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RCT #5, Arm #2: Framing Method, Opt-Out for Cardiovascular Disease (BETTER P2 Trial)

N/A

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

must have active medical records in site's electronic medical record system.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three weeks after all attempts have been made to contact is made

Awards & highlights

BETTER P2 Trial Summary

This trial aims to find ways to increase the number of Black and Hispanic people participating in heart disease clinical trials. Currently, these groups are underrepresented in trials, which raises concerns about whether the trial results

Who is the study for?

This trial is for Black and Hispanic individuals with active medical records at the participating site. It aims to improve diversity in cardiovascular disease studies by testing different recruitment strategies.Check my eligibility

What is being tested?

The study tests various methods to boost enrollment of under-represented groups in heart disease trials, including incentive structures, message framing (like social proof or scarcity), opt-out options, contact methods, and appeals to altruism.See study design

What are the potential side effects?

Since this trial focuses on recruitment strategies rather than medical treatments, there are no direct physical side effects. However, participants may experience inconvenience or privacy concerns.

BETTER P2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BETTER P2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three weeks after all attempts have been made to contact is made

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three weeks after all attempts have been made to contact is made

This trial's timeline: 3 weeks for screening, Varies for treatment, and three weeks after all attempts have been made to contact is made for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Enrollment fraction of Black + Hispanic patients

Secondary outcome measures

Enrollment fraction by Area Deprivation Index (ADI) quartile

Enrollment fraction of Black patients

Enrollment fraction of Hispanic patients

+3 more

BETTER P2 Trial Design

16Treatment groups

Active Control

Group I: RCT #5, Arm #2: Framing Method, Opt-OutActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. Instead of receiving on how to enroll in the parent trial, thy will be told they have been "conditionally enrolled" in the parent trial, contingent on them providing some additional information, unless they choose to opt out.

Group II: RCT #6, Arm #4: Incentive Structure, Loss-framed, LotteryActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, their participant incentive (e.g. $50) will be placed in a virtual account that they will be able to access once they have enrolled into the parent trial.

Group III: RCT #2, Arm #2: Source of Contact, Research TeamActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The sender of the message will be the research team.

Group IV: RCT #6, Arm #1: Incentive Structure, Gain-framed, GuaranteeActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will be receive a guaranteed participation incentive (e.g. $50).

Group V: RCT #5, Arm #1: Framing Method, Opt-InActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. Instructions on how to enroll in the parent trial will be the same as all previous arms.

Group VI: RCT #4, Arm #2: Framing Method, Perceived ScarcityActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include language emphasizing constraints on enrollment/limited number of available spots for participating, i.e. perceived scarcity, For example, the message will include language such as: "There are a limited number of slots available in this study, and enrollment is only possible in the next 4 weeks."

Group VII: RCT #2, Arm #1: Source of Contact, Personal PhysicianActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The sender of the message will be the person's personal physician.

Group VIII: RCT #3, Arm #1: Framing Method, Appeal to AltruismActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will appeal to the person's altruism, for example: "Research studies like this one often do not include enough Black individuals. If Black people are not included in research like this, then doctors have less information about how cardiovascular disease might affect them and how new treatments could be used to improve their health. Your participation in this research can help doctors better understand how to treat members of your community in the future."

Group IX: RCT #3, Arm #2: Framing Method, No Appeal to AltruismActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include no appeal to altruism.

Group X: RCT #4, Arm #1: Framing Method, Social ProofActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include language about social proof, i.e. information about participation of individuals similar to the person being contacted. For example, the message will include language such as: "Clinical research studies and the development of effective new medications would not have been possible without the participation of thousands of people like you".

Group XI: RCT #6, Arm #2: Incentive Structure, Gain-framed, LotteryActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will state that, if the person decides to participate, they will receive a guaranteed participation incentive (e.g. $25) and also be enrolled in a lottery (e.g. 1 in 40 chance) to receive a larger participation incentive (e.g. $1,000).

Group XII: RCT #6, Arm #3: Incentive Structure, Loss-framed, GuaranteeActive Control1 Intervention

Group XIII: RCT #1, Arm #1: Contact Method, Text OnlyActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message via text message. This message will invite them to participate in the parent trial.

Group XIV: RCT #1, Arm #2: Contact Method, Email OnlyActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message via email. This message will invite them to participate in the parent trial.

Group XV: RCT #1, Arm #3: Contact Method, Email+TextActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message via email and text message. This message will invite them to participate in the parent trial.

Group XVI: RCT #4, Arm #3: Framing Method, No Social Proof, No Perceived ScarcityActive Control1 Intervention

Potential participants in the parent trial will be randomized to receive a message inviting them to participate in the parent trial. The message will include no language about social proof or perceived scarcity.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,842,367 Total Patients Enrolled

American Heart AssociationOTHER

326 Previous Clinical Trials

4,893,706 Total Patients Enrolled

Emory UniversityOTHER

1,640 Previous Clinical Trials

2,520,737 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for participants currently open in this clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this research endeavor is currently in the active recruitment phase. The study was initially posted on October 30th, 2023 and underwent its most recent revision on December 20th, 2023. A total of 39,920 patients are being sought for participation from a single designated site."

Answered by AI

What is the upper limit for the number of participants enrolled in this clinical trial?

"Indeed, the information on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking individuals to participate. The initial posting of the trial was on October 30th, 2023, and it was last updated on December 20th, 2023. This study aims to enroll a total of 39,920 patients across one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Promising Behavioral Economic Interventions to Promote Enrollment Diversity in Cardiovascular Cohort Studies

2023. "Testing Promising Behavioral Economic Interventions to Promote Enrollment Diversity in Cardiovascular Cohort Studies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05827718.