Submitting a Grant?

Created by Chris Shaw (Unlicensed)
Last updated: Aug 31, 2021 by john Putzke

Increase your grant’s “Innovation” and “Approach” scores by including Studytrax as a proven data collection tool that provides the following benefits: 1)  engages and retains subjects through a dynamic portal, and 2) integrates the analytical/dissemination phase directly within the application (which also eliminates reporting headaches such as progress reports).

Get Started

Click here to schedule a call to tell us about the needs of your grant. We provide investigators with: 1) a support letter, 2) a budget proposal, and 3) descriptive text about Studytrax features and security for inclusion in the grant. Custom development may also be a part of some grants.

Support Letter

A Support Letter helps assure review committees that all parties are committed to the grant, understand the requirements, and have planned for success.

Generating A Quote

Studytrax will put together a quote covering the entire grant period. Contact Studytrax here to get started.

Grant Text: Studytrax Description

Insert into your grant where appropriate the text below describing Studytrax functionality and security. Contact Us if your needs are different, as we have a number of examples and considerable experience helping investigators with grant write-ups.

General Studytrax Descriptive

The purpose of the study database is to track subject enrollment, capture data elements in a series of short, well-designed forms all available on-line via a secure web portal, and facilitate the transfer of data into statistical packages for analysis. The database application, called Studytrax, uses MS SQL Server as the back end relational database. The program can support one or more research studies, is presently being used at dozens of major academic research centers to support numerous NIH funded projects and is available commercially ( http://www.studytrax.com/ ). The HIPAA privacy rules and HIPAA security rules mandate that covered entities have in place appropriate policies and procedures to protect the confidentiality and security of protected health information. In compliance with these regulations, the database security features of Studytrax target multiple levels including the data element (e.g., restricted access to fields), user (e.g., password authentication access), application (e.g., role-based access to features, access audit trails), and hosting services (e.g., firewall, secure sockets layer). Taken together, these features ensure access control, audit control, data integrity, user authentication, and transmission security. The research project(s) will be set up in Studytrax to ensure exported datasets are de-identified as defined in the HIPAA privacy regulation [45 C.F.R. §164.514 (b)(2)]. A 21 CFR Part 11 compliance document is available upon request from the creators of the software, a company called ScienceTRAX, LLC.

Subject Portal Innovation Text

Subject dropouts and incomplete self-report outcome measures are well documented, persistent problems in clinical research and patient registries (Bell et. al., 2014,  Mortz, 2001).  Estimates vary based on methodological and cohort-related characteristics.  However, dropout rates in the 10 – 30% range are common and increase with longer follow-ups (e.g., Moon et al, 2012).  Similarly, incomplete items on outcome measures can be as high as 50% (e.g., Ayilara et al., 2019) and vary based on questionnaire characteristics (e.g., number of items) and assessment domain (e.g., functional, physical, emotional. [Rosett et al., 2020]).  Advances in information technology offer exciting opportunities to directly address these problems. 

Historically, electronic data capture (EDC) systems have focused on accurate execution the research protocol and data storage.  As a result, participants interacting with these systems experience nothing more than the burden of data entry.   Leveraging principles from the Patient Health Engagement Model (PHE-model; Barello et al, 2015; Graffigna et al. 2016; Graffigna et al. 2017), Studytrax is an innovative EDC system with an internet-based portal that is designed to engage and retain subjects in the research process.  The core feature set includes the following:

  • Data Entry

    • Guided, self-paced data entry with flexible layout (e.g., phone, tablet, PC) and validation options.

  • Incentive Points

    • Participants earn points for completing forms which can be exchanged for gift cards.

  • Secure Communication

    • An integrated messaging system for participants to ask questions, transfer files or capture and send device camera images

  • Personalized Content

    • Dynamically generate educational materials or study, disease, recommendation, etc. information based on the participants own data (see Ali et al, 2020 for article on retention utility).

Taken together, these features bring the portal alive for participants, personalizes it, and give them a powerful, retention building “me-first” reason to return.

References 

Ali Z, Anderson K, Chiriac A, Andersen AD, Isberg AP, Moreno FG, Eiken A, Thomsen SF, Zibert JR.  High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports. PLoS One. 2020; 15(7): e0235500. doi: 10.1371/journal.pone.0235500

Ayilara OF, Zhang L, Tolulope TS, Olawale FA, Sawatzky R, Bohm E, Lix LM. Impact of missing data on bias and precision when estimating change in patient-reported outcomes from a clinical registry. Health Quality of Life Outcomes. 2019; 17(1):106. doi: 10.1186/s12955-019-1181-2

Barello S, Graffigna G, Vegni E, Savarese M, Lombardi F, Bosio AC. “Engage me in taking care of my heart”: a grounded theory study on patient-cardiologist relationship in the hospital management of heart failure. BMJ Open. 2015 5(3): e005582. doi: 10.1136/bmjopen-2014-005582

Bell ML, Fiero M, Horton NJ, Hsu CH. Handling missing data in RCTs; a review of the top medical journals. BMC Medical Research Methodology. 2014;14(1):118. doi: 10.1186/1471-2288-14-118

Graffigna G, Barello S, Bonanomi A. The role of Patient Health Engagement Model (PHE-model) in affecting patient activation and medication adherence: A structural equation model. PLoS One. 2017; 12(6): e017986. doi: 10.1371/journal.pone.0179865

Graffigna G, Barello S, Bonanomi A, Menichetti J. The Motivating Function of Healthcare Professional in eHealth and mHealth Interventions for Type 2 Diabetes Patients and the Mediating Role of Patient Engagement. Journal of Diabetes Research. 2016 : 2974521. doi: 10.1155/2016/2974521

Graffigna G, Barello S, Triberti S. Patient engagement: A consumer-centered model to innovate healthcare. Patient Engagement: A Consumer-Centered Model to Innovate Healthcare. 2016. 1–141.

Moon E, Chang JS, Kim MY, Seo MH, Cha B, Ha BH, Choi S, Cho HS, Park T, Ha K. Dropout rate and associated factors in patients with bipolar disorders. Journal of Affective Disorders. 2012; 141(1):47-54.  DOI: 10.1016/j.jad.2012.02.025

Mortz CG, Lauritsen JM, Bindslev-Jensen C, Andersen KE. Prevalence of atopic dermatitis, asthma, allergic rhinitis, and hand and contact dermatitis in adolescents. The Odense Adolescence Cohort Study on Atopic Diseases and Dermatitis. Br J Dermatol. 2001;144(3):523–32. DOI: 10.1046/j.1365-2133.2001.04078.x

Rosett HA, Locke SC, Wolf SP, Herring KW, Samsa GP, Troy JD, LeBlanc TW. An analysis of missing items in real-world electronic patient reported outcomes data: implications for clinical care.  Support Care Cancer. 2020; 28(11): 5099-5107. doi: 10.1007/s00520-020-05338-8

As Applicable, add ONE (i.e., “A”, “B”, or “C”) of the following recruitment options:

(A) Anonymous data collection only:

Participants will enroll themselves via an email or website containing a “Participate“ link/button. When clicked, forms without identifying fields will be presented for completion. To ensure information can NOT linked or tracked to participants, a meaningless ID will be automatically generated and data transferred via an encrypted connection.

(B) Anonymous, option to convert to named account:

Participants will enroll themselves via an email or website containing a “Participate“ link/button. When clicked, forms containing screening questions without identifying fields will be presented for completion. Upon save, an automated screening ID will be generated and data from the screening form will be transferred via an encrypted connection so as to ensure screening information can NOT be tracked back to participants.  Those that pass screening criteria will be asked for participation consent. Those choosing to give consent will have an option to create an account for the study web portal  which communicates with Studytrax servers using Restful web services over an encrypted Secure Sockets Layer (SSL).

(C) If only staff will create accounts:

Research staff will create and manage participants accounts for the study portal. Participants will validate their accounts and have control over their account information (e.g., password).  The study portal communicates with Studytrax servers using Restful web services over an encrypted Secure Sockets Layer (SSL)

As Applicable, add the text below for Reward Points:

The number of reward points earned for completing each form and/or study visit will be assigned in Studytrax. The study portal communicates with the Studytrax servers using Restful web services over an encrypted Secure Sockets Layer (SSL).  Participants exchange reward points for gift cards in the study portal using a Studytrax partner's Service (RaaS) Application Programming Interface (API). All communication with gift card partners is over SSL using HTTP Basic Authentication. All transactions involving reward points and gift cards are logged both in Studytrax and the gift card partner’s site.

Application Hosting and Security Description

Studytrax hosted solutions are fully HIPAA Compliant and ensure access control, audit control, data integrity, user authentication, and transmission security. Studytrax uses the data center services of Rackspace, a premier hosting company. Rackspace offers top of the line hosting facilities. As a summary of the Rackspace facilities: (1) Access to data center is secured by Biometric hand scanners and monitored 24×7 by closed circuit cameras. (2) Public access to data center is strictly forbidden. Only level three technicians are permitted in the data center. (3) HVAC [Heating Ventilation Air Conditioning] systems are used to completely circulate and filter all the air every 90 seconds. (4) Continuous UPS [Uninterrupted Power Supply] systems keep all servers up and running in the event of a total power outage. (5) Diesel engines are located on-site to provide power for extended power outages. (6) Enterprise-class routing equipment used in conjunction with multiple fiber carriers to ensure zero downtime due to network access.

Data is protected from loss by the following: (1) A redundant array of independent disk [RAID] Level 5 is used to ensure that data will not be lost if a hard drive fails, (2) full database backups are done nightly, (3) database log file backups are done every 15 minutes, (3) database integrity checks and index maintenance are performed nightly, (4) the database and log backup files are retained as part of Rackspace’s backup process and also transferred every hour to Microsoft’s Azure geographically redundant storage.

Data security is assured by the following: (1) All server requests are transmitted over SSL using 256-bit encryption, (2) a dedicated Cisco router firewall only allows requests to Studytrax, (3) the database is stored on a separate server in a private independent subnet with no public IP address, (4) database and log files are stored on encrypted disks, (5) servers are protected by AlertLogic intrusion detection and log monitoring tools, and (6) database and log backups are encrypted.