A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening
NCT ID: NCT03984500
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2019-06-18
2022-06-01
Brief Summary
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The study will determine the feasibility of implementing a SCT education program (SCTaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained SCT knowledge.
Detailed Description
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During phase I of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. This data will then be analyzed by the SCT Team in order to develop the Program.
During phase II of the study, population with the same criteria as phase I will be enrolled, however they will receive the revised "SCTaware" education. Pre and post education questionnaires will also be answered. In addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys.
In addition, the investigators will be using the Decisional Conflict Scale (DCS) to explore if parents experience decisional conflict about whether or not to obtain SCT testing and if SCTaware reduces this conflict
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Education
During phase 1 of this study parents who attend in person education sessions will be recruited to have their standard sessions video-taped, timed, and reviewed by the SCTaware Team. Subjects will complete before and after education questionnaires that will then be reviewed to see how much participants learned about SCT, how education was not clear and/or appropriate (too much medical jargon). The SCTaware education will then be created based on review of these videos and participants' survey responses.
For phase 2 of the study, the same recruitment strategy will be utilized. Participants will receive SCTaware and complete before and after questionnaires for evaluation. Participants in this phase will also complete follow-up questionnaires at 1 and 6 months.
Education
SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).
Interventions
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Education
SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).
Eligibility Criteria
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Inclusion Criteria
2. English proficiency will be required
Exclusion Criteria
2. Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
3. Parents who self-report that they have a child with SCD
4. Parents who self-report that they have SCD.
5. Parents who report that they or their partner is currently pregnant
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Susan Creary
OTHER
Responsible Party
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Susan Creary
Assistant Professor of Pediatrics
Principal Investigators
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Susan Creary, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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References
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Abrams MA, Zajo KN, Beeman CM, O'Brien SH, Chan PK, Shen Y, McCorkle B, Johnson L, Chisolm D, Barnard-Kirk T, Mahan JD, Christian-Rancy M, Creary SE. A Health Literate Approach to Address Health Disparities: a Virtual Program for Parents of Children with Sickle Cell Trait. J Commun Healthc. 2022;15(2):112-120. doi: 10.1080/17538068.2022.2026056. Epub 2022 Jan 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00000122
Identifier Type: -
Identifier Source: org_study_id