) and a recharge for UCSF and outside investigators (including industry) interested in using the dCRC cohort for early (pilot) and late stage (validation) testing of digital health interventions.
4. Develop ETR-type resources for commercializing validated digital health interventions. ETR will develop matchmaking, IP consultation and other resources to support academic investigators interested in licensing or otherwise commercializing their products.

The dCRC will drastically reduce the marginal costs and expertise required to translate good digital health intervention ideas into products that improve population health. This service is highly relevant to industrial interests, and we expect that revenue generated from allowing industrial access to the dCRC will eventually support core services and highly subsidize costs for UCSF and other academic investigators.

Criteria and Metrics of Success: 5000 participants recruited (500 by end of Year 1); 10 new re-usable data collection/processing modules, in addition to modules available through Open mHealth; 5 projects using dCRC modules in their technology; 2 projects using the dCRC cohort; a recharge mechanism and a dCRC application and review process in place.

Cost and justification: $40K in programming costs, $10K for recruitment, $50,000 for 0.5 staff FTE = $100,000 total. We expect initial recharged projects early in FY08, and self-sustainability within 3 years.

Collaborators: I. Sim (BMI, Open mHealth); M. Pletcher (CS); B. Balke, N. Nasser (CRS); J. Lee (ETR); J Fowler (UCSD); J. Olgin (UCSF Chief of Cardiology); and T. Parsnick (SF Coordinating Center)