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We’re piloting MyCap within the context of OCTRI’s Biomedical Innovation Program Mobile Apps for Clinical Studies (MACS) program. For the MACS program, OCTRI is interested in soliciting projects that will use MyCap to collect patient-reported outcomes directly from participants either as a stand-alone project or as a companion to an existing REDCap-based study. We are seeking projects at all levels of complexity and will evaluate proposals for feasibility, starting with less complex projects and more complex projects later as we build capacity and knowledge. Link to the MyCap application: https://octri.ohsu.edu/redcap/surveys/?s=XAD7LYC8TC

What is MyCap

MyCap is a companion mobile application designed to capture participant/patient reported outcomes for individual REDCap projects via the participant's mobile device. Visit Project MyCap for more information, including demos.

Project personnel use the MyCap external module to connect their REDCap project to the MyCap mobile app, determine who they will be collecting from and define what data will be collected from the through the app. Participants download the MyCap mobile app from Google Play or the Apple App store, and then get a QR code from the project team to connect their app with the project's data collection activities.

MyCap Demo

Project MyCap - Scroll down to the bottom of the page

Known Limitations & Dependencies

  • Only Classic type projects are supported.

    • Longitudinal type projects are not currently support.

    • If you have an existing longitudinal project, we recommended you create a companion Classic project for MyCap.

  • The REDCap Team will add the mycap_super_api usr to your project and assign API permissions and API tokens for your project.
    • Do not remove this user or adjust this user's permissions.
  • Every participant will need to have their own device (i.e. phone or tablet) to complete surveys.
  • Participants will need a QR code in order to connect MyCap mobile app to your project.
    • Distributing the QR code is not automated by REDCap or the MyCap external module.
    • The project team will need to distribute the QR code on their own.
  • MyCap can only be set up during development phase of the project.
  • Once a project is moved to production to collect real data, the MyCap app cannot be modified to add new data collection activities.

Participant Support

Similar to survey projects, the REDCap Team does not provide support for a project's MyCap participants, including technical support and trouble shooting for the participant's device. We'll cover some considerations and best practices in the Ongoing Help and Support section.

Security Features

  • Participant data is stored locally on the device in an AES-256+SHA2 encrypted database.
    • Data remains on the device if an internet connection is not available.
    • Applies to both iOS and Android devices.
  • When an internet connection is available, data is transmitted directly to REDCap using a SSL (TLS v1.2) connection.
    • A hash-based message authentication code (HMAC) is used to verify the integrity of the data and to authenticate the sender.
  • Participant entered data (i.e. task responses) are not stored or sent anywhere else.
    • Data exists on the participant's device or on your server.
  • Data is wiped from the device after the MyCap app verifies that data has been successfully transmitted.
    • Note that there is an optional MyCap feature that lets a participant see some of the data s/he has entered for an individual task/instrument/survey. By default, data is wiped.
  • Participants create a 6-digit PIN that is used to open the app.
    • A participant can disable the PIN feature.
    • If a participant forgets their passcode then they would need to delete MyCap, re-install, and re-scan the QR code. The participant will be able to pick up where they left off.

Technology

MyCap leverages REDCap, ResearchKit, and ResearchStack to capture participant/patient reported outcomes via mobile devices. ResearchKit (for Apple devices) and ResearchStack (for Android devices) are open source frameworks developers can use to create mobile apps, like MyCap, for collecting health related research.

REDCap is used to define tasks/instruments/surveys to be completed by participants. MyCap translates REDCap task metadata into a structure compatible with ResearchKit and ResearchStack. When a project participant completes a task, MyCap converts the results into a format compatible with REDCap before synchronizing back to the REDCap project.



Request MyCap External Module

Project Set Up Best Practices

First Form

  • The first form in your project is used for storing MyCap participant information and some MyCap configuration information.
  • The MyCap external module adds fields to the first form for this purpose.
    • You can find a list of these fields in MyCap external module > Help > Annotations > Participant Instruments.
  • We recommend the first instrument be an empty form with just the record id, named, Participants or Participant Info.

Record ID

Best Practice: We recommend auto-numbering be enabled for the unique record id.

Request Process

Contact the REDCap Team to request MyCap.

Once MyCap is enabled for project find a link in the Project left nav > external modules


Set Up Considerations & Requirements

User Rights 

Users will need Project Setup and Design permission to use the the MyCap external module to set up and configure the MyCap mobile app for their project.

Best Practice: We recommend restricting Project Set up and Design permission to personnel setting up and managing the MyCap app.

Custom Record Label

Best Practice: We recommend you set up a custom record with the participant's first and last name to make it easier to track your MyCap participants in your REDCap project. Set up a custom record label via REDCap Project > Project Setup tab > Enable optional modules and customizations > Additional customizations > Set a custom record label.

Set Up Activities

All set up activities are organized in the external module in the Configure App section.

The main configuration activities involve:

  • Setting up the date for initiating data collection in the app.
    • All tasks are scheduled relative to this date.
  • Creating task(s) and defining when and how a task appears in the mobile app.
    • A task is a repeating REDCap instrument that will appear in the mobile app for data collection.
  • Customizing the mobile app for your project.
  • Publishing the app.
  • Adding participants.
  • Testing the app.

Set Up Help

The MyCap external module is well documented and includes help on every page, accessible by the (question) icon at the top right of each page, in addition to a HELP section.

This page is intended to supplement the documentation provided in the external module, by making recommendations, promoting best practices, and reviewing OCTRI's model of support.

Please plan on spending time reviewing the documentation in external module.

Download MyCap App for Testing

To test your project, you and other members or your study team will need to download the MyCap app to mobile device(s) you have access to.

Best Practice: We highly recommend you test your MyCap app on various Apple and Android devices.

Requirements & Dependencies 

The MyCap external module will add the following 6 fields to the first form in your project. All fields will have a MyCap action tag, that begins with "MC-". These fields are required to connect your MyCap participants and MyCap Settings to your REDCap project. Do not modify or delete these fields.

Find a list of these fields in MyCap external module in Help > Participant Instrument.


Set Up the Date for Initiating Data Collection in MyCap App

MyCap external module section: Configure App > Setup.

The MyCap app will need to track a date to start prompting the participant to enter data. Think of this as a start date and all data collection activities in the app, i.e. tasks, will be scheduled relative to this date. 

  • Click the Configure App > Setup.
  • Select One of the following fields
    • Install Date
      • This is the date the participant scans the QR code to connect MyCap on their mobile device to your project.
      • This date is automatically captured by MyCap and saved with the participant name in the MyCap External Module in the Participant  section and stored in the _installdate field in your REDCap project
    • Baseline Date
      • This date can be entered in REDCap by a user on the project prior to the participant scanning the QR code OR entered by the participant through completing a one-time task in MyCap.
      • If a baseline date has not been entered before participant scans the QR code, the participant will see a one-time task that prompting them to enter a date.
      • This date is saved with the participant name in the MyCap External Module in the Participant section and stored in the _joindate field in your REDCap project.


Create Tasks & Configure When and How Tasks Appear MyCap App

MyCap external module section: Configure App > Tacks

A task is a repeating REDCap data collection instrument that the study team configures to determine when and how it will be triggered in the mobile app for the participant to enter data. The MyCap External Module refers to a data collection instrument enabled as a MyCap task, as a Task Instrument or Task Form.

Creating a task is a two part process: 1) Build out a Task Form in the the Online Designer, and 2) Configure the Task Form to be a task and determine how it will appear in the mobile app and what will trigger the prompt the participant to enter data.

All tasks need to be added and tested while the REDCap project is in development. New tasks cannot be added after the project has been moved to production.

Best Practice: We recommend creating a one time task for the participant to confirm their identity. This is  because the study team has to manually distribute the QR code to the participant to connect the participant with your project, via capturing a screen shot of the QR code and then distributing it to the participant. This introduces a higher chance of error, as in sending the wrong QR code to the participant.

Three Ways to Create a Task

  • Add a new task and build a corresponding instrument
  • Enable an existing instrument as a task.
  • Add an active task.
    • Predefined tasks.
    • All required fields are created automatically.
    • Do not modify the fields using REDCap's Online Designer.
    • Not all active tasks are supported by both Android and Apple devices.
    • Find more information about active tasks in  MyCap external module > Help > Active Tasks

Known Limitations & Dependencies

Not all field types and field/form functionality are supported in the MyCap App.

The following is a list of supported field types and features:

  • Text Box (Short Text, Number, Date/Time, …) with date, email, integer, number, phone, time, and zip code validation.
  • Notes Box (Paragraph Text)
  • Multiple choice (single answer)
  • Checkbox (multiple answers)
  • Yes - no
  • True - false
  • File upload (The file upload field is used to capture images and video).
  • Slider / Visual Analog Scale (You cannot upload ad-hoc files that exist on the device's filesystem).
  • Branching Logic
  • Action Tags

MyCap Configuration Fields

The MyCap external module adds the 7 fields to every task instrument. 

  • All fields will have a MyCap action tag, that begins with "MC-".
  • These fields are required to collect data in the MyCap app for the task.
  • Do not modify or delete these fields.
  • Find a list of these fields in the MyCap external module, in Help > Task Instrument. 

Add a New Task

  • Click on Configure App > Tasks > New button
  • Enter the name of the task and click create
    • This creates a corresponding new repeating instrument and automatically adds the MyCap configuration fields to the form.
    • You are prompted to determine various settings that will define how and when the task appears in the mobile app.
      • For help determining Task settings, click on the (question) at the page top right.
      • All settings are documented in detail.
    • Task Section = how the task appears
      • Questionnaire" is the the recommended Task format.
        • Each question appears on its own screen.
        • Branching logic is supported.  
      • To enable the instrument as a task, click the SAVE button
    • Schedule Sections = when the task appears in the mobile app
      • To save your scheduling preferences, click the SAVE button 
    • Click the Online Designer button.
    • Add fields to the instrument before or above the MyCap App Fields - Do Not Modify section header.

Enable an Existing Instrument as a Task

All the instrument/forms in your project, except the the first form, are listed in Configure App > Tasks.

  • Configure App > Tasks
  • In table of Task Instruments, click on the pencil icon, under the Actions column, that corresponds to the instrument.
  • The MyCap module prompts you to fix issues with the instrument.
    • This means that MyCap module needs to add the 7 configuration fields to the instrument and enables the instrumentt to be repeating.
    • Click the FIX button.
  • You are prompted to determine various settings that will define how and when the task appears in the mobile app.
    • For help determining Task settings, click on the (question) at the page top right.
    • All settings are documented in detail.
  • Task Section = how the task appears
    • Questionnaire" is the the recommended Task format.
      • Each question appears on its own screen.
      • Branching logic is supported.  
    • To enable the instrument as a task, click the SAVE button
  • Schedule Sections = when the task appears in the mobile app
    • To save your scheduling preferences, click the SAVE button.

Add an Active Task

We do not recommend using Active tasks given the limited support across devices. 

MyCap leverages ResearchKit (for Apple devices) and ResearchStack (for Android devices) to capture participant/patient reported outcomes via mobile devices. ResearchKit includes a library of predefined tasks, or active task, that can be incorporated into a MyCap project. ResearchStack only supports one of these active tasks, Tapping Speed.

Find more information about Active Task in the MyCap external module, in Help > Active Tasks.


Customize MyCap App for Your Study

MyCap external module section: Configure App 

The following activities focus primarily on communicating important information about your study to your participants.

  • About Your Study Page
    • Click the Configure App > About link.
    • The "about" pages are the first thing displayed in the mobile app after a participant scans his/her QR code.
    • Edit the default page with the title of your study and a short description of the data being collected in the MyCap mobile app
    • You can add your own photo or logo.
    • You can add additional pages for to provide more information about your study.
    • Click Preview button to see how the about page(s) will be rendered in the mobile app.
  • Study Contact(s)
    • Click the Configure App > Contacts link.
    • When the participant clicks on GET SUPPORT in the mobile app, the contact information will be displayed.
    • Add at least one contact record, with information about how participant's can get help from your study team.
    • Click Preview button to see how the contact info will be rendered in the mobile app.
  • Study and App Links
    • Click Configure App > Links
    • Links appear in the MyCap app's menu underneath the "About" list item.
    • Links are optional.
    • Links can be configured to include your MyCap project code and participant code.
      • An example of a link using these codes would be a dashboard specific to your project or to a participant in your project.
  • App Color Scheme
    • Click the Configure App > Theme link.
    • Select a color scheme or define your own.

Publish Your MyCap App

MyCap external module section: Configure App  > Publish

You'll need to first publish your app so you can test it as a participant.

Any changes you make to MyCap configuration or the task forms are not automatically pushed to the MyCap app. You will need to publish to publish a new version for the changes to take effect.


Add Participants

MyCap external module section: Participants

For each participant in the MyCap external module, there is a corresponding record in your REDCap project.

There are two ways to add participants.

  1. Add records directly to your REDCap project.
  2. Add participants to the MyCap external module.
  • Per REDCap operations and requirements, do not add real participants to your MyCap project, until your REDCap project is moved to Production.
  • During development, test  the app, by adding "fake" participants, typically other study personnel.

QR Code

The MyCap external module will generate a unique QR code for each participant. The QR code connects the participant to your project via following 3 pieces of information.

  • The REDCap instance, as in OHSU's REDCap.
  • Your REDCap project ID. 
  • The participant's REDCap record id.

Add Records to Your REDCap Project

  • Manually create a record one at a time.
    • If you've set up MyCap using the Baseline Date, you can enter the baseline date for the participant at record creation or go back an enter the baseline date later
  • Import multiple records
    • If you import new records, do no import data into the the fields created by the MyCap External module.
      • You can find a list of these fields in MyCap external module > Help > Annotations > Participant Instruments.
  • Edit the participant in the MyCap external module to generate the Participant QR code.

Add Participants to MyCap external Module

  • Click on Participants
  • Enter the participant's first and last name.
    • Participants are entered one at a time.
    • If If you've set up MyCap using the Baseline Date, you'll need to enter the Baseline Date in the participant's corresponding REDCap record.
  • The participant's QR code will be automatically generated.
    • The MyCap does not have a mechanism to distribute the QR codes to the participants.


Distribute MyCap App to Participants

Move your project to production to collect real data in your project via the MyCap mobile app

Request to Move Your Project to Production

  • In addition to normal REDCap production activities/operations, ensure that you've published any changes you've made to your MyCap configuration or Task Instruments while testing.
    • New tasks cannot be added to you MyCap project, once your REDCap project is moved to production.
  • MyCap configuration, tasks, and setup will persist when the project is moved to production.
  • All the participants will be deleted when the when the project is moved to production.

Distribute MyCap App to Participants

There are three key activities the study team will need to manage for setting up their participants to use the MyCap mobile app for their project

  • Adding real study participants to the project following the steps outlined above.
  • Instructing participants how to download the MyCap app to their device.
    • Each participants will need their own device.
      • For Apple devices download from Apple App store.
      • For Android devices, download from Google Play.
    • Participants in the same project cannot share a device.
    • Multi-participant support on a single device is not supported.
  • Distributing to each participant their unique QR code.

Downloading the App

Best Practice: Arrange for the participants to download the app during an enrollment visit, either in person or over video conferencing, so the study team can help resolve any issues the participant encounters downloading the app and can ensure the MyCap app has been installed.

For remote instruction, the best practice would be to send participants a link to a survey, the content of which consisted of instructions about how to download the app for the different devices, using screenshots and/or embedding a video. Participants would submit the survey to confirm they had successfully downloaded the app.

Distributing the QR Code

There is no mechanism in REDCap or the MyCap external module to send each participant their unique QR code.

  • Study teams will need to determine how to distribute the QR code to each individual participant.
  • The participant will need to use the MyCap app to scan the QR code.
  • Scanning the the QR code into the MyCap automatically connects the participant to your project.
  • Participants will be prompted to enter data depending on how you've configured when your tasks appear in the app, relative to install or baseline date.

Best Practice: In the MyCap external module, capture a screen shot of the QR code. Outside of REDCap email the QR to to each participant, one at a time.


Communicating with Participants through MyCap

Announcements

Use announcements to send a message to all of your participants

Messages

Send personal messages to individual participants via Participants > Participant Table > Message Icon.

  • If the participant has enable push notifications for MyCap, they will receive a notification that they have a secure message.
  • If the participant has not enabled push notifications.

Collecting Data through the MyCap App

Once a participant has successfully connected the MyCap mobile on their device to your REDCap project, the mobile app shows the participant a list of tasks that the participant needs to complete for any given date.

  • Each task is represented by a card.
    • When a participant taps a card the task begins.
  • When a task is completed a result is stored in an encrypted database on the participant's device.
    • If the participant has an active internet connection the result will be synchronized to REDCap.
    • If the participant does not have an active internet connection, the result is stored in a queue.
  • Every time a participant completes a task all results in the queue will attempt to synchronize.

Push Notifications to Participant to Complete Tasks

The participant will only receive notifications if the have enabled push notifications for MyCap.

Task TypePush Notification
One timeNone
InfiniteNone
Repeating8:00 AM on the due/scheduled date
Fixed8:00 AM on the due/scheduled date

Tracking Data Collected in the App

The data collected in the MyCap mobile is stored in the the participant's REDCap record in the corresponding instrument task. You can track data collection via reports, the record status dashboard, and/or examining the participant's record.

Synchronization Issues

A synchronization issue is created when the Android or iOS MyCap app sends a task result to the REDCap server that is incompatible with your REDCap project for some reason. This typically occurs when a participant completes an old version of a task/instrument.


Production Changes


New tasks cannot be added after a project is moved to production.





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