The level of support provided by caregivers during clinical trials can be very variable. This can range from providing emotional support by regularly checking on how the study participant is doing, to being more deeply engaged in the clinical trial journey. In the latter situation, caregivers may provide assistance to help study participants attend their trial visits or accompany study participants during their visits. Additionally, caregivers may regularly complete questionnaires regarding their patients. Through these regular activities, caregivers’ responsibilities can be very important.
As this role is unique in clinical trials, we need to make sure that completing Observer Reported Outcomes (ObsROs) is as easy as possible, while maintaining data quality.
Here are 4 key recommendations to successfully implement a clinical trial involving caregivers:
1- Enhancing comfort for caregivers: it’s key to provide the option to complete ObsROs on any type of device.
- Offering multiple modes of eCOA collection will provide study participants with more opportunities to collect data and will offer them a choice to use what is more relevant to them. Some patients or caregivers will prefer to use a provisioned device whilst for others, using their own device in a ‘Bring your own device’ (BYOD) mode will be more intuitive. Offering the option for an interview, and offering web-based solutions will also provide alternatives when using a handheld device is not ideal (e.g. if the patient has a disease that prevents them being able to easily hold a tablet or a phone, or if the caregiver feels more comfortable completing ObsROs from a computer).
- If studies are increasingly demanding to study patients, options should be provided in parallel to ensure a positive patient experience. Provisioning devices that allow data to be collected even when offline enhance flexibility and comfort for study participants.
- The option of switching data collection modes between patient and caregiver is also an important aspect for studies involving caregivers. As an example, a young study patient may be comfortable using a tablet at home, whilst the caregiver (likely a parent) might prefer to complete their questionnaires on their own phone in a BYOD mode.
2- Reducing burden for families: what about using the same device as the study patients?
A clinical study can be perceived as very cumbersome, with lots of procedures and materials to manage. To reduce the burden on families, Kayentis’ eCOA solution allows the use of a single device for multiple study participants.
- Caregivers and study patients can use the same device: for example, patients can complete their own questionnaires, and when they are finished, pass the device on to their caregiver, who will complete their questionnaires using their own credentials in their own time.
- If the study involves multiple caregivers, they can also use the same device if they wish, e.g. two parents can share the load and complete ObsROs on the same tablet, each of them having their own credentials. But equally they may prefer to use two different devices, and so such situations (e.g. families with separated parents) two devices can be provided. Data will be synced whether one or multiple devices are used, and the completion of data by caregiver 1 or caregiver 2 will be tracked in the audit trail.
3- Ensuring data quality for ObsROs: routing the caregiver to their relevant ObsROs in due course
Solid programming and branching logic will ensure that the relevant questionnaire will be selected for completion by the study patient or by the caregiver, according to the study participant’s status.
- For example, an 8-year-old child can complete their self-completed child PRO version, and when finished, their session will be complete, but the caregiver’s session will start and the parent will then have their own ObsRO to complete.
Another example is the completion of an adult patient’s status by site staff if the patient is very sick, confirming that the patient feels too unwell for being able to complete their questionnaire. In such a situation, the ObsRO mode can be activated, and the proxy version of the questionnaire becomes available to the caregiver.
4- Supporting families: training study participants
- The Kayentis Media Player (KMP) feature can be used to upload relevant and specific study patient and caregiver training material. Pdf and video files, in study participants languages, adapted to a participant’s age, can provide significant information regarding the value of their participation, and the central role that the caregivers play in the successful completion of the study.
- As it is key to support all study participants, the KMP can display the material in several languages, so that multi-cultural families can benefit from training material in the language that suits them best. When children and parents don’t have the same mother tongue, being able to display training material and supportive tools in the most appropriate language is key to support patients and caregivers from the study start and enhances the engagement of study participants.
Caregivers are key participants in clinical trials and assume considerable responsibility, it is therefore essential to engage well with caregivers at each step of a clinical trial. As well as bringing the same functionality and flexibility to caregivers as for study patients for eCOA data collection and patient engagement, Kayentis Clin’form solution goes further by offering multiple synergies in the data collection mode (e.g. single device for all stakeholders).
It also allows multiple caregivers to complete ObsROs for the same patient, which can provide some comfort to families and reduce the burden for caregivers.
It is only through thoughtful consideration of the burden for all study participants (i.e. caregivers as well as patients) that industry stakeholders will develop solutions that are usable and supportive for all.
