Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

University of Pennsylvania

Status: Completed

Conditions: Pediatric ALL; Patient Participation

Treatments: Behavioral: Survey; Other: Video

Study type: Interventional

Funder types: Other

Identifiers

NCT06138145

22-019955

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 125 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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125 participants in 4 patient groups

Control

Experimental group

Description:

Text introduction from the Registry, with a gift card.

Treatment:

Other: Video

Behavioral: Survey

Generic

Experimental group

Description:

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

Treatment:

Other: Video

Behavioral: Survey

Appeal

Experimental group

Description:

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

Treatment:

Other: Video

Behavioral: Survey

Ink pen (no) Incentive:

Sham Comparator group

Description:

Similar to control but received a University ink pen.

Treatment:

Behavioral: Survey