A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening

NCT03984500 | Completed DMC

• 2 other identifiers: STUDY000001221R03HL146877-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Trait

Keywords

Sickle Cell Trait; Education

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (4)

• Percentage of Parents who receive on-site Sickle Cell Trait testing

  2 years

• Decisional Conflict Scale

  2 years

• Parental Anxiety

  2 years

• Sickle Cell Trait Testing Cost

  2 years

Study Arms (1)

Education

OTHER

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

Interventions

Education OTHER

SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult biological parents of children \<3 years old with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
• English proficiency will be required

You may not qualify if:

• 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.
• Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
• Parents who self-report that they have a child with SCD
• Parents who self-report that they have SCD.
• Parents who report that they or their partner is currently pregnant

Sponsors & Collaborators

• Susan Creary: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 36275941 DERIVED

MeSH Terms

Conditions

Sickle Cell Trait

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Susan Creary, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 13, 2019
• Study Start: June 18, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

US (1)