Participant Co-Design for Clinical Trials
(CONFIRM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The lessons researchers learn and evidence researchers discover from research studies are limited by who volunteered as participants in each research study. Currently, research studies do not represent the full diversity of the American people. Community engagement is one method to increase research participation. But, there is a lack of evidence for recommending a particular level of community engagement over others. This team of scientists, physicians, and community members developed an innovative approach to increase full participation of participants in research studies. The proposed project, Co-creating Novel, Feasible, and Inclusive Research Methods (CONFIRM), is designed to test if researchers can increase research participation by creating methods in partnership with the research participants themselves.
As the team has conducted research around breast cancer, these researchers have repeatedly encountered Black women who see the importance of the overall topic and want to help people like them. But when they hear about what exactly they have to do as part of the study, they do not volunteer. This team wants to change that. Researchers plan to recruit participants to answer research questions, and then with those volunteers, researchers will decide together on the tasks and activities volunteers will complete in the study. In contrast to how researchers usually do science, this innovative approach switches the order of design and participant recruitment. Researchers enroll and engage volunteers before methods are selected. This team engages research participants as "co-researchers." This word emphasizes the act of carrying out research with/by participants who are not professional researchers, instead of to/about/for them. The team proposes that participants will design a method that is acceptable, feasible, and relevant to themselves and their community.
Researchers will recruit 240 participants from community sites, such as health fairs, retail stores, churches, and schools, who will be divided into two groups based on where they signed up for the study. Half of the participants will complete research procedures (survey, health measurements, blood draw) as the research team designed them before the study started. The other half of participants will work with the research team to adjust the procedures to be acceptable and relevant to the participants before completing the revised procedures. Researchers predict that the group of participants who co-design procedures will have a higher completion rate of inidividual items and stay in the study for longer than the group of participants who complete the pre-designed procedures.
By demonstrating the effectiveness of this innovative approach, researchers aim to empower people to become more involved in research.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Participant Engagement
Participants are recruited and engaged as co-researchers to co-design study procedures
Implementation
Participants complete research procedures, either pre-designed or co-designed with researchers
Follow-up
Participants are monitored for retention and data completeness across two data collection cycles
What Are the Treatments Tested in This Trial?
Interventions
- Participant co-design
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Augusta University
Lead Sponsor
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