Request for Applications DIGIBIOMARKERS TECHNOLOGY AWARD Application Submission: November 12, 2018 Please note that you will be submitting through the Indiana CTSI s grants management software WebCAMP. The WebCAMP user s guide is available under the funding announcement here: https://www.indianactsi.org/funding/all-open-rfps/ 1
GENERAL INFORMATION INFORMATION FOR APPLICANTS A new innovative application platform, DigiBiomarkers, has been developed by Indiana Biosciences Research Institute (IBRI) in collaboration with MavenSphere, Inc., to facilitate the rapid deployment of tools based on Apple s ResearchKit, HealthKit, and CareKit software frameworks to capture digital information from individuals or patients. See announcement: https://www.indianactsi.org/news_/new-mobile-research-tool-rfa/ This software platform optimizes the secure data collection from patients during clinical trials or clinical practice and provides HIPPA compliant data analysis and reporting information for use by scientists for support of their research or clinicians and their treatment teams. The current platform uses iphone devices to collect date from: Survey instruments (e.g. pain, depression scale, quality of life) Tasks (e.g. spatial memory, gait & balance, reaction time) Environment captured with individual consent, but no individual interaction (e.g. activity, temperatures, mobility, data from HealthKit connected devices/apps fitbit, pulse, nutrition, and weight) The Indiana Clinical and Translational Sciences Institute (CTSI), conceived as a statewide laboratory to conduct innovative research and education in health sciences, is now offering access to this platform to assist in achieving its mission "to increase translational biomedical research and improve the health of the people of Indiana and beyond. Applications to this program are limited to a total of $10,000 for customization of the software. Duration of the project may vary, depending on the research needs. DIGIBIOMARKER INFORMATION DigiBiomarkers (www.digibiomarkers) enables a wealth of data to be captured from patients which has not been available up to this point in time, and brings more objectivity and efficiency to clinical trials, thus accelerating the pace of quality research. The opportunity to remotely and continuously monitor patients provides a more contextually valid picture of patient health, while increasing the number of data points researchers have from which to draw conclusions. DigiBiomarkers may also be updated to include any additional modules which may be required for a trial on a case by case basis (includes any new audio/video modules which might be required for a study. Specific details about the platform are linked on the RFA website and at the end of this document. Researchers considering an application for use of this platform should contact Bharath Bynagari of DigiBiomarkers to discuss their project and receive a demonstration of the application platform prior to submission. bynagari@mavensphere.com 317-590-8275 (p) 2
WHO MAY APPLY IUSM: All full-time faculty, regardless of tenure status, having a primary appointment within the School of Medicine as Assistant Professor or Assistant Scientist and above. This includes those faculty appointed as part-time Assistant Professor or above, if they are geographically full-time. Faculty at the IUSM regional centers for medical education are eligible to apply (assuming they meet all other eligibility criteria) and are considered IUSM faculty for purposes of identifying the sponsoring affiliate as described above. Faculty that hold the title of visiting rank must discuss eligibility with the CTSI and obtain approval. To discuss eligibility email icreate@iu.edu IBRI: All IBRI investigators eligible to receive funding according to the institution s central research office IUPUI/IUB: All tenured or tenure-track faculty at or above the Assistant Professor level regardless of tenure status, if approved to serve as a PI by the institution s central research office; faculty at all levels of the Scientist or Scholar tracks. Purdue: All tenured or tenure-track West Lafayette faculty at or above the Assistant Professor level; all research professors; all clinical faculty. Notre Dame: All tenured or tenure-track faculty; all research faculty; all special professional faculty. IU Health: Applicants must be employees of Indiana University Health at any IU Health system entity with medical staff privileges. Residents and fellows are not eligible for this mechanism. APPLICATION PROCESS Full applications are due on November 12, 2018. Submissions are via the Start a submission link found here: CTSI Digibiomarkers Link Researchers should contact Bharath Bynagari of DigiBiomarkers to discuss their project and receive a demonstration of the application platform prior to submission. bynagari@mavensphere.com 317-590-8275 (p) APPLICATIONS SEQUENCE 1. Face Page The face page specifies the title of the proposal, principal investigators and his/her affiliation, collaborator(s), affiliation, and where work will be performed. Department / School support must be indicated by completion of all appropriate signatures on the face page(s) FOR EACH PI/CO-PI. As submission will be electronic only, facsimile or electronic signatures are appropriate. Projects should have a start date no earlier than January 1, 2019 2. Abstract & Keywords The abstract should be a brief (300 word maximum) abstract in layman s terms. 3
Provide 5 keywords that describe the research content of your project No budget is required 3. Research Plan Research Plan should have at least 1/2 inch margins (top, bottom, left and right) and is NOT to exceed 3 single-spaced pages, excluding references. Font must be clear and readily legible and reasonable size. Use an Arial, Helvetica, Palatino Linotype or Georgia typeface, a black font color and a font size of 11 points or larger. Make every effort to write your research proposals toward a general scientific audience; avoid fieldspecific jargon and undefined abbreviations. The Research Plan narrative should be structured in accordance with the following format: A. Specific Aims and methods of the current proposal: Communicate the scientific significance and innovation of the proposed collaboration. Describe the specific aims of the proposal, the methods of procedure, and the rationale behind the chosen approach to the problem. Include a discussion of pitfalls that might be encountered and the limitations of the procedures proposed. B. Translational potential for the project: Describe the project s potential impact on human health and/or how may it be translated to impact human health concerns in the future. C. Use of funds for future extramural funding / IP: Describe how the collaboration will lead to an extramurally funded research application / program or generate IP. For extramural funding, specifically describe the agency, the program and time frame that you plan to submit an extramural proposal. D. Project timeline: The following (or similar) table should be completed and inserted at the end of the research plan. 4. References Cited 5. Biosketch: Biographical sketch (5-page maximum) of the principal investigators and coinvestigator/collaborator in the NEW September 2017 NIH format available at 4
https://grants.nih.gov/grants/forms/biosketch.htm. POST AWARD REQUIREMENTS All awards will be monitored for progress. Progress monitoring generally includes the following from all project PIs: o Semiannual progress reports due in January and July that report status of milestone progress along with documentations of external grant submissions/awards, IP, publications, and/or presentations arising from the supported research. o In addition, post award evaluation will consist of patient satisfaction surveys that will be embedded in the program and interviews / case studies with the awardees at the end of the project. o Annual follow-up reports will be requested up to 5 years after the project ends, including but not limited to the following data: External grant submissions and awards arising from the supported research Intellectual property arising from the supported research Publications arising from the supported research Additional impacts of the award on your research and the collaboration Grant recipients are required to acknowledge receipt of Indiana CTSI support in any presentation or publication of work funded by this award as follows: This project s collection of patient-centered data was facilitated by the DigiBiomarkers platform provided to researchers by the Indiana Biosciences Research Institute and MavenSphere Inc. This was funded by support from the Indiana Clinical and Translational Sciences Institute funded, in part by Grant Number UL1TR002529 from the National Institutes of Health, National Center for Advancing Translational Sciences, Clinical and Translational Sciences Award. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, Indiana Biosciences Research Institute, or MavenSphere, Inc. 5
ADDITIONAL DIGIOBIOMARKERS INFORMATION Survey Data DigiBiomarkers can incorporate any survey data which is usually captured using traditional penand-paper reports or diaries. Researchers are given complete control over how data is collected and choose their preferred format (Figure 1.) * Available answer formats: 1) Boolean answer format (Yes/No) 2) Date answer format 3) Email answer format 4) Image choice answer format 5) Location answer format 6) Numeric answer format (Can set maximum and minimum values) 7) Scale answer format (Horizontal or vertical) 8) Text answer format (limited or unlimited character text entry) 9) Text choice answer format (multiple or single text choice answer) 10) Time of day answer format 11) Value picker answer format 12) Year picker answer format *Additional formats are added upon request/as required Figure 1. Selection of answer formats in the DigiBiomarkers platform 6
Active Tasks Various cognition, motor and fitness tasks are available with DigiBiomarkers. Cognitive tasks may be altered to be more easy or difficult, depending on the study. Cognition tasks include: 1) Paced Serial Addition (PSAT) Test 2) Reaction Time 3) Spatial Memory 4) Stroop Test 5) Tower of Hanoi 6) Trail Making Motor activities include 1) Gait and balance 2) Knee Range of Motion 3) Shoulder Range of Motion 4) Tapping Speed Fitness Tasks Include 1) Fitness (user walks for specified duration and sensor data from accelerometer, device motion, pedometer, location and heart rate data are collected where available) 2) Timed walk (User is asked to walk a specific distance and results are collecting using accelerometer, device motion, pedometer and location of the user). Figure 2. Active task overview 1
Passive/Environmental Data DigiBiomarkers collects the following data continuously with user permission: 1) Geo location (GPS data based on latitude and longitude position) 2) Outside temperature and weather 3) Physical activity (Steps) 4) Data from HealthKit enables IOT devices, including Fitbits, glucometers, and more. Adding additional modules DigiBiomarkers enables the addition of new modules to the platform based on the needs of individual studies. For example, if a study has a particular audio track which must be played by participants, this may be added to DigiBiomarkers (Fig. 3). Figure 3. Individual modules and functions may be added to DigiBiomarkers as required. Patient Enrollment Each participant is assigned a randomization code and an 8-digit enrollment code. No PHI is collected by DigiBiomarkers. Once enrolled, participants access the app using a 4-digit access code or fingerprint data if enabled on the user s device (Figure 4). Figure 4. Patient enrollment using DigiBiomarkers 2
Timing DigiBiomarkers enables survey/active data to be collected at specific time points throughout a trial- be it pre-trial, trial or post-trial. Researchers may configure the frequency in which surveys and activities are to be completed by participants (daily, weekly, monthly etc.). Figure 5. Control when a participant engages through scheduling and push notifications Technology Presently, DigiBiomarkers is available on ios devices (ios 10 or greater required). Patients who do not wish to use iphones may interact with the study protocol through the patient- facing DigiBiomarkers web-app. There are no restrictions on the number of users a researcher may enroll. DigiBiomarkers is compliant with HIPPA regulations 3