CTSI Annual Pilot Awards to Improve the Conduct of Research

An Open Proposal Opportunity

A Digital Clinical Research Center (dCRC) for Translation of Digital Health Interventions

Proposal Status: 

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)


Excellent idea ! Although, it would be interesting to know what kind of data/research you have to supporting the need that "researchers face high costs and difficulty in developing app ideas into prototypes, testing prototypes on real users, and validating the intervention" ? Having said that, from personal experience, friction has mainly been in identifying technically proficient collaborators to develop the applications/technology. It would be great if eventually dCRC assists with that aspect as well which is alluded to in the Plan of the proposed project. Lastly, I think it would be useful to ultimately consider incentivizing the user experience to motivate faster and lasting adaption.

Hi Deepak, the "i2i" (Idea to Impact) Translational Digital Health proposal (see below) is designed to address your 2 comments on the need for assisting UCSF Digital Health Innovators, including those you specified: 1. "identifying technically proficient collaborators to develop the applications/technology" 2. "incentivizing the user experience to motivate faster and lasting adaption" The Idea to Impact (i2i) proposal is aimed at fostering the formation of sound ideas and facilitating the development of them. Your input on ways to better support innovators in digital health at UCSF are greatly appreciated. AJS

Together with Jeff Jorgenson at ISU, we surveyed the UCSF community in August 2010. At that time, 49% of 537 respondents strongly agreed that they would be interested in using mobile programming and consulting services if they were offered at UCSF. The free-form comments expressed needs for developing, testing, and validating apps. As part of my work in Open mHealth, I also hear about these needs from academia and industry alike, although that is anecdotal. Please see the i2i open proposal for other UCSF activities we propose fo helping with the need to find technically proficient collaborators (http://accelerate.ucsf.edu/forums/improveresearch/idea/7053). We welcome your suggestions on that proposal too!

Regarding your last point about incentivizing the user experience, we are VERY interested in "gamifying" research participation as you describe in your Open Proposal idea, and would love to work together to create easily-adaptable modules that research studies (and the dCRC in general) could use to keep participants engaged.

Hello Ida, I'm really interested in being one of your charter projects for the dCRC. I have an industry partner and a clinical site ready to create a validation project for a HIPAA-compliant physician-to-physician communication app. The project would be an extension of an mHealth Research Grant application that I just submitted. Please email me off-line if you would like more details (shantzj@orthosurg.ucsf.edu). I think this is a great cross-organization idea.

Thanks for your interest -- if we get funded, we will certainly be looking for charter projects. We will issue a call to the UCSF community for appropriate projects when the time comes.

Ida also works with Rock Health, an incubator based in SF Chinatown who provides support to IT entrepreneurs. She referred a group who developed a smartphone app aimed at reducing complications after hip and knee replacement. Our proposal was an initial selection for RAP mobile health. We will use the integrated claims repository to track outcomes.

Thanks, Steve. Over time, we will work with CTSI's Patient Recruitment Service to build more connections and overlap between the dCRC cohort and UCSF patients, and through BMI to make it easier to access patient-specific data in IDR and elsewhere.

Ida. This sounds great. Ambitious in a good way. It would be good to know what's already happening at UCSF in developing these tools. One of the other proposals was to encourage the development of new apps and that could interface with yours I would guess. I'd also wonder if all the public discussion of confidentiality concerns with Google te al is being addressed in this. If Facebook is being used, does the potential participant/subject have to disclose disease-related information?

- I'll let Ida respond to the first part of the comment. - Regarding confidentiality concerns: This is a big deal for studies using online social network data, both in terms of perception and reality. Even when study data are NOT being shared with Facebook/Google/etc and study materials state this explicitly, we've received feedback from pilot studies that potential participants are really scared off by confidentiality concerns. We'll address this head on with our recruitment efforts with the intrepid support of the Participant Recruitment Service! Commercial entities are successful in overcoming this barrier, and so can we. There are also real concerns when it comes to sharing information about your own social network. For example, information about your Friends is inevitably shared with the research study without their explicit consent. We've worked out a good compromise with CHR for our pilot and an open collaboration with the CHR, and should be able to navigate these waters.

UCLA has a Mobile Web Framework which allows for quick deployment of apps that run on web browsers over cell phones. Individual projects are also developing some of these tools, but not in a reusable way across projects. Several of the other Open Proposals would certainly interface with this one. The dCRC would help to bring a degree of technical cohesion across these projects as they are deployed across UCSF, and would also provide tools and expertise for validating these projects. The Open Proposal on research networking would not interface technically with the dCRC Facebook does not use OpenSocial while we propose to focus initially on support for collecting Facebook social network data.

Terrific idea and one in which CRS could potentially collaborate and expedite.

This is a great idea! Targeted social media networks and mHealth applications are effective and inexpensive ways to recruit patients and collect data. While the web is an effective means for collecting data, researchers find themselves off-site without internet access. 3G and 4G networks available through iphones and ipads provide an opportunity to collect information when internet access is not available. Unfortunately, the appearance of websites that have not been adapted for mobile devices can be difficult to use on these devices. Usable data collection/processing models on mobile devices will reduce research costs. Expanding access to and validating digital interventions will have a long term impact on research.

I have always been supportive of this effort as I think it is very far-sighted in its goals. Certainly the concept of Open mHealth providing re-usable tools is a very noble and egalitarian one. I think perhaps it has had too broad a scope to get the traction it deserves at UCSF. I really would like to see more UCSF investment in this area. I would think that a very focused pilot using these assets followed up by applying them to a strategic area within UCSF would be a worthy undertaking. This is an enterprise concept and finding support for such broad ideas seems very difficult. I'd like to hear how others overcame this hurdle.

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