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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Text introduction from the Registry, with a gift card. |
|
| Generic | Experimental | Video detailing the Registry's objectives, no tailoring, with a gift card. |
|
| Appeal | Experimental | Generic video edited to include a tailored appeal, with a gift card. |
|
| Ink pen (no) Incentive: | Sham Comparator | Similar to control but received a University ink pen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video | Other | Different videos were shown for the generic and appeal groups. No videos were shown to the control or ink-pen incentive groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 40 weeks |
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Inclusion:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHOP Primary Care, Cobbs Creek | Philadelphia | Pennsylvania | 19139 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39531233 | Derived | 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. |
| Label | URL |
|---|---|
| Inclusion Study References | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No Video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
| FG001 | Generic | Generic video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
| FG002 | Appeal | Appeal video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
| FG003 | Ink Pen (no) Incentive | Non-Incentive and no video 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No Video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 40 weeks |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Text introduction from the Registry, with a gift card. Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin B. Johnson | University of Pennsylvania | 215-573-5885 | Kevin.Johnson1@Pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 | Feb 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| Survey | 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. |
|
| BG001 |
| Generic |
Generic video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
| BG002 | Appeal | Appeal video w/ monetary incentive Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. |
| BG003 | Ink Pen (no) Incentive | Non-Incentive and no video 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Generic video edited to include a tailored appeal, with a gift card.
| OG003 | Ink Pen (no) Incentive | Similar to control but received a University ink pen. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Generic | Video detailing the Registry's objectives, no tailoring, with a gift card. Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Appeal | Generic video edited to include a tailored appeal, with a gift card. Video: Different videos were shown for Arms B and C. No Video was shown for Group A or D. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Ink Pen (no) Incentive: | Similar to control but received a University ink pen. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |