Combined ePRO and eDiary: what about using a single device?
1 July 2017
Why customers and users choose the Kayentis “Phablet” solution rather than a smartphone or tablet?
With the increasing importance direct patient input into clinical trials most protocols combine Quality of Life and ePRO questionnaires for use on site with eDiary questionnaires for use at home. This allows the evaluation of complementary areas such as disease-related symptoms, physical/ social/ emotional aspects, symptomatic adverse events, treatment compliance, and patient satisfaction.
Recently, for the initiation of new programs or for project bids, we have seen an increasing use of the Kayentis “Phablet” solution for the collection of combined ePRO and eDiary data. As such, we would like to outline the key advantages of using the “Phablet” particularly in terms of the benefits for the patient, site, and sponsor.
What is the added value of our phablet device?
Phablets combine the capabilities of smartphones and tablets. Although larger than a smartphone, phablets tend to be smaller and thinner than tablets, making them more portable (the screen size varies between 5-7 inches). This is the ideal user-friendly handled device for home-based eDiaries.
Why do users and customers prefer to combine ePRO and eDiary data collection on the same device, the Kayentis “Phablet”?
The main advantage is the size of the screen, which has many benefits including better ergonomy, better display of assessment scales, the possibility of data entry in landscape mode, and large buttons. Additionally, using only one device, the Phablet, is simpler and more efficient than using two separate devices. Some advantages are summarized below:
- Kayentis’ phablet has both supervised and unsupervised modes, and as such the same phablet can be used both on-site and at home.
- It is simpler and easier to use one device than two devices (for the site and for the patient). Patient-engagement is also improved by the use of a single device, since the same device is used in the same way both at home and on-site.
- Simplified training and documentation.
- Use of the device on-site if the patient forgets his/her own device at home.
- Preparation of the devices and back-up devices, shipment and logistics will be simplified since the number of devices sent, resupplied, reused or reallocated at the site will be lower.
- The amount of spare stock is reduced.
What are the key benefits for the patient?
- Ease of use is simplified by having a single device at home and on-site.
- Patient comfort and ease of use are important in certain pathologies or populations (e.g. elderly or pediatric patients): both are improved by using a large device with, e.g., more legible font sizes, larger buttons, and high resolution.
- Factors such as screen size and the best ergonomic fit have been taken into account. A generous screen size is particularly important in the completion of Visual Analog Scales or the use of images in some questionnaires that require completion of Patient-Reported Outcomes (PROs) and/or an eDiary.
- The handheld phablet device has high quality touch screens is very intuitive and easy to use – this is key to increasing data quality while ensuring patient compliance in the completion of the questionnaire, and also helps the patient to remain actively involved and engaged with the trial.
What are the main advantages for the site?
- Ease of use and training the patient are improved by using a single device in the same way at home and on-site. When used on-site, the investigator initiates the visit and invites the patient to complete the PRO. At the end of the visit, the investigator returns the phablet to the patient. The phablet can then be used by the patient in the unsupervised mode so that the eDiary can be completed between visits.
- The Kayentis interface for reviewing patient questionnaires on the phablet device ensures higher data quality and helps to increase site engagement. A clear overview is provided on the phablet, and the review process includes a complete audit trail that is recorded centrally in Kayentis’ Clin’Form application.
- eCOA Logistics, device reuse, and patient reallocation are simplified. For the clinical staff, the reduction in work during the trial set up or during a site visit reduces the administrative monitoring burden for logistics and data source checks, which can be crucial for the success of the clinical trial.
What is the added value for the sponsor?
- eCOA logistics, support, and training are simplified by being included on a single device instead of multiple devices.
- Significant time- and cost-savings on logistics and trial set up and management due to a lower number of devices will be lower.
- Patient engagement and compliance leads to happier, more engaged and efficient trial site staff meaning that the clinical interactions with the patient will be of higher quality.
In summary, the Kayentis Phablet devices offer huge benefits to combined ePRO and eDiary clinical trials, leading to better productivity and overall time savings while at the same time making life easier for the patient, and improving data quality, patient and site engagement, and trial compliance.
Contact us to learn more about how our Phablet solution can fit your trial requirements.
Frédérique MARION, Kayentis Business Development Director – July, 2017