RKStudio™ RKStudio™
Frequently Asked Questions

General

No programming or database experience is needed to use RKStudio. The point and click study builder within RKStudio is all you need to create your studies and surveys.

Participants complete surveys, active tasks, and manage device data directly on the mobile (iOS and Android) MyDataHelps app. In addition, participants can use the web to complete surveys, although active tasks (e.g., two finger tapping, memory test) and electronic consent functionality are not currently supported on the web.

Participants find it more convenient to complete surveys on their phone compared to the traditional research method of scheduling and completing a phone call with a study administrator or visiting a clinic. Additionally, participants can be reminded periodically via a push notification to complete any outstanding surveys. You may nudge participants by sending targeted messages to only those that meet certain criteria.

Yes, you can continually update survey instruments, modify schedules, and deliver tasks during the course of a study.


Data Security, Legal and Compliance

We have designed our platform–and the security program around it–to comply with the security and privacy controls defined by NIST 800-53 Rev. 4 at the FISMA Moderate baseline. We regularly undergo external formal assessments by a FedRAMP-accredited Third Party Assessment Organization (3PAO). Based in part on these formal assessments, our platform has been granted an Authorization to Operate (ATO) by the National Institutes of Health (NIH). We strive to protect the privacy of the Personal Information we collect and hold but we cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of data at any time.

The RKStudio platform (including MyDataHelps) is built on top of the CareEvolution HIEBus platform, which has been securely handling protected health information (PHI) for over 15 years for hospitals, insurance companies, and other organizations. HIEBus is HIPAA compliant and Meaningful Use Certified. Role-based access control ensures that participant data is only exposed to individuals with the appropriate permissions.


Account and Billing

You may currently create a free account and utilize all RKStudio functionality to send your study to up to 100 participants. There is no time limit in using the free version of the product.

If you plan to utilize the same surveys and instruments as an existing organization you can request that organization administrator add you as a user, after you register and create your individual RKStudio account. You will then be able to create a new study within the existing organization and utilize the surveys and settings already created. If you intend to create a different study with a different set of surveys, you will need to create a second organization.


Consent Forms and Electronic Signatures

Before joining a study in the MyDataHelps app, participants are prompted to complete the electronic consent form and provide their electronic signature.

While each IRB may vary in their policies and procedures, we have worked with several research institutions that allow electronic consents. Many of these institutions have found that the electronic consent process is much more efficient than traditional print, sign, and scan processes.


Survey Question and Answer Types

Currently, RKStudio surveys include but are not limited to the following question or step types: instruction, question, form (multiple questions within one step), image capture, video capture, completion step, and countdown step. For a full list of current steps/questions, please create a free account and view the “Surveys” tab and explore the “Step” types in the right bar.

Supported answers include but are not limited to yes/no, numeric (integer and decimal), free text, continuous scale, discrete scale, complete scale, height, weight, date, time of day, and value picker. For a full list of current answer types, please create a free account and view the “Surveys” tab and explore the “Answer Format” types in the right bar. If you do not see what you are looking for, please contact us as we are continually adding new functionality.

You may create customizable HTML-based web view steps in RKStudio. As an example, a “digital body map” was created to serve as a self-report measure that accurately assesses for the distribution of pain. Javascript can be utilized to create highly interactive and sophisticated survey steps.

Yes, you can create conditional/branching logic for every step within a survey to ensure participants only complete the applicable steps.

We currently support the majority of Apple’s ResearchKit active tasks. We are continuously updating our library as additional active tasks become available.


Additional Features and Functionality

No training is required. The RKStudio point and click WYSIWYG survey designer makes it easy to create a survey within hours with no coding required. Additionally, we maintain a user guide to ensure you have the support you need to build your study.

Yes, this is possible utilizing our advanced rules engine. You may send push notifications, SMS/text, or emails to participants that match certain criteria including but not limited to recent activity (e.g. adherence, survey answers, enrollment, device usage, surgery date), clinical outcomes (e.g. labs, medications), and participant phenotypes (e.g. age, sex, date of birth).

You may set a schedule to deliver surveys to participants anchored on enrollment, participant event (such as surgery or discharge), or a specific date. You may choose to deliver a survey on a set frequency anchored on that date (e.g. deliver a survey every two days, starting one week after enrollment). Additionally, you may manually deliver surveys to participants.

Yes, you can set a custom date as a reference point to deliver surveys to participants.

MyDataHelps is able to collect data from the Apple Health, Google Fit, and Fitbit ecosystems, including the devices and 3rd party applications that are supported by these platforms. For example, with Apple Health this includes (but is not limited to) Apple Watch sensor data (heart rate, steps, etc.), blood pressure devices, scales, and sleep apps. With Fitbit it includes wearables and smart scales, including fine-grained intraday data thanks to our partnership with Fitbit.

Yes, but this functionality is only available for studies involving people with Parkinson’s disease or other movement disorders. Contact the RKStudio support team if you are interested collecting this data for your study.

Yes, participants can share location data with your study. This is currently available on iOS devices.

Yes, through MyDataHelps the participant can download their medical history data from supported systems that comply with the SMART on FHIR standards. Hundreds of providers across the United States currently support this standard, including major health systems like Cedars-Sinai, Cleveland Clinic, and Geisinger.

Yes, Medicare claims data is available under the CMS Blue Button 2.0 initiative, which includes four years of Medicare Part A, B and D data for 53 million Medicare beneficiaries. This data reveals a variety of information about a beneficiary’s health, including type of Medicare coverage, drug prescriptions, primary care treatment and cost. Blue Button 2.0 uses the HL7 FHIR standard for beneficiary data and the OAuth 2.0 standard for beneficiary authorization.

Yes. A study can be utilized by researchers from multiple sites and institutions.

Yes, we support the ability to import your existing surveys and data from REDCap.


Exporting Data

Data from your study can be easily exported into CSV and JSON format.

You can set up RKStudio to automatically export your incremental data on a daily, weekly, or monthly schedule.

Yes, this is possible by working with an RKStudio team support member. To ensure your have your data on demand, it is recommended that you set an automatic export frequency before going live with your study.

RKStudio allows you to set a daily, weekly, or monthly frequency to export your incremental study data.

Yes. In addition to or as an alternative to setting an automatic export frequency, you may set the RKStudio settings to export your data directly to an SFTP (SSH file transfer protocol) server site.