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A Program to Increase Sickle Cell Trait Knowledge Among Parent of Infants Identified in Newborn Screening (SCTaware)

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ClinicalTrials.gov Identifier: NCT03984500
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nationwide Children's Hospital

Brief Summary:

This is a study for parents of infants 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.


Condition or disease Intervention/treatment
Sickle Cell Trait Other: Education

Detailed Description:

This is a single center, observational study to develop an education program for parents of infants 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


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Study Type : Observational
Estimated Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comprehensive Program to Increase Sickle Cell Trait Knowledge and Awareness Among Parents of Infants Identified in Newborn Screening
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Phase I
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.
Other: Education
SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).

Phase II
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).




Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]
    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.

  2. Parental Sickle Cell Trait Knowledge [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Percentage of Parents who receive on-site Sickle Cell Trait testing [ Time Frame: 2 years ]
    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.

  2. Decisional Conflict Scale [ Time Frame: 2 years ]
    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.

  3. Parental Anxiety [ Time Frame: 2 years ]
    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.

  4. Sickle Cell Trait Testing Cost [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study requires participants to be able to understand communications in English and since the surveys have not been validated in other languages, participants or consenting adults will be required to speak English. Although other hemoglobinopathy traits besides S-trait are identified on newborn screening, S-trait is the most common SCT identified on the newborn screen and the content of these sessions is the most consistent.
Criteria

Inclusion Criteria:

  1. Adult biological parents of infants with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
  2. English proficiency will be required

Exclusion Criteria:

  1. Parents who self-report that they do not have functional verbal English (report that they are not proficient) or if they request an interpreter for the education session.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984500


Contacts
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Contact: Karina Woodling 614-722-3733 Karina.Woodling@nationwidechildrens.org
Contact: Myra Christian-Rancy 614-722-3690 Myra.Christian-Rancy@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Karina Woodling    614-722-3733    karina.woodling@nationwidechildrens.org   
Principal Investigator: Susan Creary, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Susan Creary, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Nationwide Children's Hospital:

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Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03984500     History of Changes
Other Study ID Numbers: STUDY00000122
1R03HL146877-01 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nationwide Children's Hospital:
Sickle Cell Trait
Education

Additional relevant MeSH terms:
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Sickle Cell Trait
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn