The ProofPilot Blog - Design, Launch & Participant in Research Studies

Group-Based Activities in Trials

A key aim at ProofPilot is to expand what we can run trials on. That includes activities that don’t fit the typical clinical site visit model. The traditional study visit model assumes a one participant to one professional interaction.

Group based research activities

Virtual trials are all the rage right now. Without any interaction from a study professional, participants complete study tasks using technology. That’s great. But, many complex study activities need a professional. So, ProofPilot supports a participant-centric version of the traditional in-person clinic visit. More than half of the studies on ProofPilot are hybrid virtual and in-clinic studies.

Self-service and one-on -one leaves out many important interventions. Many health activities happen in groups out in the real world. Health promotion classes, group therapy, fitness sessions. This functionality supports those scenarios.

For those who follow ProofPilot, you know of our interest in promoting good nutrition across various population groups. Recently, we started a pilot study with the University of Florida (which runs many USDA nutrition education programs) and Thrivemarket.com.

A large portion nutrition education for low-income individuals is funded through state and county grants by the USDA. These grants help support classes attended by low income individuals across the US.

Most of these classes are pop-ups. Meaning that nutrition outreach workers go into the community and set up classes in churches, food pantries, community centers and other central locations. Each class includes a cooking demonstration.

The staff for these efforts don’t have the time nor interest to also set up for a research study.

The instructor needs to focus on the class. It would be disruptive to individually enroll and ask questions of as many as 30 class participants as part of an evaluation.

SMS Recruit into Clinical Trials

Instead, prior to class, they access the ProofPilot code and number for that class. They post that number and code for all in the class to see.

Participants send the code to a special ProofPilot number and it records thier attendance at the group activity.

As part of a pilot program with the University of Florida and Thrivemarket, participants use this code to register attendance at a class.

If the user is already a participant in the study, ProofPIlot records the task as completed. Additional tasks trigger basd on your study design.

This is also an ideal opportunity to recruit particiapants into the study. If no record is connected with the users telephone number, ProofPilot automatically replies with an SMS invite for the user to officially join the study.

A click on the provided link will immediately take the user to the study recruitment page on ProofPilot for that study. There are no downloads required. No special technical skills. The group instructors and organizers are not bothered.

study recruitment page.

ProofPilot then walks the participant through a consumer-grade registration process. Most Americans, even at low income and education levels have signed up for a music service or ordered from Amazon. The ProofPilot registration experience will feel familiar.

Following registration to ProofPilot, the system will issue the next study tasks based on your protocol design. In this case, basic eligibility screener survey task. Each task starts with an introduction, and then continues to the task itself.

The next task in many study designs is the informed consent. Participants review the consent and accept. While they may ask questions of the program administrators, the process remains far more efficient than traditional person by person processes.

Once the participant accepts consent they are an official member of the study. In this study design, grocery credit rewards from Thrivemarket.com trigger after each class attendance.

ProofPilot recorded this participants attendance. Therefore, the grocery credit is immediately available to the participant. ProofPilot sends notification of the reward to the participant by push notification, SMS, or e-mail, depending on the participant’s communication preferences.

This is standard ProofPilot promotion code functionality and can be used to link external data collection, help users download apps, and fulfill interventional products, as it is here. They don’t have to use the reward immediately. It’s saved in the ProofPilot wallet. When they are ready, they can click to redeem.

ProofPilot automatically appends the promotion code to the users session at Thrivemarket.com. The user orders groceries and gets the $63 credit.

Almost all ProofPilot studies are longitudinal. Once the user is part of the study, each group task confirmation SMS triggers follow-up tasks based on your study design. The example study here includes 8 classes over the same number of weeks. Grocery credits trigger at some of those classes but not all.

ProofPilot is very excited about our support for group based study activities. We believe real world data comes from real world activities and environments. And a lot of those activities include a group of participants.

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