Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT06138145
• Collaborator: (none)
• Enrollment: 127
• Location: 1
• Arms: 4
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 13.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
African American Caregivers and Parents and Research Study Registries	Other: Video; Behavioral: Survey	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical Research Study Enrollment Videos: a Baseline Assessment Study
• Actual Study Start Date: Nov 17, 2022
• Actual Primary Completion Date: Aug 29, 2023
• Actual Study Completion Date: Aug 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Group A No Video w/ monetary incentive	Other: Video; Different videos were shown for Arms B and C. No Video was shown for Group A or D.; Behavioral: 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.
Experimental: Group B Generic video w/ monetary incentive	Other: Video; Different videos were shown for Arms B and C. No Video was shown for Group A or D.; Behavioral: 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.
Experimental: Group C Appeal video w/ monetary incentive	Other: Video; Different videos were shown for Arms B and C. No Video was shown for Group A or D.; Behavioral: 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.
Sham Comparator: Group D Non-Incentive and no video	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Intent [Up to 40 weeks]

   The primary outcome was intended to show who joined the research registry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion:

1. English speaking

2. Self-identified African or African American

3. Not already enrolled in 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 CHOP's registry, history of clinical trial participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHOP Primary Care, Cobbs Creek	Philadelphia	Pennsylvania	United States	19139

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Inclusion Study References

Publications

None provided.

• Responsible Party: Kevin Johnson, Kevin B Johnson, MD, MS, FAAP, FACMI, FIAHSI, FAIMBE David L. Cohen (Penn Integrates Knowledge) University Professor of Pediatrics, Biomedical Informatics, Computer Science and Science Communication, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT06138145
• Other Study ID Numbers: 22-019955
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kevin Johnson, Kevin B Johnson, MD, MS, FAAP, FACMI, FIAHSI, FAIMBE David L. Cohen (Penn Integrates Knowledge) University Professor of Pediatrics, Biomedical Informatics, Computer Science and Science Communication, University of Pennsylvania: Inclusion Study; African American Study; African American Pediatrics; Appeal Videos

Study Results

No Results Posted as of Nov 18, 2023