1. Implementing and Running an online Trial A Case Study Using The REACT Trial
Duncan Appelbe1,2, Heather Robinson3, Susie Dodd1,2, Andrew Walker3, Paula Williamson1,2 and Fiona Lobban3
1: Clinical Trials Research Centre, The University of Liverpool
2: North West Hub for Clinical Trials Methodology Research, Department of Biostatistics, The University of Liverpool.
3: SPECTRUM Centre for Mental Health Research, Lancaster University

2. Disclaimer
The REACT project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA), 14/49/34.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.

3. Participants are the Relative or close friend
What is REACT?
REACT is an online study to compare the effectiveness of a Relatives Education And Coping Toolkit (REACT) with an online Resource Directory. Half the people in the study will receive the REACT toolkit, and half will receive the Resource Directory.
Participants are the Relative or close friend
All Online !!!!

4. Participant Journey Through the Trial – Getting to the site
Participants directed to the REACT site from:
Posters in Clinic
Promotion by Mental Health Charities
Facebook adverts
Internet Search
Support Groups

5. Participant Journey Through the Trial – Getting Randomised
Check Geographic area
Online form, translated to word then ed
Check that we have a working contact number
Require Baseline Questionnaires to be completed prior to randomisation

6. Participant Journey Through the Trial – Access to the arms
TAU
REACT

7. Participant Journey Through the Trial – Follow up
12 Weeks x3
2x2 factorial
£10/20
(un)conditional
24 Weeks

8. & How did we get here …? Typical Trial Team CI Trial Manager
Data Manager IT
External Supplier for intervention site
Intervention site based on data collected in a Pilot Trial
&

9. Anything but straight forward ….
Identifying an external web design company to design and implement the intervention site, within the trial budget
Would also host site
Could not implement study questionnaires
Using typical trial databases would not be appropriate as they would turn off the subjects
Intervention Site –
WordPress
Registration/DC Site:
C# MVC, MySQL

10. Collect data …. Not just PROMs
Need to know how many people stop at each stage
Need to know why people have failed to progress
Started off with UA (linked to a user)
Data showed that events were missed, leading to a bespoke implementation
e.g. in a test of ~10 minutes interaction with ~30 page changes GA reported ~20% only!!

11. Collect data …. Not just PROMs
Recorded how much of a video participants watch
- Videos on YouTube
- Utilise YouTube JS API to determine percentage watched
- AJAX call to server every 5s on a page with a video
Call limited to pages with videos, otherwise we could overwhelm server, but more importantly
Would effect data usage from participant
Currently ~1M records recorded

12. Linking the two sites
AJAX Calls to C# end points sharing data via JSON
Secured using a secret key that changes on an hourly basis
Password reset
Reminder s

13. Automated Alerts ….
Need to send “info” if subjects answer GHQ or wellbeing answers are specific values – advice that would normally be given if face to face
Timed alerts if user is “stuck” at a given point for too long
Alerts to supporters on new posts

14. Study Dashboard

15. 68% 65% Where are we up to ..? 1st Randomisation April 2016
Recruitment to date 546 out of 666 12 24
68%
65%

16. Lessons Learnt
Focus Groups are important – But You need to know when to say stop changing things
You need to redress the balance of the trial team – more IS specialties involvement
This also includes the TMG!

17. Lessons Learnt Think about what data you want in advance
Think about what metrics you need to help you manage the study

18. The Good news …
Online trials still have challenges, but can be rewarding
Caveat : Think about the demographic!

19. Acknowledgements Fiona Lobban Susie Dodd Heather Robinson
Lizzi Collange
Sue Flowers
Andrew Walker
Susie Dodd
Paula Williamson
Naomi Bacon
Emma Bedson
Clare Jackson