Patient ParticipationNCT06138145

Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

A study testing Video and Survey in people with Patient Participation and Pediatric ALL, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Patient Participation, Pediatric ALL
What is being tested?: Video and Survey
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2022to 29 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

CHOP Primary Care, Cobbs Creek
Philadelphia, Pennsylvania, 19139

Other trials in United States

About this study

Official title: Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical Research Study Enrollment Videos: a Baseline Assessment Study

Read the 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.

Conditions: Patient Participation, Pediatric ALL
Being tested: Video, Survey
Keywords: Inclusion Study, African American Study, African American Pediatrics, Appeal Videos
Medical subject headings: Patient Participation, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06138145
Study group	Role	What they receive
Control	Experimental	Text introduction from the Registry, with a gift card. Receives: Other: Video; Behavioral: Survey
Generic	Experimental	Video detailing the Registry's objectives, no tailoring, with a gift card. Receives: Other: Video; Behavioral: Survey
Appeal	Experimental	Generic video edited to include a tailored appeal, with a gift card. Receives: Other: Video; Behavioral: Survey
Ink pen (no) Incentive:	Sham comparator	Similar to control but received a University ink pen. Receives: Behavioral: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry
Number of Participants with who made the decision to enroll in the CHOP pediatric clinical trials registry.
Measured: Up to 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202229 Aug 2023

First posted18 Nov 2023
Study start17 Nov 2022
Primary completion29 Aug 2023
Study completion29 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patient ParticipationStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06138145
Sponsor's protocol ID: 22-019955
Status last verified: Apr 2025
First submitted: 8 Nov 2023
Last updated: 18 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Johnson KB, Iannone SL, Furth SL, Taylor L, Tan ASL. Culturally Tailored Messages and Trial Registry Enrollment: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444229. doi: 10.1001/jamanetworkopen.2024.44229.
PubMed 39531233

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingObservational study
Implementing Dynamic Consent for Rare Disease Patients
Rare Disorders
Recruiting
Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings.
Shared Decision Making
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke

All Patient Participation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical Research Study Enrollment Videos: a Baseline Assessment Study
ClinicalTrials.gov ID: NCT06138145
Acronym / sponsor ID: 22-019955
Conditions: Patient Participation, Pediatric ALL
Keywords: Inclusion Study, African American Study, African American Pediatrics, Appeal Videos
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Children's Hospital of Philadelphia
Study start: 17 Nov 2022 (actual)
Primary completion: 29 Aug 2023 (actual)
Study completion: 29 Aug 2023 (actual)
First posted: 18 Nov 2023 (actual)
Results: Posted 18 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Control	Experimental	Other: Video, Behavioral: SurveyText introduction from the Registry, with a gift card.
Generic	Experimental	Other: Video, Behavioral: SurveyVideo detailing the Registry's objectives, no tailoring, with a gift card.
Appeal	Experimental	Other: Video, Behavioral: SurveyGeneric video edited to include a tailored appeal, with a gift card.
Ink pen (no) Incentive:	Sham comparator	Behavioral: SurveySimilar to control but received a University ink pen.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VideoDifferent videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups	Other	Appeal, Control, Generic
SurveySurvey 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.	Behavioural	Appeal, Control, Generic, Ink pen (no) Incentive:

Primary outcome

Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry
Time frame: Up to 40 weeks
Number of Participants with who made the decision to enroll in the CHOP pediatric clinical trials registry.

Results and safety

Results posted to the registry on 18 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	29	29
Generic	30	30
Appeal	34	33
Ink Pen (no) Incentive	32	32

Primary outcome: Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry

Time frame: Up to 40 weeks. Count of participants. Unit: Participants

Measure	Control n = 29	Generic n = 30	Appeal n = 34	Ink Pen (no) Incentive n = 32
Value	29	30	34	32

Control vs Generic vs Appeal vs Ink Pen (no) Incentive: p <0.001, Chi-squared
Control vs Generic vs Appeal vs Ink Pen (no) Incentive: p <0.05, Mann-Whitney U test
Control vs Generic vs Appeal vs Ink Pen (no) Incentive: p <0.05, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Adverse events were not monitored in this study, as participation concluded immediately upon completion of the survey. This study was classified as low risk, as it involved only the collection of survey responses without any medical interventions, treatments, or procedures. Given the minimal risk associated with survey-based research, ongoing safety monitoring was not required. Participants were informed that they could discontinue the survey at any time if they experienced discomfort.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Control	0 of 0	0 of 0
Generic	0 of 0	0 of 0
Appeal	0 of 0	0 of 0
Ink Pen (no) Incentive:	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Several factors may affect the interpretation of this study. The sample was drawn from a few urban sites, which could limit the representation of marginalized groups. The fourth study arm was recruited six months later, potentially influencing baseline trust and timing. Participants knew about the incentive before consenting, which may have shaped trust perceptions. Only baseline self-reported data were collected, with no follow-up to assess changes in trust or knowledge after the intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39531233Johnson KB, Iannone SL, Furth SL, Taylor L, Tan ASL. Culturally Tailored Messages and Trial Registry Enrollment: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444229. doi: 10.1001/jamanetworkopen.2024.44229.
Inclusion Study ReferencesLink provided by the sponsor.

Related trials for Patient Participation

Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingObservational study
Implementing Dynamic Consent for Rare Disease Patients
Rare Disorders
Recruiting
Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings.
Shared Decision Making
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Video and Survey in people with Patient Participation and Pediatric ALL, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry (time frame: Up to 40 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.