1. Creating a Contract with mHealth Resource (Internal & External)

2. Downloading the Insight App

3. Creating and Setting up a Participant

4. Phone up time and battery filter

5. Testing Insight App on the Phone

6. Submitting a Ticket

7. Creating and Assigning a Role

8. Creating CMS (Content Management System) Credentials

9. Adding a CMS (Content Management System) User to a Study

10. When a Research Member Leaves

11. Rules of Behavior

12. Project Change Request Form

Steps to create a contract with the TSET (Tobacco Settlement Endowment Trust) Health Promotion Research Center mHealth Resource

Each section provides an overview of the project process for applicants interested in working with mHealth. Internal is categorized as an individual who is employed through the University of Oklahoma Health Sciences Center (OUHSC) or University of Oklahoma (OU); all other organizations are designated External.

Select the correct tab as the Internal and External process varies.

Downloading the Insight App

To download Insight from the Google Play Store and continually receive updates, a participant must have a Google account (Gmail). Insight (or any app) cannot update without an active Google account on the phone.

Once a Gmail account has been created, follow the steps below to download Insight:

1. From the phone, Click on the Google Play Store app

   Open

   

2. In the “Search for app & games” search bar type: Insight mHealth Platform

   Open

   

3. Select Install > Insight will start downloading onto the phone

4. After Insight downloads, choose Open

   1. If installing on an Android 12+ device, see sections below “Location Permission on Android 12“ and “Volume and Vibrate Permissions on Android 12“

5. Click Allow to all permissions

   1. Allow Insight to make and manage phone calls?

   2. Allow Insight to take pictures and record video?

   3. Allow Insight to access this device’s location?

   4. Allow Insight to access photos and media on your device?

   5. Allow Insight to record audio?

   6. Allow display over other apps. (see below)

6. Android 12 additional Permissions

   1. For Sensor-related data collection, Android 12 (or higher) devices need permission to connect to nearby devices

   2.  

       

7. When the prompt “Let app always run in the background?” appears, select Allow

There are 2 variations of “Display over other Apps“ which can be displayed on different Android devices. One set of Android devices will only display the slider for the Insight app to enable the permission. The other variation will display the list of all installed Android apps that have permission to Draw-Over. In that case, the user must scroll down to select the Insight app, and enable the Draw-Over permission. Examples of each are shown below.

Location Permissions on Android 12

Android 12 had some additional Permissions functionality that affected the Insight app behavior and the integration of BlueTooth devices with the Insight app. In order for the Insight app to be able to connect to BlueTooth devices, the Locations permission must be set to “Precise“ or “Accurate“. Enabling the Permissions will be similar to the devices displayed here.

If the detailed Location Permission is not enabled when installing the Insight app or “Precise / Accurate“ Location is not enabled, the Android device will not be able to connect to BlueTooth devices.

CHANGING LOCATION PERMISSIONS

In order to revise “Precise or Approximate“ Permissions at a later time, the Location Services permissions must be accessed through Settings → Location → Locations Services. The pop-up display to select “Precise or Approximate“ will not be displayed again, even upon sequential re-install of the Insight application. Locations Services to enable BlueTooth connection using Location permissions are shown below.

Volume and Vibrate Permissions on Android 12

The Insight app for Android is also designed for specific functionality to notify Participants of Scheduled Events. Instead of using the Notifications bar (per the iOS / EDC version of the Insight platform) the Insight app uses Draw-Over and Notifications Volume and Vibrate to indicate that it is time for a Participant to complete a Scheduled Event. Changes to those Permissions for Android 12 are displayed here.

On this style of Android device, the Notification sound must be assigned and “Vibrate while ringing“ permission must be ENABLED.

THIS SETTING IS OFF BY DEFAULT ON SOME ANDROID 12 DEVICES, WHICH WILL PREVENT THE DEVICE FROM NOTIFYING A PARTICIPANT FOR A SCHEDULED EVENT.

For devices with Vibration and Haptic settings, it is important to verify that “Ring Vibration“ and “Notify Vibration“ are both enabled on the device. These settings MAY be DISABLED BY DEFAULT on the device, so it is important to check the settings when setting up the device.

Depending on the device, it is also important to verify that Vibration and “Vibrate for Notification“ are also enabled, such as shown below.

If you already have a Setup Code, follow the next steps. If not, go to the Creating and Setting Up a Participant section of this page.

Setting up Participant on the Insight App

1. In the Code field, enter the Setup Code > Select the Check button

2. Insight will configure the study > Once configuration is done, the participant is now set up on a phone

Creating and Setting Up a Participant

Once Insight is downloaded, there are three (3) methods to reference for setting up a participant on a phone.

Choose a desired method below:

• Method One: Participant Code Recommended

1. Go to the CMS login page “www.insightmhealth.com” and log in > Select Study

2. Click on the Participants tab (at the top of the CMS webpage) > Select Add New Participant button (at the top right corner)

3. Under the Info tab, enter a unique ID for the participant

4. From the Status drop down, select the Status of the participant: Active, Test, Completed, Archived

5. Select which Group the participant is in

6. Optional: Click PHI tab and enter protected health information (PHI must be enabled in Study Settings and enabled for a Role to enter or view participant’s PHI)

7. Click the Schedule tab

   1. Select the Time Zone for the Participant.

   4. Enter Wake and Sleep time for the Participant

   5. Default Sleep Schedule times are preset: Wake time is 7 am while Sleep time is 10pm.

   6. Optional: Changing Preferred time (Researcher decides if a Study will use this function). The default time is set for 6:00 PM regardless of function use.

8. Optional: Click the Settings tab to enter additional information

   1. Settings are dependent on what is enabled for the Study

9. Once finished adding all required information, the Create Participant button will be enabled > Click the Create Participant button (at bottom center of CMS webpage)

10. The participant is created > Find and Select the Participants tab > Search for the unique ID of the participant > Click on the participant

11. Find the participants Setup Code (at the top center of the CMS webpage)
    [Refer to the note at the end of Method 1]

    1. Make note of this Setup Code as it will be used to set the participant up on a phone.

12. At this point, Open Insight on the participants phone

13. In the Code field, enter the Setup Code from the CMS > Select the Check button

14. Insight will configure the study > Once configuration is done, the participant is now set up on a phone

• Method Two: Group Code

Prior to setting up the participant on a phone, you will first need the Group Code from the CMS.

Finding the Group Code:

1. Go to the CMS login page “www.insightmhealth.com” and log in > Select Study

2. Find and Select the Groups tab (at the top of the CMS webpage)

3. Click Open for the group the participant is envisioned for

4. The Group Setup Code is below the Group Name

   1. The Group Setup Code will be the same for every participant in a particular group.

Setting up a participant using Method Two (Group Code):

1. On the phone, open Insight

2. At the login screen, enter the Group Setup Code into the Code field > Select Check

3. Enter Wake and Sleep times for the week (Use the arrows on the top bar ( & ) to progress through the set up)

4. Once done inputting all needed information, click Continue

5. The participant is in the CMS under the next available numeric ID

6. Open CMS Insight > Select the Participants tab (at the top of the CMS webpage) > Select the newly created participant

7. To change the participant to a preferred ID, open the Information tab (to the left)

8. Optional: Add demographics

9. Click Save icon

• Method Three: Researcher Login

1. Open Insight

2. Click on Researcher Login (located below the blue Check button)

3. Enter login credentials: Username _____ , Password _____ > Select Log in button

4. Select the Study Name desired

5. Click Yes to confirm you selected the correct study

6. Click the sign at the top right corner

7. Choose the study Group > Enter a unique ID for the participant

8. Press the arrows ( & ) to the top right to navigate through the set up process

9. Enter the Wake and Sleep times for the week (To progress through the days, use the arrows ( & ) at the top of the screen)

10. Select Add Participant

11. Click Start Study

Phone up time and battery filter

A study site user can see the battery status and phone up time of a participant in the Insight CMS website. Phone up time shows how long the Insight app has been running in the background. This filter can be found in the Activity section under Participants tab. As shown in the figure, click More Filters to add or remove activities that are displayed on this page.

After that, click on the checkbox beside Phone up time and battery. Then, click on Refresh button to see the phone activity.

The following figure is an example of how the participant’s phone activity will show up after selecting the “Phone up time and battery” filter in the participant’s Activity section.

 Phone up time and battery status can show the PI why the participants are missing notifications for the study assessment. In order to receive the notification from Insight app, the app has to be running in the background all the time. Phone Uptime and Battery status are logged by the Insight app every 15 minutes if the app is running in the foreground or background. Sometime, the app can be forced-closed by the Android OS or the participant themselves. That can lead to missed notification issue for the participant.

Testing Insight App on the Phone

Once a research team member sets up a participant on the phone, they can test the study. The information below will discuss common techniques and recommendations for team members to utilize while testing their study.

If you have any questions, please submit a ticket through Service Desk and mHealth will address the issue there.

1. Open Insight

2. Swipe across the screen from far left to right > This will provide access to the “Staff Use Only” page

3. Select Login > Enter CMS login credentials (username;password)

4. A list of tabs will appear

   1. Ignore all except “View Assessment Schedule” and “Test Assessments”

      1. Clicking “View Assessment Schedule” will provide a list of all future scheduled assessments.

5. Select Test Assessments

   1. Utilizing the “Test Assessments” option allows a team member to test all the study’s assessments consecutively.

6. Select the desired Event to test

   1. The Event selected will appear as it does for a participant during the actual assessment; the phone will ring or vibrate (depending on the phones notification setting) and prompt the participant to take the assessment.

For the first (1^st) round of testing on Insight, it is recommended to do the following:

1. Check to verify the stages are progressing as expected

   1. This is important if stages are triggered off of calculated fields.

2. When going through assessments, look for the following technical items:

   1. Questions are presented and worded as expected

   2. Correct punctuation and spelling

   3. Correct measure scale for answers

      1. For example, if an answer choice is envisioned to scale from Strongly Agree to Strongly Disagree, verify it displays those choices instead of a typographical error like Strongly Agree to Strongly Agree.

3. Verify branching logic

   1. Start with the simplest answers as you will test the assessment path with the least amount of branching

      1. For instance, if a question states: “Did you take your medication today?” by answering “Yes” may lead the participant to the next question.

      2. However, answering “No” may branch to another question(s) inquiring why the participant did not take their medication.

   2. Start testing more complex branching logic individually

      1. Test the branching logic by answering a question differently to produce different scenarios.

      2. This allows the Tester to verify no questions are branching accidentally or incorrectly.

4. Confirm each group is receiving the correct Assessments and Events as assigned

5. If using Call Button(s), confirm the button is connecting to the correct person or place.

Testing using a “live” participant:

In this phase, you will create a test participant to receive assessments as an actual participant in the study would receive them. This allows you to verify assessments are being prompted at the correct time and not during sleep time.

1. Test the scheduling of assessments to confirm all are being prompted when expected

   1. Assessment schedules are based on the assessment settings.

   2. To view when current or future Assessments will be notified for your test participant, researchers are able to use the “Staff Use Only” page > then Select “View Assessment Schedule”

      1. Swipe across the screen from far left to right to access the “Staff Use Only” page

      2. Active participants will not have access to this feature; only Testers with CMS (Content Management System) login credentials.

2. Test having the phone launch Insight in different scenarios

   1. When the Insight app is closed

   2. When the Insight app is open

   3. Doing an activity that is extensive, such as, watching a high resolution video

3. Check the data; confirm you are collecting accurate and all intended information

   1. To access a study’s data, Go to the CMS login page “www.insightmhealth.com” and log in > Select Study > Click Reports (at the top of the CMS webpage) > Select the CVS or Excel button under EMA Data > You will receive an email from “donotreply-insight@insightmhealth.com” when the report is generated

 4. Do Not Force Close the Insight App from the Recents Menu. Do Not Close All

Submitting a Ticket

Reporting a bug or other technical issue is completed through Service Desk by submitting a ticket.

If you have not been added to Service Desk, ask the Principal Investigator to submit a ticket on behalf of you. They will need to include the email of the individual that is being added to Service Desk. An update will be provided on the ticket when mHealth has added the person.

Once an individual has been added to the Service Desk, they will receive an email from “mHealth Service Desk” to set up an account.

Reference the Insight and Troubleshooting Wiki for common technical issues before submitting a ticket. If you cannot find the issue experienced, please submit a ticket.

If for any reason you forget your login information or where to submit a ticket, you can reference the original set up email or click this link.

Creating and Assigning a Role

If a Role with its envisioned permissions has not been created for a study, it is the Principal Investigator's responsibility to create and then assign the Role. A list of Roles in a study is found in the Permissions tab under Groups Rights.

The researcher will need to have a list of permissions associated with the role; although, permissions can be edited at any time.

Creating Role:

1. Go to the CMS login page “www.insightmhealth.com” and log in > Select Study

2. Select the Permissions tab (at the top of the webpage)

3. Select Group Rights > Click Add New Role button

4. New Role will appear > Select Open to display a hierarchy of permissions

   1.  Edit the “New Role” title by selecting the field and inputting a desired name.

5. Hierarchy of Permissions:

   1. View: Role is able to view checked tabs

   2. Edit: Role is able to make changes for a specific permission

   3. Delete: Role is able to delete item(s) in a study

   4. Admin: Role is able to view, edit, and delete the permission it is enabled for

      • A check mark indicates the permission is enabled.

        • From the example below, permission “Questions” is enabled on a View level; individuals assigned this role will be able to view but not edit or delete questions in the study.

           

6. Click Save when enabling permissions is completed

Assigning Role (New User): Research member has not been added to the Study.

1. Go to the CMS login page “www.insightmhealth.com” and log in > Select Study

2. Select the Permissions tab (at the top of the webpage) > Click Study Users

3. In the Search Username or Email field, input the individuals Insight CMS username > Select them from the search bar

4. Select the Role drop down > Click on the desired Role > Select Add to Study

   1. If a Role is not created, follow “Creating Role” instructions before attempting to assign the role.

5. New User will appear at the bottom of the list with its associated Role

Assigning Role (Current User): Current research member switching to a different Role.

1. Go to the CMS login page “www.insightmhealth.com” and log in > Select Study

2. Select the Permissions tab (at the top of the webpage) > Click Study Users

3. Find the desired Research member from the Study User list

4. Find and Select the Role drop down > choose the envisioned Role

   1. If a Role is not created, follow “Creating Role” instructions before attempting to assign the role.

5. Select Save

6. The User is assigned the new Role

Creating CMS (Content Management System) Credentials

To request a new CMS user be created, please submit a ticket through the Service Desk; include the individual’s email address where the creation invitation will be sent. Once an invitation is received follow the instructions below:

1. An email invitation is sent from the email address 'donotreply-insight@insightmhealth.com” with the heading ‘Insight App’ and subject line of ‘Confirm Email’ > Click on Link

2. A new window opens to the below screen > Input the desired username and password into the designated field

3. Ensure the password chosen follow the requirements on screen; if the requirements are not followed, ‘Invalid password format’ and ‘Password do not match’ appear in red

Creating Credentials not Following Requirements

4. Once all requirements are satisfied, the red messages disappear > Select Submit to create the login credentials

Creating Credentials Following Requirements

5. A new window opens to the Insight login homepage > Input newly created credentials into the designated fields and click Login

6. The Two-Factor Authentication webpage appears > a One Time Verification Code is sent to the same email

Two Factor Authentication Screen

7. Email from ‘donotreply-insightmhealth.com’ sends the One Time Verification Code > Open the email to reveal the code

8. Navigate back to the Two Factor Authentication webpage > Input the one (1) use code and password into the respected fields > Click Verify to login

9. If the user is not added to any study, the screen will appear blank until a PI (Principal Investigator) adds the research member. Once added, the study will appear on screen; login again to verify study access.

CMS User not Added to a Study (blank screen)

Adding a CMS (Content Management System) User to a Study

Adding a new Research Member to a study is the responsibility of the Principal Investigator; this is executed through the Insight CMS (Content Management System).

The Principal Investigator needs the individual’s CMS username to input into the Search bar.

1. Go to the CMS login page “www.insightmhealth.com” and log in > Select Study

2. Select the Permissions tab (at the top of the webpage) > Click Study Users

3. In the Search Username or Email field, input the individuals Insight CMS username > Select them from the search bar

4. Select the Role drop-down > Click on the desired Role > Select Add to Study

5. The newly added User will appear at the bottom of the Study Users list

Have the individual verify they were added to the correct Study with the accurate Role by logging into Insight.

When a Research Member Leaves

Notifying mHealth when a research team members is crucial for maintaining protocol.

Once mHealth is advised of which individual(s) and Study(s), the previous User’s CMS account is archived. Archiving an account indicates the User will not have access to the Insight CMS; they are not able to login with their previous username or reset their password.

Rules of Behavior

Rules of Behavior describe security controls associated with user understanding of Insight data and security protocols as well as responsibilities and certain expectations of behavior for the following security policies, standards, and procedures. The Insight Platform used to create web and mobile applications is for Individuals who are authorized to use the University of Oklahoma Health Sciences Center (OUHSC) Insight Platform must comply with the specific Rules of Behaviors (RoB) listed below.

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Project Change Request

If a study request is determined by mHealth to be a Change Request instead of maintenance to an existing feature, research teams will fill out the Change Request Form provided below.

Submit the completed form to mHealth for review through Service Desk; it is mHealth's discretion to determine the possible timeframe of the requested change to mHealth Insight, Outsight, or Content Management System (CMS).

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