As the principal investigator (PI) for ObvioHealth, a digital clinical research organization (CRO), I can describe first-hand the challenges of meeting the enrollment goals of a clinical trial while maintaining patient engagement throughout. Reducing drop-outs (post-enrollment discontinuation of the participants) is a critical component of any successful study, as lost data points can lead to the need for further recruitment (requiring additional time/resources). In this article, I will provide an example of a clinical trial our team has conducted while utilizing a digital hybrid model (minimizing site visits/maximizing the use of virtual site). We met the dropout allowance in this trial by preserving patient engagement.
Before delving into the metaphorical antidote for dropouts, let’s diagnose the main problem areas that contribute to patient withdrawal in the traditional setting:
• Required Resources: the patient is required to spend time/money on trips to the doctor’s office for study tasks related to informed consent, prescreening/screening/treatment period and end-of-study processes.
• Lack of Engagement: restricted communication between the patient and study team/doctor can negatively impact study participation. Patients might find themselves waiting for an appointment to ask pertinent questions to the study’s PI, forgetting to complete required study tasks (product consumption, completion of questionnaires, etc.), or the inability to report health/medication changes in real-time.
Our team recently completed a clinical trial tasked with measuring the efficacy of a dietary supplement as an intervention for adults with an elevated blood pressure, or stage I hypertension. Study protocol required the enrollment of 128 patients and established a 25% dropout allowance at a statistical power of 85%, confirming the number of participants needed to achieve the study endpoints. By employing a hybrid study model, sustaining patient engagement, and reducing resources required of the patient and study team, we successfully beat the dropout allowance.
The following breakdown details the steps taken to reduce dropout during each stage of post-enrollment:
• Start of Post Enrollment: Once enrolled in the study, we digitally randomize participants by utilizing our digital application (used to conduct virtual trials). Upon completion of randomization, the study product is ready to be shipped. Imagine the comfort of being able to track the delivery to your front door. By using our app, while awaiting the study package, participants can complete baseline tasks – so they can promptly begin the treatment period upon receiving the product.
• Treatment Period: A true disappearing act – minimized physical site visits brought to you by a hybrid study model which allows you to participate in the study from comfort of your home. Consistent alerts via the ObvioHealth app boost engagement by reminding patients to consume the study product/complete questionnaire(s), daily. Finally, our appprovides a medium for real-time communication between the study team and participant. Our study team monitors gaps in questionnaire responses and can flag this activity. Consider the benefits of being able to report changes in health in real-time, avoiding the hassle of contacting the doctor’s office and awaiting a response.
• End-of-Study: Product return/destruction is streamlined in the digital study. Conversely, in the standard format, one might forget to return the study product during the final trip to the clinic. Then, patients are left literally spinning wheels to return to the clinic with the study product (using time/resources). Our team can provide a shipping label and end-of-study questionnaires electronically to the participant, allowing them the freedom to skip out on the clinic visit.
At last, an uncomplicated formula consisting of only two variables: real-time interaction with the study team and inclusion of a hybrid study model. This pairing allows for the study to become available at the finger-tips of the patient from the comfort of their home. We’ve designed our app to make this concept a reality, ultimately reducing the burden placed on the patient, and in turn, limiting dropouts.