REACTIVE R1 - Instructions for Use

Product Details

Overview

The REACTIVE application is a configuration of the PROTECT Digital Health Platform, a cloud-based standalone software product developed by the University of Exeter that delivers assessment, monitoring and management of brain health for users. The REACTIVE application is under investigation for use by adults aged 65 years and over on any personal computing device with an internet connection. The application assesses cognitive function and dementia risk in adults by detecting changes that may indicate early signs of cognitive impairment, dementia or neurological issues with the intention of providing an early warning system for clinically meaningful cognitive decline for adults living in the community. It is intended to be used as part of self-management of brain health and/or as part of the clinical assessment pathways into primary or secondary care. It is not intended as a standalone diagnostic tool.

Who is it for?

REACTIVE is under investigation for:

• Patient / public use for adults aged 65 years and over in a community setting to monitor changes in cognition over time as a means of identifying increased risk of dementia.
• Study partners over the age of 18 supporting patients by providing information on behalf of the patient.
• Senior administrators of the REACTIVE programme to set up support administrators.
• Support administrators of the REACTIVE programme to monitor user activity, support users with the application, and coordinate sharing REACTIVE outputs with clinicians and other stakeholders.
• Clinicians to support them in caring for patients using REACTIVE outputs in combination with other clinical assessments (to note clinicians will not have access to the app itself so are not described further in these instructions for use.)

REACTIVE is not under investigation for:

• Giving a clinical diagnosis.
• Use by patients under the age of 65.

Patients:

• Register with the application
• Complete cognitive assessments and questionnaires according to a defined schedule (every 6 months)
• Receive feedback on their cognitive performance following each round of cognitive assessments
  • If cognition is within the expected range, feedback will focus on their strongest cognitive domain.
  • If the patientʼs cognitive performance is below the expected range for their age or if a significant decline is detected that takes them out of the expected range compared to their previous assessments, feedback will inform them that a change has been detected and provide information about arranging a clinical assessment to rule out factors such as tiredness, distractions, or life events causing the detected drop in their cognitive performance.
• Have access to brain training games after completing their first round of assessments
• Can nominate a study partner
• Receive important messages through the application
• Manage their account through the application including being able to withdraw from the programme

Study partners:

• Register with the application
• Complete questionnaires about the patient each time the patient completes their cognitive assessments and questionnaires
• Receive important messages through the application
• May enrol in the REACTIVE programme as patients
• Manage their account through the application including being able to withdraw from the programme

Senior administrators:

• Manage accounts for support administrators to set up and revoke access
• Tasks as per support administrators

Support administrators:

• Register with the application
• Receive important alerts to facilitate action
• Search for a patient or study partner and view their basic information to help support queries
• Update information on behalf of the patient or study partner and withdraw them from the programme if required
• Have access to on screen and downloadable reports for operational management of the programme

Who built it?

The PROTECT research team at the University of Exeter built the application supported by funding from NIHR.

Product name exactly as registered.

PROTECT Digital Health Platform (implementing the REACTIVE application)

Product/catalogue/serial number (this is not the same as semantic software version number).

R1 V2

Intended Use

Read this instruction manual thoroughly before using REACTIVE. Please keep these instructions for future reference.

The intended use of the REACTIVE technology is to monitor cognition and dementia risk and to provide an early warning system for clinically meaningful cognitive decline for older adults aged 65 years and over living in the community.

Safety Instructions

These instructions are intended to reduce the risk of harm when using the PROTECT Digital Health Platform.

1. PROTECT Digital Health Platform (implementing REACTIVE) is not a diagnostic tool. Do not use PROTECT Digital Health Platform (implementing REACTIVE) to diagnose or treat any medical condition. If you are concerned about your memory, thinking, mood or any other symptoms, seek advice from an appropriate healthcare professional.
2. Do not ignore concerning symptoms because of your PROTECT Digital Health Platform (implementing REACTIVE) results. Always seek medical advice if your symptoms worsen or you have concerns about your health, regardless of the results displayed by the platform.
3. Do not self-diagnose or change your healthcare based solely on information provided by PROTECT Digital Health Platform (implementing REACTIVE). Clinical decisions should always be made in consultation with an appropriate healthcare professional.
4. Stop immediately if you feel unwell or unsafe during a physical assessment. Ensure you have sufficient clear space before starting any physical assessment and only continue if you feel able to do so safely.
5. If using PROTECT Digital Health Platform (implementing REACTIVE) causes anxiety or distress, stop using the platform and seek advice from your healthcare professional or the study team before continuing.
6. Only use your own PROTECT Digital Health Platform (implementing REACTIVE) account. Never access another person's account or allow anyone else to use yours.
7. PROTECT Digital Health Platform (implementing REACTIVE) - your account and personal information. Keep your login details confidential and report immediately if you believe someone else has accessed your account.
8. Provide accurate and truthful information. Your assessments and any clinical or research decisions may depend upon the information you provide.
9. Only provide another person's personal information where they have agreed for you to do so or where you are authorised to provide it on their behalf.
10. If you believe your personal details, assessment results or other information are incorrect, stop relying on the information and notify the study team promptly.

Cautions

The following guidance will help ensure PROTECT Digital Health Platform (implementing REACTIVE) operates correctly and your results are as accurate as possible.

1. Register only once. If you think you already have an account, do not create another one. Contact the study team if you cannot access your account.
2. Keep your contact details up to date so that reminders and other communications can reach you.
3. Complete cognitive tests honestly and to the best of your ability. Do not deliberately attempt to influence your results.
4. Read and follow all on-screen instructions before beginning an assessment.
5. Use PROTECT Digital Health Platform (implementing REACTIVE) on a supported device with an up-to-date operating system and web browser.
6. Maintain an internet connection while completing assessments where possible.
7. Check PROTECT Digital Health Platform (implementing REACTIVE), your email and your text messages regularly for reminders and important communications.
8. If you do not receive an expected reminder or invitation, contact the study team rather than assuming no further action is required.
9. Follow advice provided directly by your healthcare professional or research team even if you have not received a notification from PROTECT Digital Health Platform (implementing REACTIVE).
10. Be aware that emails, text messages or information displayed on your device may be visible to other people who use the same device.
11. Install software and security updates for your device when they become available.
12. Report technical problems, duplicate accounts, missing notifications or suspected errors to the study team as soon as possible.
13. PROTECT Digital Health Platform (implementing REACTIVE) is intended for adults aged 65 years and over.

General Precautions

Feeling worried or upset

This application monitors changes in your brain health over time. In some cases, it may suggest that further checks are needed although this could be down to everyday factors, such as tiredness and distractions.

Receiving this kind of information may make you feel worried, anxious, or upset. If this happens, please remember that we will support you through this and you will receive a follow up with our study doctor. You will not be left to manage this information on your own. Clear guidance and appropriate support will be provided to help you understand what the results mean and what to do next.

Tiredness or fatigue

Using the application for a long period of time, especially playing the brain training games that are always available, may make you feel tired. To mitigate this risk we have provided guidance on recommended usage levels on our brain training games and have time limits set on our cognitive tests. The application is designed to limit how often you receive reminders or prompts, to help prevent overuse.

Overexposure to cognitive tests

Taking cognitive tests too often may lead to fatigue and may affect how accurate your results are. This risk is mitigated by scheduling the cognitive tests at six-monthly intervals and limiting the number of cognitive test sessions at each assessment point to one short practice and one full-length session.

Using the app safely

There is a small risk of injury if you use the application in an unsafe environment (for example, while walking). To mitigate this use the application when you are in a safe, comfortable space away from distractions and where you can give the application your full attention.

Pre-Use Requirements and Dependencies

User pre-use requirements and dependencies:

• Regular access to a computer, tablet or smartphone device with the internet.
• There may be restrictions to using the application (e.g. a medical diagnosis) and these will be determined by an eligibility checklist within the application.

Software Installation, Upgrade and Configuration

Software installation:

Users will access the latest version of the site via the web url or on download from the app stores.

Upgrade:

There are no requirements for users to upgrade the software on the web application and users will be prompted to update via the App Store on their mobile device.

Configuration:

There is no configuration required on behalf of the user.

Step by Step Instructions (By User)

Patient Instructions (REACTIVE)

REACTIVE Website and Sign In / Out:

• The main website or application landing page will provide you with information about the REACTIVE programme.
• There will be a link on the landing page to join the study where you can start the registration onboarding process.
• Each time you visit the application you can select the sign in function where you will be asked to login using your username and password.
• You can logout by using the sign out button.
• The system automatically logs you out after 15 minutes of inactivity and you will need to log in again to resume to your activity.

Onboarding:

• You will be asked to give your preferred name.
• You will be asked to complete a pre-joining eligibility checklist to confirm you meet key requirements for using the REACTIVE application.
• You will be asked how you heard about us.
• You will create an account by providing your email address and a password.
• You will be sent an email with a link to verify your email and continue with registration.

Screening, consent and personal details:

• You will have the opportunity to read an information sheet that provides you with more information before you fully register.
• You will be asked to read a consent form and provide your consent to a series of statements about how we will collect and process your personal and sensitive information and to confirm you understand and agree to use the application as it is intended.
• You will be asked for some more detailed screening information to confirm you are eligible to use the application.
• You will be asked for some additional information including your contact details and GP details.
• You can update your personal details at any time through the website or applicationʼs manage account settings functions.
• You can withdraw your consent for us to collect and process your personal and sensitive data and delete identifiable information about you at any time through the applicationʼs manage account section.
• You can opt in to receive a regular newsletter containing news about brain health and current guidelines on how to keep your brain healthy and reduce your risk of dementia.

Tasks - health assessments and questionnaires:

• We will take some basic demographics details from you.
• You will be asked to complete your first brain health assessment. This is a set of tests to measure brain function (called a cognitive test battery), which need to be completed in full. You will first complete a short 5-minute practice session to make sure you understand how the tests work, and then the full session. The full session lasts for up to 50 minutes. The tests are designed to test different aspects of how your brain work, such as your memory, problem-solving and concentration. They are meant to be difficult and can be tiring. We ask you to do your best and try to avoid pausing or leaving the tests, although you can take a rest during the tests if you need to. If you do, you will need to return to the tests within 50 minutes. This is to make sure we get the most accurate information about your brain health on that day.
• You will be asked to complete a small set of questionnaires after your first brain health assessment.
• We will send you blood and saliva testing kits through the post for you to take at home and return to us through the post.
• You will be asked to complete another larger set of questionnaires about your physical health, mental health, lifestyle and wellbeing.
• We will ask you to repeat brain health assessments and questionnaires on a 6 monthly schedule as explained in the consent form. We will send you reminders when your assessments are ready.
• You will be given the option of inviting a friend or family member to use the application to provide information about you such as how well you can carry out certain day-to-day tasks. If you choose to invite someone to do this, you will be asked to provide their email address to send the invitation with information about the application. This person will be referred to as your Study Partner and will be asked to register and consent to use the application to provide information about you.
• If a friend or family member has consented to provide information about you, they will also receive reminders to complete questionnaires about you.

Feedback:

• We will check the cognitive test data you submit through the application to make sure it has arrived correctly and review your scores to see how you have done.
• We will give you feedback about your performance through the application.
• If your tests show a lower score than expected for someone of your age, our team will contact you to arrange a more detailed assessment with a study nurse or doctor.

Brain training games:

• After you have submitted your first full cognitive assessment, you can access a set of brain training games that help to maintain brain health. You can play these as often as you wish. The data from playing these games will be collected so we can see who is playing, and how often.

Manage account:

• You will be able to view basic information you have provided previously such as your name, address and GP details in the manage account section. If you have any changes to these details you can update the information here.

Communications:

• We will send you messages in the application and by email about using the application.
• We will ask you to complete occasional feedback forms to provide us with suggestions and feedback on your experience with using the application or website. These will be brief and optional.
• Our support desk will be available between 9am and 5pm at reactive@exeter.ac.uk

We recommend that if you experience any ill health or have concerns about your brain health you contact your GP for advice. You can also let us know by reporting a health update through the home / tasks page of the application.

Study Partner (REACTIVE)

Onboarding:

• When a patient has nominated you as their study partner you will receive an email with a link to take you to the study partner registration onboarding process.
• You will be asked to confirm your relationship the patient.
• You will complete a pre-joining eligibility checklist to confirm you meet key requirements for being a study partner.
• You will be asked to confirm your full name.
• You will then create an account by providing a password.

Consent:

• You will have the opportunity to decline the invitation to be a study partner.
• You will have the opportunity to read an information sheet that provides you with more information before you fully register.
• You will be asked to read a consent form and provide your consent to a series of statements about how we will collect and process your personal and sensitive information and to confirm you understand and agree to use the application as it is intended.
• You can withdraw your consent for us to collect and process your personal and sensitive data and delete identifiable information about you at any time through the website or applicationʼs manage account setting functions.

Tasks - Questionnaires:

• You will be asked to complete a small set of questionnaires about the patient you are supporting.

Manage account:

• You will be able to view basic information you have provided previously such as your name in the manage account section. If you have any changes to these details you can update the information here.
• If you would like to sign up as a patient and you meet the eligibility criteria you will be able to join the study as a patient from here.

Sign In / Sign Out:

• Each time you visit the application you can select the sign in function where you will be asked to login using your username and password.
• You can logout by using the sign out button.
• The system automatically logs you out after 15 minutes of inactivity and you will need to log in again to resume to your activity.

Communications:

• We will send you messages in the application and by email about using the application.
• We will ask you to complete occasional feedback forms to provide us with suggestions and feedback on your experience with using the application or website. These will be brief and optional.
• Our support desk will be available between 9am and 5pm at reactive@exeter.ac.uk

Senior Admin User (REACTIVE)

Developer Account Set Up:

• Senior Admin Users accounts will be set up by a developer upon request and agreed approvals.

Sign In / Sign Out:

• Each time you visit the application you can select the sign in function where you will be asked to login using your username and password.
• You can logout by using the sign out button.
• The system automatically logs you out after 15 minutes of inactivity and you will need to log in again to resume to your activity

Registration:

• When a Developer has added you as a support user you will receive an email with a link to take you to the support admin user registration process.
• You will be asked to create an account by providing a password.

Set up a Support Admin User:

• Support admin users can be added from the “Support users” menu item
• A list of support admin users will show as active, deactivated or pending
• Support users can be added from this page, deactivated and made active

Support Admin Users Other Tasks:

• The Senior Admin User can also carry out all tasks as defined under Support Admin User.

Support Admin User (REACTIVE)

Senior Admin Account Set Up:

• Support Admin Users accounts will be set up by a Senior Admin User upon request and agreed approvals.

Sign In / Sign Out:

• Each time you visit the application you can select the sign in function where you will be asked to login using your username and password.
• You can logout by using the sign out button.
• The system automatically logs you out after 15 minutes of inactivity and you will need to log in again to resume to your activity.

Registration:

• When a Senior Admin User has added you as a support user you will receive an email with a link to take you to the support admin user registration process.
• You will be asked to create an account by providing a password.

Manage alerts:

• From the support home screen you can view alerts that need to be managed.
• Alerts will display for key tasks that need to be managed that day.
• You can click on the alert from the support home page to view work to be done.
• Alerts can be acknowledged once completed.

Find users (patients and study partners):

• Users can be searched for by user name, registration ID, phone number, NHS number or person key.
• Once searched a user record will display with basic information about the user to enable support.
• Support admin users can also update personal details on behalf of the user from here.

Run reports:

• The support admin users can run pre-defined monitoring and management reports
• Reports will display on screen and some reports will display as a count while others will display patient level data.
• For some reports support admin users can copy to Excel to enable further manipulation of data outside of the system. Any data taken out of the system will be stored in the Secure Data Research Hub.

Troubleshooting

FAQs can be found on the REACTIVE website reactivestudy.org.uk

Help and Support can also be found within the application itself.

The REACTIVE Study Team Helpdesk can be contacted on working days between 9am and 5pm by email on reactive@exeter.ac.uk, by phone on 01392 727581 and by post at College House 1.23, St Lukeʼs Campus, Heavitree Road, Exeter, Devon, EX1 2LU.

Technical Specifications

REACTIVE software application uses the PROTECT Digital Health Platform.

The PROTECT Digital Health Platform will be hosted on a dedicated cloud environment with a secure data centre for redundancy and disaster recovery.

The platform also uses some Third party systems, for example, to send email communications.

Supported Devices:

• Smartphone or tablet with touchscreen functionality
• Desktop or laptop computer supported for web-based access

Operating systems / platforms:

• iOS: Version 15 or later
• Android: Version 10 or later
• Web browsers: Latest versions of Chrome, Safari, Edge, or Firefox

Connectivity requirements:

• A stable internet connection is required for:
  • Account access
  • Completion and submission of cognitive tasks
  • Synchronisation of data
• Interruption of connectivity during a session may result in incomplete or lost data.

Environmental conditions:

Please ensure you have a quiet environment free from distractions and you have enough time to complete the cognitive assessments.

User conditions:

• The application is intended for use by one user per session
• User should ideally keep to the same device each time they complete the cognitive assessments (touch or keyboard)
• Study partners (if applicable) should not assist with the cognitive assessments

Data Handling:

• Data entered into the application is securely transmitted and stored
• The platform maintains strict separation between personally identifiable information and results data keeping in separate databases against and ID.
• Personally identifiable information is only accessible by the REACTIVE study team where needed to communicate with the patient or their GP.

• BS EN ISO 13485:2016+A11:2021 - Medical devices. Quality management systems. Requirements for regulatory purposes
• IEC 62304:2006+A1:2015 software life-cycle processes
• BS EN ISO 14971:2019+A11:2021 - Medical devices - Application of risk management to medical devices
• DCB0129: Clinical risk management: its Application in the Manufacturer of Health IT Systems
• BS EN ISO 14155:2020 - Clinical investigation of medical devices for human subjects - Good clinical practice
• BS EN 62366-1:2015+A1:2020 - Medical Devices - Application of Usability Engineering to Medical Devices