Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2023-08-29

Brief Summary

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An informational video about joining a Research Notification Registry is being compared with a version of the video tailored to African/ African American parents, reminding them about the importance of their being included in clinical trials. African/African American parents and caregivers of children under 13 years of age are targeted.

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Detailed Description

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Improving diversity in research projects and national data repositories is critical to providing safe and effective care to marginalized groups. Unfortunately, certain groups such as African Americans are inadequately represented in much of the available data and in current clinical trials. Recently, investigators have begun employing new messaging approaches to increase diversity in clinical trial enrollment. These messages are typically designed to inform, with no appeal for specific groups to act, and no tailoring that takes into account specific groups. Very little is known about the potential impact of inclusion appeals--direct appeals to historically marginalized groups calling on their need to be included in research studies. Applying the science of appeals to recruitment messages may improve the effectiveness of educational videos and lead to greater participation in research. This pilot study proposes to empirically study whether an inclusion appeal increases decisions to enroll children in studies.

Conditions

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Patient Participation Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Text introduction from the Registry, with a gift card.

Group Type EXPERIMENTAL

Video

Intervention Type OTHER

Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups

Survey

Intervention Type BEHAVIORAL

Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.

Generic

Video detailing the Registry's objectives, no tailoring, with a gift card.

Group Type EXPERIMENTAL

Video

Intervention Type OTHER

Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups

Survey

Intervention Type BEHAVIORAL

Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.

Appeal

Generic video edited to include a tailored appeal, with a gift card.

Group Type EXPERIMENTAL

Video

Intervention Type OTHER

Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups

Survey

Intervention Type BEHAVIORAL

Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.

Ink pen (no) Incentive:

Similar to control but received a University ink pen.

Group Type SHAM_COMPARATOR

Survey

Intervention Type BEHAVIORAL

Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.

Interventions

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Video

Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups

Intervention Type OTHER

Survey

Survey about participant's demographics, information source trust, and clinical trials knowledge. Also includes question about whether the participant is interested in enrolling in the Pediatric Trials Notification System.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. English speaking
2. Self-identified African or African American
3. Not already enrolled in any research participant registry, no history of clinical trial participation
4. At least one child in their care age newborn to 13

Exclusion:

1. Parents with children over the age of 13
2. Non-English speakers
3. Previously enrolled in Children's Hospital of Philadelphia registry, history of clinical trial participation

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes