An interventional study of Education in Sickle Cell Trait, sponsored by Susan Creary. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Susan Creary · Not applicable, Interventional, and Other
This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution.
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.
This is a single center, observational study to develop an education program for parents of young children diagnosed with Sickle Cell Trait. This will be accomplish by evaluating the current Ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis.
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
43 studies on the registry are indexed under Sickle Cell Trait; 11 are open to participants now.
This study's enrollment of 74 is above the median of 63 across 22 interventional studies indexed under Sickle Cell Trait.
Browse Sickle Cell Trait studies →This is the only study on the registry with Susan Creary as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Education
SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).
Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured
The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured. The program will be feasible if the time to train the educator and deliver the education can be completed within the context of the current sickle cell trait education program in Ohio.
Time frame: 2 years
Parental Sickle Cell Trait Knowledge
Parental Sickle Cell Trait Knowledge will be measured before the education, immediately after the education, and 6 months after the education is provided using the 8-question Sickle Cell Trait Knowledge Assessment Measure. Parents that score 75% correct on this measure or higher will be considered to have high knowledge. The proportion of those parents who have high knowledge prior to the education will be compared to the percentage of parents that have high knowledge 6-months after receiving the education.
Time frame: 2 years
Percentage of Parents who receive on-site Sickle Cell Trait testing
On-site sickle cell trait testing will be available for all parents and will be ordered for all parents who accept this testing. The percentage of enrolled parents that accept and obtain on-site testing will be measured by the number of parents who accept this testing divided by the total number of parents who receive the education.
Time frame: 2 years
Decisional Conflict Scale
Parents will complete the 16 item validated decisional conflict scale survey before and after education to measure if parents' confidence or difficulty in making the decision whether or not to be tested for sickle cell trait improved with sickle cell trait education. These results are reported as a total score, with 5 sub-scores (uncertainty, informed, values clarity, support, and effective decision sub-scores). The total score and the sub-scores range from 0-100, with a score of 0 indicating no conflict/uncertainty and a score of 100 indicating extreme conflict/uncertainty.
Time frame: 2 years
Parental Anxiety
Parents will complete the state trait anxiety short from survey before and after receiving sickle cell trait education to measure if the education reduces parents' state anxiety about having a child with sickle cell trait.
Time frame: 2 years
Sickle Cell Trait Testing Cost
Parents will complete the sickle cell trait needs assessment survey that includes an item that asks participants if the cost of sickle cell testing impacted their decision whether or not to be tested for sickle cell trait.
Time frame: 2 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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